GMP-Compliant · 21 CFR Part 11 · Version 3.0

Change Parts Management
Built for Pharma.
Designed for GMP.

BlisterCPMS unifies blister, cartoning and tablet tooling change parts into one GMP-compliant enterprise platform — eliminating paper, accelerating changeovers, and ensuring full regulatory traceability.

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21 CFR Part 11

EU GMP Annex 11

On-Premise or Cloud

Zero Spreadsheets

BlisterCPMS — Global Dashboard

📉

−45%

Avg. changeover time

45%

Average reduction in line changeover time using guided digital checklists and pre-validated part kits

100%

Digital records — all documentation is electronic, time-stamped, and tamper-evident from day one

21 CFR

Part 11 full compliance — every action is electronically signed, logged, and cryptographically secured

20+

Integrated modules across three packaging domains sharing one audit trail and analytics engine

Three Packaging Domains

One Platform. Complete Coverage.

Full lifecycle management for every packaging domain — blister primary packaging through secondary cartoning to tablet compression tooling.

Primary Packaging · Domain 01

Primary Packaging,
Fully Controlled

Complete lifecycle management for blister change parts — forming tools, sealing jaws, guide plates, and format parts. Every movement tracked, every maintenance scheduled, every compatibility validated.

›7-tab inventory: Critical, Low Stock, Expiring, Reorder, Maintenance, Analytics
›Machine-level OEE monitoring with drill-down analysis
›Product–machine–part 3-way compatibility matrices
›Predictive maintenance based on runtime & lifespan data
›Lot & serial number traceability with full movement history

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Secondary Packaging · Domain 02

Secondary Packaging,
Line-Ready Always

Real-time production line status, patient information leaflet management, carton specification version control, and pre-batch line readiness verification — all in one view.

›Live production line dashboard per line with real-time status
›Patient Information Leaflet (PIL) version control
›Carton specification sheets with product linkage
›Line readiness: parts, leaflets, cartons verified before batch
›Installed parts tracking and change order integration

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Compression Tooling · Domain 03

Compression Tooling,
Every Lifecycle Stage

Full lifecycle management for TSM, EU, and IPT tooling sets — from initial registration through inspections, reconditioning, and retirement. Dashboard alerts before failures occur.

›Tooling sets: TSM / EU / IPT standards
›Individual item tracking — punches & dies
›Inspection records with pass/fail, measurements, photos
›Reconditioning history with cost and vendor tracking
›Dashboard & proactive lifecycle alerts

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Platform Capabilities

20+ Integrated Modules.
Built In. No Add-Ons.

Three packaging domains — one authentication layer, one compliance engine, one analytics core. No third-party integrations needed.

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Shared

Change Orders

8-tab lifecycle: Active, Pending, Approved, Overdue, Templates, Part Kits, Analytics. Multi-stage approval with electronic signatures.

🛡️

Shared

GMP Compliance

7 tabs: OEE, Audit Log, Deviations/CAPA, FAI, LOTO, Batch Records, AI Audit Scoring. Immutable 21 CFR Part 11 audit trail.

🧩

Blister

Parts Inventory

7-tab inventory with lot & serial tracking, expiry alerts, reorder automation, maintenance scheduling, and analytics.

🔧

Shared

Work Orders

Full work order lifecycle: create, assign, schedule, execute, close. Batch creation, template-driven flows, SLA tracking.

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Shared

Global Dashboard

6 real-time views: Overview, Operations, Inventory, Machines, Analytics, Executive. One command centre.

📈

Shared

Analytics & Reports

6 report types: Executive, Change Orders, Inventory, Machine Performance, SLA & Compliance, Supplier Performance.

🗺️

Shared

Warehouse & Locations

6-tab location management: Utilization, Hierarchy, Temperature zones, Capacity, Analytics. Multi-location tracking.

🏭

Blister

Blister Machines

Complete machine lifecycle: status monitoring, OEE trending, maintenance history, installed parts, benchmarking.

⚙️

Admin Only

System Settings

19 configuration sections: users, roles, master data, AI scoring config, workflow rules, email templates, backup & recovery.

System Screenshots

See the Platform in Action

A purpose-built interface designed for pharmaceutical manufacturing — minimal clicks, maximum clarity.

Overview

Analytics

Machines

Executive View

Active Orders

Create Order

Pending Approval

Line Clearance

Overview

OEE Dashboard

Audit Log

AI GMP Audit

Parts Inventory

Tablet Tooling

Blister Machines

Reports

GMP Compliance Centre

Inspection-Ready.
Every Day.

