BlisterCPMS User Manual — Version 3.0 · April 30, 2026 · Internal — Confidential
BlisterCPMS is a comprehensive, GMP-compliant Change Parts Management System purpose-built for pharmaceutical manufacturing. It unifies three distinct packaging domains — Blister (primary packaging), Cartoning (secondary packaging), and Tablet Tooling (compression tooling) — into one integrated web platform.
The system manages the full lifecycle of change parts: from procurement and inventory tracking through changeover execution, compliance documentation, and retirement. Every action is electronically signed where required by 21 CFR Part 11 and captured in an immutable audit trail.
All three domains share the same GMP Compliance Centre, Work Order engine, Change Order engine, Warehouse & Supply, Document Library, and Analytics & Reports modules — ensuring consistent audit trails regardless of packaging type.
Use Google Chrome 110+, Microsoft Edge 110+, or Mozilla Firefox 110+. JavaScript must be enabled. Recommended screen resolution: 1440 × 900px or wider.
BlisterCPMS uses a Role-Based Access Control (RBAC) model with granular permission sets assigned by the System Administrator.
| Role | Description | Typical User | Key Capabilities |
|---|---|---|---|
| ADMIN Full Access |
System Administrator — unrestricted access including System Settings | IT Admin, QA Manager | User management, role assignment, system configuration, backup, master data, all CRUD operations |
| PRODUCTION_MANAGER / PM Elevated Access |
Production Manager — elevated write access; can create and approve orders; no access to System Settings | Production Manager, Engineering Lead | Create/approve change & work orders, manage templates & kits, performance analytics, bulk create |
| Standard User Read + Limited Write |
Operator, technician, or viewer with permissions defined individually per feature area | Line Operator, Technician, QA Reviewer | View dashboards, execute assigned orders, record movements, upload documents |
PART_CREATE / MACHINE_CREATE / PRODUCT_CREATECHANGE_ORDER_APPROVEANALYTICS_VIEW + elevated accessCOMPLIANCE_VIEWContact your System Administrator to adjust your permission set. Administrators manage this in Settings → User Management and Settings → Role & Permissions.
The application uses a persistent collapsible sidebar on the left, organized into domain sections, plus a top navigation bar with notifications and user profile.
/notifications) — system alerts, pending approvals, overdue items, inventory warnings/profile) for personal details and password changehttp://local.blistercpms.com). The public Home page appears./signin./change-password./landing. The sidebar is fully visible with all modules available for your role.Sessions expire after a period of inactivity. The system redirects you to /signin automatically. Unsaved form data is lost — save frequently.
Navigate to /signup to create a new account if self-registration is enabled by your administrator. New accounts receive the lowest permission level until promoted by an ADMIN in Settings → User Management.
The Global Dashboard (/landing) provides a real-time operational overview. It has six tabs:
Summary KPI cards: total active change orders, open work orders, inventory alerts, OEE average, overdue items, and compliance score. Quick-navigation buttons to common workflows.
Active and pending change orders and work orders across Blister and Tooling. Status distribution, overdue counts, recently completed orders with drill-down links.
Part inventory health: critical parts, low-stock alerts, expiring items, reorder recommendations across all warehouse locations. Direct links to the Parts Inventory module.
Blister machine status: operational vs. maintenance vs. offline machines, OEE per machine, upcoming maintenance due dates, and performance trend indicators.
Trend charts for changeover durations, OEE over time, inventory value, supplier delivery performance, and compliance score trend. Designed for daily operational review.
High-level management summary: SLA compliance rate, total changeover cost, schedule adherence, deviation count, regulatory readiness. Suitable for weekly/monthly management reviews.
Under the Blister sidebar section, Dashboard (/dashboard) shows KPIs specifically scoped to blister primary packaging lines.
The Part Inventory module is the master repository for all blister change parts — forming tools, sealing jaws, guide plates, format parts, and consumables. It tracks stock levels, part condition, serial numbers, batch numbers, expiry dates, location assignments, and maintenance schedules. Every movement and adjustment is logged in the immutable audit trail.
Orange tabs require ADMIN or PRODUCTION_MANAGER role.
Full paginated list of all parts with search, filter, and sort. Filters include: Status, Criticality, Part Type, Material Type, Batch Number, and Serial Number. Cards can be toggled to list or grid view. Each part row shows part number, name, stock quantity, status chip, criticality, and action buttons (View, Edit, Delete).
Parts flagged as Critical (criticalityLevel = CRITICAL or HIGH) that require priority monitoring. Searchable and paginated. Red/amber indicators alert users to stock below minimum levels.
Parts where current stock quantity is at or below the minimum stock level. Shows current qty vs. minimum and reorder point. Quick-action buttons link to the inventory adjustment modal.
Parts approaching or past their expiry date. Sorted by expiry date ascending. Shows days until expiry highlighted in red if overdue. Typical for calibrated gauges, certified tools, and time-limited consumables.
Parts that have reached or fallen below their reorder point. Displays supplier, lead time, and recommended order quantity. Supports CSV export for purchasing workflows.
Parts scheduled for maintenance — based on expected lifespan hours, actual runtime, or calendar date. Linked to the Maintenance Schedule page (/parts/maintenance).
Charts and KPIs for inventory turnover, cost distribution by category, movement history trends, criticality breakdown, and stock health score.
| Page | Route | Description |
|---|---|---|
| All Parts | /parts | Main parts list with 7-tab view described above |
| Add Part | /parts/add | Comprehensive form to create a new part: basic info, dimensions, stock levels, lifecycle, costs, location assignment. Requires PART_CREATE permission. |
| Inventory Dashboard | /parts/inventory | Stock adjustments, lot management, stock-in/stock-out operations. Modals for Adjust Stock, Add Stock. Shows current inventory per location. |
| Movement Tracking | /parts/movements | Full audit log of all part movements: transfers between locations, issues to machines, returns, adjustments. Filterable by part, date range, movement type. |
| Maintenance Schedule | /parts/maintenance | Calendar and list view of scheduled and overdue part maintenance tasks. Create, complete, and track maintenance records. |
| Serial Unit Tracking | /parts/serial-units | Track individually serialised units — location, installation status, machine position, runtime hours, remaining lifespan. |
| Categories | /categories | Manage part categories (see §4). Accessible from the Parts submenu and directly. |
Go to /parts/add. The form is split into tabs: Basic Info, Dimensions, Stock, Lifecycle, Costs, Location & Notes.
Enter: Part Number (unique), Name, Description, Barcode/QR Code, Part Type, Format Size, Pocket Size, Track Count, Material Type, and flags (Critical, Spare, Consumable, Serialised).
Enter: In Stock quantity, Minimum Stock Level, Maximum Stock Level, Reorder Point, Safety Stock, and Lead Time Days. These thresholds drive all inventory alert calculations.
Enter Lifespan Hours (for runtime-based maintenance alerts), Unit Cost, Replacement Cost, Currency, Supplier, Manufacturer, and Expiry Date if applicable.
Select the warehouse storage location and category from the master data lists. These assignments are required for inventory management and reporting.
Click Save Part. After saving, use the Part detail page to add Machine–Part and Product–Part compatibility records (see §7).
Go to Parts → Inventory Dashboard. Click Add Stock. Select the part, enter quantity, batch/lot number, expiry date, supplier, and receiving location. An audit movement record is created automatically.
Click Adjust Stock and select movement type ISSUED. Enter quantity and destination (machine or work order reference). Available quantity is reduced immediately.
Select movement type TRANSFER. Choose source location and destination location. Useful when reorganising stock or moving parts from quarantine to available storage.
Select movement type ADJUSTMENT. Enter the correct physical count, reason for adjustment, and your change reason. The delta is captured in the audit trail with your user identity and timestamp.
The Available quantity = In Stock − Allocated (reserved). When a Change Order reserves parts, their allocated quantity increases — reducing available stock even though the physical stock has not moved. Always check Available (not just In Stock) when planning new change orders.
The Products module is the drug product catalogue — each product represents a pharmaceutical product manufactured on the blister lines. Products are linked to compatible machines and parts, forming the basis for changeover planning and compatibility validation.
Full paginated list of products with search and filters (Format Size, Track Count, Active status, Product Family, Development Stage, Priority Level, Sort By). Columns: Product Code, Product Name, Format Size, Track Count, Development Stage, Priority. Supports Add Product modal (ADMIN only).
Charts showing product distribution by format size, track count, active vs. inactive ratio, priority breakdown, and change order frequency per product over the last 90 days.
Products grouped by Product Family (e.g., Analgesics, Cardiology, Oncology). Each family card shows product count, formats, and active status summary. Product families are defined in Settings → Master Data → Product Families.
Products grouped by Development Stage: CONCEPT → DEVELOPMENT → PILOT → PRODUCTION. Shows progression and counts per stage — useful for new product introduction (NPI) tracking.
Shows critical parts associated with each product — the parts that are most important for that product's changeover. Filters to show only HIGH and CRITICAL criticality parts per product. Helps ensure critical parts are stocked before planning a changeover.
| Page | Route | Description |
|---|---|---|
| Add Product | /products/add | Create new product: Product Code, Name, Format Size, Track Count, Development Stage, Priority, Product Family, Manufacturer, description, and linked parts/machines. ADMIN only. |
| Manufacturers | /manufacturers | List, add, edit, and view drug product manufacturers. Fields: Name, Country, Contact, Certificates, Status. |
| Product–Part Compatibility | /product-part-compatibilities | Compatibility matrix between products and parts. Define which parts are required, compatible, or incompatible for each product. |
| Product–Machine Compatibility | /product-machine-compatibilities | Define which blister machines can run each product. Includes qualification status, approved format sizes, and OEE targets. |
| Changeover Templates | /change-orders/templates | Reusable changeover templates linked to products. See §8 of this Part. |
| Part Kits | /change-orders/kits | Predefined part kits linked to products and machine combinations. See §8 of this Part. |
Only products in PILOT or PRODUCTION development stage can be selected in Change Orders. CONCEPT and DEVELOPMENT stage products are locked from production use until formally promoted by an ADMIN.
The Blister Machines module manages the full lifecycle of blister packaging machines — registration, maintenance scheduling, performance analytics, and part/product compatibility mapping. Every machine has a complete digital record from commissioning to decommissioning.
Running normally. Eligible for change order scheduling and work order assignment.
Under planned maintenance. Cannot be selected for new COs until maintenance is completed and status returns to OPERATIONAL.
Unplanned downtime or breakdown. A deviation record is automatically generated. Blocked from all production scheduling.
| Tab | Fields Covered |
|---|---|
| Basic Info | Machine Name, Serial Number, Asset Tag, Machine Model (from master data), Production Line, Physical Location, Manufacturer, Year of Manufacture, Commissioning Date |
| Technical Specs | Format capabilities (min/max dimensions), number of track lanes, max sealing temperature, rated throughput (blisters/min), forming film and lidding material compatibility |
| Maintenance | Maintenance interval (hours or months), last maintenance date, next maintenance date (auto-calculated), maintenance SOP reference, assigned maintenance technician |
| Performance | OEE target %, current rolling OEE %, MTBF (Mean Time Between Failures), MTTR (Mean Time To Repair) |
| Qualification | IQ/OQ/PQ completion dates and document references, current qualification status, requalification due date |
| Page | Route | Description |
|---|---|---|
| All Machines | /machines | Machine list with search, filters, add/edit/view actions |
| Add Machine | /machines/add | Create new machine record. Requires MACHINE_CREATE permission. |
| Maintenance Schedule | /machines/maintenance | Calendar and list of scheduled, active, and overdue maintenance tasks per machine. Shows next due dates and maintenance history. |
| Performance Analytics | /machines/performance | OEE trend charts, downtime analysis, changeover time averages, and performance benchmarking per machine. Requires ANALYTICS_VIEW. |
| Machine–Part Compat. | /machine-part-compatibilities | Define which parts are compatible with each machine, including fit tolerance, qualification status, and approved combinations. |
| Machine–Product Compat. | /product-machine-compatibilities | Shared with the Products module — machine side view of product compatibility. |
If a machine passes its scheduled next maintenance date without a completed maintenance record, the system automatically generates a compliance alert and the machine's status chip turns amber. The GMP Compliance score is penalised until the maintenance record is completed and reviewed.
Categories provide hierarchical classification for blister change parts. A well-defined category structure simplifies search, reporting, and inventory management across large parts catalogues.
All categories displayed in card or list view. Each card shows category name, part count, low-stock count, and status. Supports Add Category modal (ADMIN). Categories can be viewed in card or list format.
Distribution charts: parts per category, total inventory value per category, low-stock ratio per category, and category utilization in change orders over the last 90 days.
Tree view of the category hierarchy showing parent–child relationships. Useful for understanding the full classification structure. Categories can have sub-categories for granular organization (e.g., Forming Tools → Flat Form Tools → Oval Pocket).
All categories that have at least one part below its minimum stock level. Helps identify which product families or part types have supply gaps. Sortable by severity (number of under-stocked parts per category).
Create a hierarchy of at most 3 levels deep. Example: Top Level (Forming Tools, Sealing Tools, Format Parts, Consumables) → Level 2 (Flat Form Plates, Deep Form Plates) → Level 3 (Oval Format, Round Format). More than 3 levels creates navigation complexity without benefit.
The Warehouse & Supply section covers Storage Locations, Suppliers, and Manufacturers. These modules track where parts are physically stored and who supplies them.