Designed from the ground up for regulated pharmaceutical manufacturing. Every module enforces GMP discipline — so your site is always ready for FDA, EMA, or any national regulatory authority.

21 CFR Part 11EU Annex 11GMP Annex 15ISO 9001GAMP 5

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✍️

Electronic Signatures

Reason-based e-signatures with identity confirmation — 21 CFR Part 11 compliant

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Immutable Audit Trail

Cryptographically hashed log of every data change — accessible to regulatory inspectors

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Deviation & CAPA

Full deviation register with root cause investigation, CAPA assignment and effectiveness verification

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First Article Inspection

FAI records after every changeover — measurements, inspector sign-off, conformance outcome

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LOTO Management

Lockout/tagout energy isolation records with personnel log and electronic clearance

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AI GMP Audit Score

AI-driven risk scoring across all compliance activities with configurable thresholds and alerts

How It Works

From Plan to Archive — Fully Audited

A structured, GMP-enforced changeover lifecycle. Every step signed, every decision time-stamped, every record permanently archived.

Create Order

Select machine, product & template. System auto-populates parts and validates 3-way compatibility.

Approval Chain

Routed to approvers with email alerts. Each sign-off electronically recorded with reason and timestamp.

Line Clearance

LOTO performed, previous product removed, digital checklist completed, line clearance signed.

Execute & FAI

Changeover executed with real-time guidance. First Article Inspection confirms conformance.

Close & Archive

Order closed, duration logged. Audit trail and batch record auto-generated and archived.

Access Control

Role-Based Permissions — Granular by Design

Three default roles with fully configurable permissions per user. Administrators tailor access to every feature module.

Administrator

🛡️

System Admin

Full unrestricted access including System Settings

✓All module read + write access
✓User management & role assignment
✓19-section System Settings
✓AI score & workflow configuration
✓Backup & recovery operations
✓Master data administration

Production Manager

👷

Prod. Manager

Elevated operational access — no System Settings

✓Create & approve change/work orders
✓Manage templates & part kits
✓Performance analytics & all reports
✓Tooling reconditioning write access
✓Bulk work order batch creation
✗System Settings (Admin only)

Standard User

👤

Operator / Technician

Granular permissions configurable per feature area

✓View dashboards & reports
✓Execute assigned orders & checklists
✓Record stock movements & adjustments
✓Upload & view documents
✗Approve change orders
✗Analytics tabs (configurable per user)

Licensing & Pricing

Transparent Pricing for Every Scale

All tiers include full GMP compliance features. No hidden module fees. Price scales with facility size.

Starter

Single Site

$4,800/yr

Per facility · up to 25 users

Ideal for small to mid-size facilities with one production site and a single packaging domain.

✓1 packaging domain
✓Up to 25 named users
✓Full GMP & 21 CFR Part 11
✓Change orders & work orders
✓Audit trail & e-signatures
✓Email support · 5 business-day SLA

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On-premise or cloud deployment

Stop Managing Change Parts on Spreadsheets.

Deploy BlisterCPMS on your facility network and start reducing changeover time, eliminating paper, and achieving full GMP compliance — in weeks, not months.

📖 Read User Manual ✉️ support@quantumassists.com 📞 +91 99872 72169

GMP Compliant — 21 CFR Part 11 & EU GMP Annex 11

On-premise or cloud — Docker-ready in hours

Full audit trail from day one

IQ/OQ validation documentation available

Request a Demo

A product specialist will respond within 1 business day.

Change Parts ManagementBuilt for Pharma.Designed for GMP.

One Platform. Complete Coverage.

Primary Packaging,Fully Controlled

Secondary Packaging,Line-Ready Always

Compression Tooling,Every Lifecycle Stage

20+ Integrated Modules.Built In. No Add-Ons.

See the Platform in Action

Inspection-Ready.Every Day.

From Plan to Archive — Fully Audited

Role-Based Permissions — Granular by Design

Transparent Pricing for Every Scale

Stop Managing Change Parts on Spreadsheets.

Request a Demo

Change Parts Management
Built for Pharma.
Designed for GMP.

Primary Packaging,
Fully Controlled

Secondary Packaging,
Line-Ready Always

Compression Tooling,
Every Lifecycle Stage

20+ Integrated Modules.
Built In. No Add-Ons.

Inspection-Ready.
Every Day.