Manages all physical storage locations — shelves, racks, cold rooms, quarantine areas, and line-side staging areas.
List of all storage locations with name, warehouse code, capacity, current utilization %, temperature control flag, and status. Supports Add Location modal (ADMIN/PM).
Visual utilization percentage bars showing how full each location is. Sortable by utilization. Highlights overutilized locations in red (>90%) and locations with recent overflow alerts.
Tree diagram showing the physical hierarchy: Building → Floor → Zone → Aisle → Rack → Shelf → Bin. Navigate the tree to find specific locations. Click any node to see its contents and part list.
Locations with temperature-controlled storage (refrigerated, frozen, controlled room temperature). Shows current temperature settings and compliance status. Alerts when temperature monitoring data indicates out-of-range conditions.
Charts for total capacity vs. used capacity, empty vs. occupied slots, locations with high turnover, and cost-per-location metrics. Helps identify consolidation opportunities and under-utilised areas.
Detailed capacity management view: maximum part count per location, current count, available slots, and overflow warnings. Supports the Manage Capacity modal for adjusting location limits as physical layouts change.
Manages external part suppliers — contact information, delivery performance, preferred status, and sourcing agreements.
Full list of suppliers with name, country, contact info, active status, and part count. Supports Add Supplier modal.
Supplier performance metrics: on-time delivery rate, average lead time, quality score, return rate, and deviation count linked to parts from this supplier. Sortable and exportable to CSV.
Suppliers flagged as preferred — approved, reliable suppliers for critical parts. Shows preferred status criteria and last review date.
Suppliers capable of fast/expedited delivery — useful when critical parts are urgently needed. Shows typical lead time in days for standard vs. expedited orders.
The Document Library stores all GMP-relevant documents: SOPs, technical drawings, calibration certificates, qualification protocols, work instructions, and regulatory submissions. All documents are version-controlled with mandatory review cycles.
| View / Route | Description |
|---|---|
| All Documents /documents | Full document list: Title, Type, Version, Status, Linked Entity (part/machine/product), Owner, Last Review, Next Review. Supports Upload and Add Document modals. |
| Expiring Soon /documents/expiring | Documents approaching their next review date (configurable warning window, default 30 days). Sorted by days-to-expiry. Allows quick reassignment or review completion. |
| Overdue Reviews /documents/overdue | Documents past their review due date. Shows overdue by (days), responsible owner, and escalation status. Compliance risk indicator per document. |
Navigate to /documents and click Add Document. Fill in the document metadata form.
Select the document type (SOP, Work Instruction, Technical Drawing, Calibration Certificate, etc.) and enter the version number (e.g., V1.0). The system tracks all version history.
Link the document to the relevant entity — a specific part, machine, product, or change order. This allows the document to appear contextually when viewing those records.
Click Upload File to attach the physical file (PDF, DOCX, XLSX, DXF, etc.). Set the Next Review Date and assign a reviewer. The system generates alerts 30 days before the review date.
Documents overdue for review are flagged in the AI/GMP Audit Module and reduce the compliance score. Each overdue SOP or qualification document is treated as a finding. Resolve all overdue document reviews before any scheduled regulatory inspection.
BlisterCPMS maintains three cross-reference compatibility matrices that are essential for accurate changeover planning. These three-way matrices ensure the right parts are selected for the right product on the right machine, and that no incompatible combination can be used in a change order.
When creating a Change Order, the system cross-checks all three compatibility matrices simultaneously. A part linked to a product but not to the machine will still fail validation. All three compatibility records must be in place for a part to be usable in a CO.
Defines the relationship between drug products and blister change parts. For each product-part combination you can specify:
Defines which parts can be physically installed on each blister machine. For each machine-part combination you can specify:
Defines which blister machines can manufacture each product. For each product-machine combination:
Part Kits and Changeover Templates are the two productivity tools that enable fast, consistent, and error-free change order creation. They encode the engineering knowledge of what parts are needed and what steps to follow for a specific machine–product combination.
Without kits and templates, every change order requires manual part selection and step definition — which is slow and error-prone. With a correctly defined kit and template, creating a new change order for a known machine–product combination takes under 2 minutes: select the kit, select the template, set the schedule, and submit for approval.
A Part Kit is a predefined collection of all change parts required to changeover a specific machine from one product format to another. Kits are created once by engineering and reused for every changeover of that type.
Go to /change-orders/kits and click New Kit. Requires PM or ADMIN role.
Give the kit a clear name (e.g., "Uhlmann B1240 — Aspirin 500mg to Paracetamol 1g"). Select the machine model, From Product, and To Product.
Use the Add Part button to add each required part with quantity. The system filters to only show parts that are compatible with the selected machine and products. Add all required, spare, and consumable parts.
Review the complete parts list, total count, and estimated cost. Click Activate Kit to make it available for use in change orders. Inactive kits are hidden from CO creation.
A Changeover Template defines the step-by-step procedure for a specific machine model and change type. It is the digital equivalent of a changeover SOP — containing all steps that must be executed, their sequence, and any enforcement gates (LOTO, two-person checks, etc.).
| Template Field | Description |
|---|---|
| Template Name | Descriptive name (e.g., "Uhlmann B1240 Full Format Change — Standard") |
| Machine Model | The machine model this template applies to |
| Change Type | FORMAT_CHANGE / PRODUCT_CHANGE / MAINTENANCE / PARTIAL_CHANGE / TOOLING_CHANGE |
| Estimated Duration | Total expected changeover time in minutes — used for scheduling and OEE Availability calculation |
| Required Skill Level | Minimum operator qualification level required to execute this template |
| Steps | Ordered list of steps, each with: Name, Instructions, Step Type, Mandatory flag, Estimated Duration, Required Skill, Requires 2-Person Sign-off flag |
| Linked SOP | Reference to the approved SOP document in the Document Library that this template is based on |
| Status | DRAFT / ACTIVE / OBSOLETE — only ACTIVE templates appear in change order creation |
| Step Type | Description | Gate Requirement |
|---|---|---|
| PREPARATION | Pre-work: gather parts, review SOP, confirm personnel readiness | None |
| REMOVAL | Remove current format parts from the machine | LOTO must be LOCKED before this step can start |
| INSTALLATION | Install new format parts and tooling | LOTO must be LOCKED |
| ADJUSTMENT | Mechanical adjustment — torque, alignment, clearance settings | LOTO must be LOCKED |
| INSPECTION | Visual inspection of installed components | Optional second-person verification |
| VERIFICATION | Dimensional verification with calibrated gauges | Mandatory two-person sign-off |
| CLEANING | Machine cleaning steps contributing to line clearance | Cleaning agent type and quantity logged |
When a changeover template is updated (e.g., after a process improvement or SOP revision), the previous version is archived but not deleted. All historical change orders retain a reference to the template version active when they were created — preserving a complete record of what procedure was followed, which is critical for regulatory inspection.
Part 3 covers the full Change Order lifecycle, Approval Workflow, Line Clearance, LOTO, Electronic Signatures (21 CFR Part 11), First Article Inspection, Deviation Management, Audit Trail, and Batch Records. Open part3-change-orders-compliance.html to continue.
A Change Order (CO) is the primary regulatory document that authorises and records a machine format change. Every physical changeover must have a corresponding approved change order. Access via Change Orders (/change-orders).
Under FDA 21 CFR Part 211 and EU GMP Annex 15, no physical changeover may begin without an approved and documented change order. Starting work before CO approval is a regulatory violation and will appear in the audit trail.
| Change Type | Description | Required Approval |
|---|---|---|
| PRODUCT_CHANGE | Full format change to a completely different product formulation | L3 — QA Manager |
| FORMAT_CHANGE | Same product, different blister format dimensions | L2 — QA Engineer |
| MAINTENANCE | Machine maintenance-related part swap (non-product) | L1 — Supervisor |
| EMERGENCY | Unplanned urgent replacement during production | L2 + post-hoc L3 |
| TOOLING_CHANGE | Tablet tooling punch/die set swap | L2 — QA Engineer |
| PARTIAL_CHANGE | Subset of parts changed (e.g., single failed part) | L1 — Supervisor |
Navigate to Change Orders and click + New Change Order. The CO number (CO-YYYY-NNNN) is auto-generated and cannot be changed.
Select the machine being changed over, the current product running (From Product), and the target product (To Product). The system checks compatibility and calculates the required approval level.
Set the Scheduled Start Time and Scheduled End Time. The system automatically checks for scheduling conflicts — if another CO is already planned for this machine in this time window, you will see a conflict alert.
In the Parts tab, either select a pre-configured Part Kit (recommended) or add individual parts. The compatibility engine validates each part against the target machine and product.
In the Template tab, select the changeover SOP template that matches this machine model and change type. The template defines all the execution steps.
Confirm whether this CO requires: LOTO (required for all physical changeovers), FAI (required for product and format changes), and Line Clearance (required for product changes).
Set status to PLANNED and click Submit for Approval. This notifies the L1 approver via in-app notification and email. The CO is now locked from editing until the approval process is complete.
Click Reserve Parts to create inventory reservations for all parts in this CO. This prevents other COs from taking the same stock. The CO moves to PARTS_RESERVED status.
For complex production scenarios with multiple interdependent change orders, the Dependency Graph component (visible in the Change Order Detail page) provides an interactive visual map of CO blockers and dependents.
A CO that is marked as "blocked by" another CO cannot transition to IN_PROGRESS until all blocking COs are COMPLETED. This rule is enforced automatically by the system. Use dependencies when a downstream CO depends on an upstream format being established first.
The approval workflow is a 21 CFR Part 11 compliant multi-level electronic approval chain. Each approval level captures an immutable electronic signature with a cryptographic hash.
You will receive an in-app notification and email when a CO is pending your approval. Click the notification to go directly to the CO detail page. You can also see all pending approvals on your dashboard.
Review all sections: machine and product details, parts list and compatibility, schedule, risk score, changeover template, and any supporting documents. The system shows you the complexity score and risk score automatically calculated.
Click Approve (or Reject with a reason). Enter your e-signature credentials — your username and a reason/certification statement. The system generates a tamper-proof signature hash and records the immutable timestamp.
If more approval levels are required, the next approver is automatically notified. Once all required levels are approved, the CO is unlocked for execution (status → IN_PROGRESS when the operator starts).
If a CO is rejected at any approval level:
The system enforces that the CO creator cannot approve their own change order. If you created the CO, your approval action button is disabled. Another qualified user at the required approval level must be the approver.
The system monitors the time between CO submission and scheduled start. If an approval is still pending within a configurable window of the scheduled start time (e.g., 4 hours), the system generates escalation notifications to the approver and their supervisor.
Line clearance is the cleaning and verification process performed before production can switch to a new product on a blister line. It is a regulatory requirement to prevent cross-contamination. Access via Change Orders → Line Clearances (/change-orders/line-clearances).
| Clearance Type | When Performed | Key Checks |
|---|---|---|
| PRE_CHANGEOVER | Before starting format change — confirms previous product is fully cleared | Visual inspection, documentation removal, residue test if required |
| POST_CHANGEOVER | After format change — before production restarts | All checks including new format verification, LOTO release confirmation |
| PRODUCT_RESIDUE | Cross-contamination specific check after product change | Swab test, residue detection, analytical limits compliance |
| CLEANING_VERIFICATION | Routine cleaning verification between campaigns | Visual + residue test per SOP interval |
Each line clearance record supports a detailed item-level checklist. Each checkpoint must be confirmed individually before the overall clearance can be marked COMPLETED:
| Checkpoint Category | Examples | Status Options |
|---|---|---|
| VISUAL | Machine interior clear, no product residue on surfaces, no broken parts | PENDING PASSED FAILED WAIVED |
| RESIDUE | Swab test results within acceptance criteria, rinse sample analysis complete | |
| DOCUMENTATION | Batch records from previous run removed, new batch record in place | |
| EQUIPMENT | Correct format parts installed, tooling specification matches product | |
| REGULATORY | Electronic signature obtained, LOTO released, FAI status confirmed |
A change order cannot transition to COMPLETED unless its linked line clearance record is in COMPLETED status with all mandatory checklist items PASSED or WAIVED with justification.
LOTO (Lockout/Tagout) is an OSHA 1910.147-compliant energy isolation procedure that protects operators from
hazardous energy release during machine servicing. BlisterCPMS enforces LOTO as a mandatory gate in the
changeover execution workflow. Access via the Compliance page → LOTO tab (/compliance).
The system blocks physical changeover steps until LOTO is in LOCKED status. This is a patient safety and operator safety control. Attempting to bypass LOTO will be recorded in the audit trail and will immediately flag a CRITICAL deviation.
The LOTO record requires confirmation of isolation for each applicable energy type:
Main power isolated and locked. Lockout device applied to main disconnect.
Air supply valves closed. Residual pressure bled and confirmed zero.
Hydraulic circuits depressurised. Reservoir isolated.
Heating zones cooled below safe touch temperature. Steam supplies isolated.
Elevated components blocked or lowered. No stored mechanical energy.
LOTO release requires a second person. The person who applied the lock cannot be the same person who releases it.
All regulated approvals in BlisterCPMS are captured as electronic signatures fully compliant with FDA 21 CFR Part 11. Electronic signatures are cryptographically secured, immutable, and cover all regulated document types — not just change orders.
| Field | Description | Tamper Protection |
|---|---|---|
| Signature ID | Unique identifier — never reused | Globally unique, system-generated |
| Signer Name & Role | Authenticated user at time of signing, with their role | Resolved from your secure login session — cannot be impersonated |
| Signed At | Server timestamp — immutable | Set by the server at the moment of signing — cannot be backdated by a user |
| Action | APPROVED / REJECTED / ACKNOWLEDGED / CERTIFIED | Validated server-side against allowed values |
| Approval Level | 1, 2, or 3 | Verified against your assigned role permissions |
| Signature Hash | Cryptographic fingerprint of the signed data | Any change to the underlying record invalidates the hash — tampering is detectable |
| Integrity Verified | Confirms the record has not been modified since signing | Automatically re-checked during AI/GMP Audit |
| Linked Record | The specific record this signature applies to | Covers Change Orders, Line Clearances, Batch Records, FAI, and Deviations |
| Reason / Certification Statement | Signer's stated reason for approval | Entered during signing — included in the cryptographic hash |
The system can verify the integrity of any stored signature at any time by re-checking its cryptographic hash against the stored data. Any discrepancy — indicating tampering — immediately flags the record as compromised and generates an audit alert. This check is run automatically as part of the AI/GMP Audit score calculation.
BlisterCPMS electronic signatures meet 21 CFR Part 11 requirements for: unique identification of the signer, timestamp, signature meaning displayed to signer, and cryptographic link between signature and record. Any post-signing alteration to the record is detectable.
FAI is the final quality gate after every changeover. A sample of blisters produced immediately after format change is inspected against dimensional and functional specifications. Access via Compliance → FAI tab (/compliance).
Production work orders cannot start until FAI result is PASS (or CONDITIONAL_PASS with additional QA e-signature). A FAIL result automatically sets the change order to FAILED status and blocks all production.
| Field | Description | Specification Source |
|---|---|---|
| Sample Size | Number of blisters inspected (default: 10) | Configurable per product |
| Pocket Depth Measured | Actual pocket depth measurement (mm) | Must be within ProductSpecificationEntity min/max tolerances |
| Pocket Depth Pass | Auto-calculated: YES if within specification | Driven by ProductSpecificationEntity |
| Seal Integrity Pass | Seal pressure test result | Visual + bubble/dye test result |
| Print/Marking Verification | Correct product name, batch number, expiry format | Product specification and packaging artwork |
| Overall Result | PASS / FAIL / CONDITIONAL_PASS | QA Engineer judgment |
| Result | Automatic System Action | Manual Action Required |
|---|---|---|
| PASS | Change order gate opened. Work order can transition to IN_PROGRESS. | None — proceed with production |
| CONDITIONAL_PASS | Gate remains open but additional QA e-signature prompt appears. | QA Engineer must provide additional e-signature with justification before work order can start |
| FAIL | Change order → FAILED. Work order → QUALITY_HOLD. Deviation automatically created. | Investigate root cause. Correct the issue (re-install, re-adjust). Create new FAI record after correction. |
A Deviation is a formal record of any event that departs from the approved changeover procedure. Access via Compliance → Deviations (/compliance/deviations).
| Field | Options / Description |
|---|---|
| Deviation Number | Auto-generated: DEV-YYYY-NNN (e.g., DEV-2026-042) |
| Severity | CRITICAL — immediate hold | MAJOR — urgent CAPA | MINOR — standard CAPA |
| Deviation Type | PROCESS / EQUIPMENT / MATERIAL / DOCUMENTATION / ENVIRONMENTAL |
| Root Cause | Detailed description of why the deviation occurred |
| Immediate Corrective Action | Action taken immediately to address the deviation |
| CAPA Plan | Long-term Corrective and Preventive Action plan |
| CAPA Deadline | Date by which CAPA must be completed (generates escalation alert if missed) |
| Status | OPEN → UNDER_INVESTIGATION → CAPA_OPEN → CLOSED |
A CRITICAL deviation automatically: (1) places the associated change order ON_HOLD, (2) places the associated work order on QUALITY_HOLD, (3) triggers immediate notifications to the QA Manager and Plant Manager. The CO and WO cannot resume until the CRITICAL deviation is resolved and QA Manager approves the resumption.
The BlisterCPMS audit trail is an immutable, append-only log of every change to regulated entities. It is the cornerstone of 21 CFR Part 11 compliance — providing a complete, tamper-evident record of who did what, when, and from where. Access via Compliance → Audit Log tab (/compliance).
The audit log is write-once — records can never be modified or deleted after they are written, not even by system administrators. Each record contains a tamper-detection hash computed at the moment of creation.
| Field | Description |
|---|---|
| Record Type | Which type of record was changed (CHANGE_ORDER, PART, WORK_ORDER, etc.) |
| Linked Record | UUID of the specific record that was changed |
| Display Name | Human-readable name (e.g., "CO-2026-0042 — Uhlmann B1240") |
| Action | CREATE / UPDATE / DELETE (soft) |
| Field Name | Which field was changed (for UPDATE events) |
| Old Value / New Value | Before and after values for every field change |
| User Name | Who made the change (from your authenticated login session) |
| Action Timestamp | Immutable server timestamp (not client-provided) |
| IP Address | Source IP of the client that made the change |
| Session Reference | Login session identifier |
| User Agent | Browser/device identification |
| Change Reason | Reason provided by the user for the change |
| Integrity Hash | Tamper-detection hash of the entire record payload — verifiable at any time |
| Site / Branch | Multi-site segregation fields |
The audit log viewer supports the following filters:
Electronic batch records consolidate all regulated documentation for a production run into a single, QA-auditable package. Access via Compliance → Batch Records (/compliance/batch-records).
| Section | Data Included |
|---|---|
| Header | Batch number, product, machine, production date, batch size, shift |
| Change Order Reference | Linked CO number, approval chain summary, changeover duration actual vs. planned |
| Line Clearance | Clearance record reference, clearance status, verified by, verification date |
| LOTO Reference | LOTO record ID, locked by, released by, energy isolation confirmation summary |
| FAI Results | Inspection record ID, measurements, pass/fail result, inspector and date |
| Parts Used | All parts used during the changeover with lot numbers and quantities |
| Production Data | Quantity planned vs. produced vs. rejected, production records by hour |
| OEE | Calculated OEE (Availability × Performance × Quality) for this batch |
| Deviations | Any deviations raised during this batch (linked deviation numbers) |
| QA Sign-off | E-signature of QA Engineer who reviewed and released the batch record |
Batch records become read-only after QA electronic sign-off. No fields can be modified after the QA release signature. Corrections must be made via a formal addendum deviation record. Batch records are retained for a minimum of 5 years per 21 CFR Part 211.192.
A change order can only transition to COMPLETED when ALL six gates are satisfied:
Part 4 covers advanced modules: Tablet Tooling, Work Orders & Production, Changeover Execution Workflow, Cartoning Integration, AI/GMP Audit Module, and the Notification System. Open part4-advanced-modules.html to continue.
The Tablet Tooling module manages the complete lifecycle of compression tooling — upper punches, lower punches,
and dies — used in tablet press operations that feed blister packaging lines. Tooling quality directly affects
blister pocket geometry, tablet embossing, and sealing integrity. Access via Tooling (/tooling).
TSM (Tablet Specification Manual) — North American standard for compression tooling dimensions.
EU (European Pharmacopoeia) — European standard for punch and die dimensions.
IPT (International Pharmaceutical Tooling) — International harmonised tooling standard.
Each tooling set is associated with one of these standards, ensuring dimensional conformance checks are applied correctly.
| ACTIVE | Available for use in change orders |
| INACTIVE | Not currently in service |
| QUARANTINE | Isolated pending investigation |
| RETIRED | Permanently decommissioned |
| UNQUALIFIED | Not yet qualified — cannot be used |
| IQ_COMPLETE | Installation Qualification done |
| OQ_COMPLETE | Operational Qualification done |
| PQ_COMPLETE | Performance Qualification done |
| QUALIFIED | Fully qualified — eligible for use |
Only tooling sets with Status = ACTIVE and Qualification Status = QUALIFIED can be selected in a change order. Non-qualified tooling sets do not appear in the selection list.
| Operation | When | Status Transition |
|---|---|---|
| Check Out | Before a changeover — item issued to the production floor | AVAILABLE → CHECKED_OUT |
| Check In | After changeover — item returned from floor | CHECKED_OUT → IN_INSPECTION |
| Inspect | Post-use inspection against dimensional specs | IN_INSPECTION → AVAILABLE (pass) or IN_RECONDITIONING (fail) |
| Recondition | Send to tooling refurbisher for re-grinding | AVAILABLE → IN_RECONDITIONING |
| Return to Storage | After reconditioning inspection passed | IN_INSPECTION → AVAILABLE |
| Retire | Item worn beyond reconditioning threshold | Any → RETIRED |
| Inspection Type | Trigger | What is Checked |
|---|---|---|
| INCOMING | New tooling received from manufacturer | Dimensional conformance to order specification, surface finish, hardness test |
| PERIODIC | Configurable interval (e.g., every 50,000 pressings or 6 months) | Wear measurement vs. tolerances, embossing sharpness, surface condition |
| PRE_CAMPAIGN | Before a production campaign starts | Full dimensional check, embossing legibility, no visible damage |
| POST_CAMPAIGN | After production campaign ends | Wear assessment, pressing count update, reconditioning recommendation |
| DAMAGE_ASSESSMENT | Following a suspected tooling incident (crash, contamination) | Full assessment including X-ray or metallurgical analysis if required |
Work Orders represent planned production runs. Each WO defines a product to be manufactured on a machine during
a specific time window, consuming the change parts installed by the preceding change order.
Access via Work Orders (/work-orders).
A work order is automatically placed in QUALITY_HOLD when any of these events occur:
The changeover execution workflow guides machine operators through a structured, step-by-step changeover procedure with regulatory enforcement gates built in. This is the module that operators use directly on the shop floor, typically on a tablet device.
| Step Type | Description | Special Gate |
|---|---|---|
| PREPARATION | Pre-work: gather parts, review SOP, confirm personnel | None |
| REMOVAL | Remove current format parts from machine | LOTO must be LOCKED |
| INSTALLATION | Install new format parts and tooling | LOTO must be LOCKED |
| ADJUSTMENT | Mechanical adjustment — torque settings, alignment | LOTO must be LOCKED |
| INSPECTION | Visual inspection of installed components | Optional second-person verification |
| VERIFICATION | Dimensional verification with gauges/tools | Two-person sign-off required |
| CLEANING | Machine cleaning steps (part of line clearance) | Cleaning agent logged |
Navigate to Change Orders and open the approved CO. Click Start Changeover to begin execution. The system creates execution records for each template step.
If the CO requires LOTO (mandatory for all physical changeovers), create the LOTO record and confirm all energy types are isolated before proceeding. The system blocks physical work steps until LOTO = LOCKED.
Steps are presented in sequence. For each step: read the instructions, perform the work, mark as COMPLETED (or DEVIATED if something goes wrong). Steps marked mandatory cannot be skipped.
If something goes wrong during a step, click Raise Deviation on that step. Set the severity and description. The step is marked DEVIATED and a formal deviation record is created automatically.
Work through the line clearance checklist item by item. Confirm each checkpoint PASSED (or WAIVED with justification). Complete the residue test if required for a product change.
After LOTO is released and line clearance is complete, perform FAI. Enter the dimensional measurements. The system auto-calculates pass/fail against product specifications. If PASS, click Complete Changeover.
In pharmaceutical packaging, the blister machine (primary packaging) feeds directly into the cartoner (secondary packaging). A product format change on the blister line requires a coordinated format change on the downstream cartoner. BlisterCPMS fully manages this integration with four dedicated cartoning screens. Access via Cartoning in the navigation.
Without coordinated management, blister and cartoning format changes can become misaligned — the blister is ready to run but the carton format hasn't been changed, or the leaflet batch is for the wrong product version. This causes unplanned stoppages and regulatory non-conformances. BlisterCPMS ensures both operations are verified READY before any production can start.
Access via /cartoning/specifications. Defines the carton format parameters for each product:
Access via /cartoning/leaflets. Manages the package inserts for each product:
| Field | Description |
|---|---|
| Leaflet Code | Unique identifier for this leaflet version |
| Version | Revision version (must match regulatory approved version) |
| Language | Target market language |
| Barcode Reference | Expected barcode value on leaflet — used for scan verification |
| Approval Status | Must be APPROVED before use in production |
| Supplier | Leaflet printer/supplier |
The barcode scanner on this screen allows cartoning line operators to scan the leaflet barcode before production starts. The scan result is verified against the approved barcode reference for the target product — a mismatch triggers an alert and blocks production.
Access via /cartoning/line-readiness. This is the critical go/no-go screen before production can start:
| Readiness Status | Meaning | What's Missing |
|---|---|---|
| NOT_READY | Multiple outstanding items | Check all sub-status items — multiple blockers |
| PARTIAL | Some items complete, some outstanding | Review sub-items to see what remains |
| READY | All checks passed — production may start | None — proceed with work order start |
| LOCKED_OFF | Line locked by QA — do not proceed | QA investigation in progress — await QA clearance |
The readiness check verifies all four of:
Production work orders cannot transition to IN_PROGRESS unless the linked line readiness status is READY. This is a hard system gate — operators cannot override it without Admin intervention.
Access via /cartoning/production-dashboard. Provides a unified view of both the blister and cartoning change orders on the same production line — enabling production coordinators to see the complete changeover picture in one screen, including timing, responsible personnel, and readiness sub-items for both machines.
The AI/GMP Audit module provides automated GMP compliance scoring and readiness assessment. It analyses the
current state of all regulated data in the system — open deviations, overdue CAPAs, pending approvals, FAI
failure rates, audit trail completeness — and generates a scored compliance readiness report.
Access via Compliance → AI/GMP Audit (/compliance/ai-gmp-audit).
The AI/GMP Audit module is unique to BlisterCPMS among blister-line-specific platforms. Competing systems (Uhlmann UPS, Romaco DCM) offer no equivalent. IMA Digital offers an optional ML add-on but not a fully integrated GMP-specific audit capability.
Counts open deviations by severity. CRITICAL items heavily penalise the score. Overdue CAPAs trigger additional deductions.
Change orders awaiting approval beyond the deadline window. Stale approvals indicate process bottlenecks.
Percentage of FAI records with FAIL or CONDITIONAL_PASS results over the rolling 30-day window.
Checks that all regulated entities have appropriate audit records. Flags any records with broken integrity hashes.
Verifies all completed change orders have the required approval level signatures. Missing signatures are flagged.
Checks for stockout events, expired lot records, overdue maintenance parts, and expired certifications.
| Score Range | Status | Recommended Action |
|---|---|---|
| 90–100% | EXCELLENT — Inspection Ready | Maintain current processes. Schedule next audit review in 30 days. |
| 75–89% | GOOD — Minor Attention Required | Address the flagged items within 7 days. No critical compliance risk. |
| 60–74% | MODERATE — Action Required | Schedule CAPA review with QA Manager. Address items within 48 hours. |
| Below 60% | CRITICAL — Immediate Action | Escalate to QA Manager and Plant Manager immediately. Do not schedule FDA inspection until resolved. |
Score ranges and category weights are configurable. Go to Settings → AI Compliance Config (/settings/ai-compliance-config) to:
BlisterCPMS includes a comprehensive notification system delivering real-time in-app alerts and configurable
email notifications for all critical events. Access your notifications via the bell icon in the navigation
header or via Notifications (/notifications).
| Event | Recipients | Delivery |
|---|---|---|
| Change order pending your approval | Assigned approver | In-app + Email |
| Approval deadline approaching | Assigned approver + their supervisor | In-app + Email |
| CO rejected — action required | CO creator | In-app + Email |
| CRITICAL deviation raised | QA Manager, Plant Manager | In-app + Email (urgent) |
| CAPA deadline approaching | Deviation owner, QA Manager | In-app + Email |
| Critical stock alert | Warehouse Manager, Change Parts Technician | In-app + Email |
| Part maintenance due | Assigned maintenance technician | In-app |
| Document expiring (30-day warning) | Document owner, QA Manager | In-app + Email |
| Work order QUALITY_HOLD | Production Supervisor, QA Engineer | In-app + Email |
| AI/GMP score dropped below threshold | QA Manager, Plant Manager | In-app + Email |
| Part reservation expiring | CO creator, Change Parts Technician | In-app |
| Tooling inspection due | Tooling technician | In-app |
Each user can configure their notification preferences in My Profile → Notifications. Options per event type:
All email notifications use configurable templates managed in Settings → Email Templates. Each template supports:
Part 5 covers Analytics & OEE, Reports & Exports, User & Role Administration, System Configuration, Backup & Recovery, and Master Data Administration. Open part5-analytics-admin.html to continue.
Overall Equipment Effectiveness (OEE) is the primary manufacturing KPI in BlisterCPMS. It is calculated per
work order using data from production records and displayed at multiple levels — per work order, per machine,
and plant-wide. Access via Compliance → OEE tab (/compliance).
Industry-leading pharmaceutical packaging performance. Achieved by top-quartile facilities.
Acceptable performance for most pharmaceutical packaging operations. Target for continuous improvement.
Significant losses occurring. Investigate top loss categories to identify improvement opportunities.
| Dashboard View | Location | What It Shows |
|---|---|---|
| Plant-Wide OEE | Dashboard KPI tile | Rolling 30-day OEE across all machines, displayed as a single percentage with month-over-month trend arrow |
| Compliance OEE Tab | /compliance → OEE tab |
Per-machine OEE trend by week/month, top loss categories (Availability / Performance / Quality), changeover time as % of planned production time |
| Work Order OEE Panel | Work Order detail page | Per-work-order A, P, Q values and final OEE score, calculated from production record data entered for that specific WO |
| Machine Performance Analytics | /machines/performance |
Per-machine OEE history, changeover frequency, MTBF (Mean Time Between Failures), MTTR (Mean Time To Repair) |
| OEE Loss Type | Root Cause (Common) | BlisterCPMS Action |
|---|---|---|
| Low Availability | Long changeovers, unplanned breakdowns, waiting for parts | Analyse changeover duration KPIs, check inventory alerts, review maintenance schedules |
| Low Performance | Running below rated speed, micro-stoppages, operator inefficiency | Review work order production records for speed data, compare actual vs. rated speed |
| Low Quality | High rejection rate, FAI failures, incorrect format installation | Review deviation records for this machine/product, check FAI trend, validate part compatibility settings |
The Reports module (/reports) provides analytics dashboards and export capabilities for regulatory submissions, management reviews, and operational analysis.
| Report Type | Description | Regulatory Use |
|---|---|---|
| Changeover Duration Report | Average, min, max changeover time by machine/product/CO type over selectable date range | Operational Excellence — KPI reporting |
| Part Inventory Report | Current stock levels, low-stock items, lot expiry list, last movement dates | Inventory audit, supplier performance review |
| Deviation & CAPA Report | All deviations by severity, type, status, overdue CAPAs, trend by month | FDA Form 483 preparation, QA management review |
| Audit Trail Export | Complete immutable audit log export for selected entity type and date range with integrity hash verification status | 21 CFR Part 11 audit package, regulatory inspection |
| E-Signature Report | All electronic signatures for a date range with signer, timestamp, action, and hash verification status | 21 CFR Part 11 compliance demonstration |
| Batch Record Package | Full electronic batch record PDF with linked CO, LOTO, line clearance, FAI, production data, and QA signatures | Batch release, regulatory submission support |
| OEE Summary Report | Plant-wide and per-machine OEE for selectable period with trend charts | Management review, continuous improvement |
| Tooling Lifecycle Report | Tooling set status, inspection history, reconditioning frequency, items approaching retirement threshold | Tooling qualification review, IQ/OQ/PQ audit |
| AI/GMP Audit Report | Current GMP compliance score with category breakdown, trend vs. previous audits, and recommendations | GMP readiness assessment, internal audit support |
| Part Traceability Matrix | For a given part number or lot number: all change orders and production batches it was used in | Recall investigation, adverse event tracing |
When exporting the audit trail in PDF format, the export itself is recorded as an audit event. The exported file includes a manifest page with the export timestamp, exporting user, hash of all included records, and a digital signature — ensuring the export cannot be altered without detection.
User and role management is restricted to System Administrators. Access via Settings → Users (/settings/users) and Settings → Roles (/settings/roles).
Click + New User. Fill in username, display name, email address, and set an initial password (user will be prompted to change on first login).
Select one or more roles for the user. A user can have multiple roles — they inherit the union of all permissions from all assigned roles. Choose the minimum roles needed for their job function (principle of least privilege).
For multi-site deployments, assign the user to their plant and branch. Users can only see data within their assigned site boundaries.
Check Send Welcome Email to dispatch the user's login credentials via the configured email template. The user receives their username and a temporary password.
| Security Feature | Default Setting | Configurable |
|---|---|---|
| Password expiry | 90 days | Yes — in System Configuration |
| Account lockout after failed attempts | 5 consecutive failures | Yes |
| Account lockout duration | 30 minutes (or until unlocked by Admin) | Yes |
| Session timeout | 8 hours | Yes |
| Concurrent session limit | 3 active sessions | Yes |
| Password minimum complexity | 8 chars, upper+lower+digit+symbol | Yes |
Custom roles can be created beyond the standard system roles. Access via Settings → Roles. For each custom role, assign the specific permissions needed. Standard permissions include:
System Configuration provides a centralised UI for managing runtime settings without code changes. Access via Settings → System Configuration (/settings/system-config). All changes are logged in the audit trail.
Global system parameters: session timeout, password policy, default alert thresholds, reservation expiry duration, FAI sample size default, OEE calculation periods.
Approval level rules by change type. Override default approval requirements (e.g., require L3 for all changes to a specific machine). Escalation timer settings.
SMTP server configuration (host, port, credentials, TLS/SSL). Sender name and from address. Test email delivery. Per-notification-type enable/disable switches.
Customise all notification email templates. HTML and plain-text editors with preview. Dynamic variable reference guide. Template revision history.
Database backup scheduling (daily/weekly), manual backup trigger, restore from backup, backup file list with creation timestamps and file sizes.
Configure AI audit scoring: category weights, score range thresholds, rolling window period, scheduled report generation frequency, notification recipients for score drops.
Regular database backups are critical for business continuity and regulatory compliance. BlisterCPMS provides a built-in backup management interface accessible to System Administrators only. Access via Settings → Backup & Recovery (/settings/backup).
Configure the backup schedule in Backup & Recovery. Recommended: daily full backup at 02:00 off-peak hours. Set the retention period (e.g., keep 30 daily backups, 12 monthly backups for 5-year regulatory retention).
Before any significant system change (software update, configuration change, bulk data import), trigger a manual backup using the Create Backup Now button. Wait for confirmation before proceeding.
Periodically test backups by performing a test restore to a non-production environment. BlisterCPMS records backup file hash — compare before and after restore to confirm integrity.
In the event of data loss or system failure: (1) Contact your IT infrastructure team to provision a clean environment; (2) Use the Restore from Backup function — select the most recent verified backup; (3) After restore, verify data integrity by checking the last audit log entry matches expected activity; (4) Document the incident and recovery in the system deviation record.
BlisterCPMS data (batch records, audit trail, e-signatures) must be retained for a minimum of 5 years under FDA 21 CFR Part 211. Ensure your backup retention policy covers this period. Off-site backup copies are strongly recommended for disaster recovery compliance.
Master data defines the reference tables used throughout BlisterCPMS. These must be correctly configured before the system can be used for production. Access all master data via Settings → Master Data sub-sections.
| Category | URL | What It Controls |
|---|---|---|
| Machine Models | /settings/machine-models |
Press and packaging machine model library (Uhlmann B1240, Syntegon GBK, etc.). Changeover templates are bound to machine models. |
| Format Sizes | /settings/format-sizes |
Standard blister format dimensions (e.g., "4×7 standard", "2×5 elongated"). Used in part/machine compatibility and changeover templates. |
| Pocket Sizes | /settings/pocket-sizes |
Standard pocket depth configurations for blister forming tools. |
| Blister Materials | /settings/blister-materials |
Forming film materials (PVC, PVDC, ALU-ALU, COC). Drives material-specific temperature settings in changeover templates. |
| Lidding Materials | /settings/lidding-materials |
Aluminium foil lidding specifications (push-through, child-resistant, peelable). |
| Product Families | /settings/product-families |
Product family groupings (e.g., "Analgesics", "Cardiovascular"). Used for reporting and analytics filtering. |
| Skill Levels | /settings/skill-levels |
Operator qualification tiers (OPERATOR, TECHNICIAN, ENGINEER) referenced in changeover template step requirements. |
| Production Lines | /settings/production-lines |
Physical packaging lines in your plant. Machines are assigned to production lines. Used in scheduling and conflict detection. |
| Shifts | /settings/shifts |
Work shift definitions (e.g., Day 06:00–14:00, Afternoon 14:00–22:00, Night 22:00–06:00). Used in production record time attribution and OEE calculations. |
| Currencies | /settings/currencies |
Currency definitions for part costing and inventory valuation. Set base currency and exchange rates. |
| AI Score Ranges | /settings/ai-score-ranges |
Customisable GMP audit score band definitions and associated colours/labels for the AI/GMP Audit display. |
| Categories | /categories |
Part category hierarchy used to organise and filter the parts master. |
| Locations | /locations |
Physical locations in your facility (buildings, rooms, storage areas). Linked to machines and parts for physical asset tracking. |
Deleting or modifying master data records that are in use (referenced by parts, machines, or change orders) will be rejected by the system with a referential integrity error. Never delete master data records that have history — mark them as INACTIVE or OBSOLETE instead to preserve audit trail integrity.
This section covers the most common issues encountered when using BlisterCPMS and their resolutions.
| Issue Type | Who to Contact | Information to Provide |
|---|---|---|
| Login / access issues | System Administrator | Username, error message, browser being used |
| Data entry / process questions | Your supervisor or QA team | Screen name, action attempted, what you expected vs. what happened |
| System performance / errors | IT team / System Administrator | Error message text, URL, time of occurrence, your username |
| Regulatory / compliance questions | QA Manager / Regulatory Affairs | Specific screen, specific requirement, relevant regulation section |
| System bugs / defects | IT team | Complete error message, steps to reproduce, time of occurrence, your username |
You have completed all 5 parts of the BlisterCPMS User Manual. This manual covers every module, workflow, and configuration option in BlisterCPMS Version 3.0.
For the latest updates, new feature releases, and correction notices, refer to the internal documentation repository.
| Document ID | UM-BCPMS-V3-P5 |
| Version | 3.0 |
| Date | April 30, 2026 |
| Authors | Product Management, Engineering Lead, QA Team |
| Status | APPROVED |
| Classification | Internal — Confidential |