Inventory in sterile manufacturing is more than counting stock.
A material may be physically available but still unavailable for production.
Under quarantine
Physically present in warehouse but locked pending initial verification.
Awaiting QC release
Analytical testing under way; certificate of analysis (COA) not yet issued.
Expired or approaching expiry
Surpassed shelf life or retest limit and blocked from batch compounding.
Allocated to another batch
Reserved against an active manufacturing order to prevent double-dispensing.
Stored in the wrong location
Stored outside authorized cleanroom zone or designated bin.
Subject to specific storage conditions
Cold-chain, humidity, or sterile atmospheric parameters require validation.
Part of a specific supplier lot
Vendor lot holds or site-level quarantine restrictions applied.
Built around the realities of sterile manufacturing
Sterile manufacturing leaves little room for uncertainty around materials.
The system helps teams maintain visibility across material status, lot numbers, expiry, storage locations, quantities, and movement history — so warehouse, QA, QC, and production teams are working from the same information.
Material Receipt & Quarantine
Barcoded receipt against supplier PO & lot. Auto-quarantine lock.
Sampling & COA Upload
Direct lab verification. Passing test results linked to lot status.
Part 11 Electronic Release
Digital e-signature clearance unlocking lot for production dispensing.
Cleanroom Dispensing & eBMR
Barcoded verification before issuance to sterile compounding suite.
One view of your material inventory
See what is available, what is blocked, what is under testing, and what has already been allocated — without relying on spreadsheets, registers, or manual reconciliation.
Every material has a status.
No ambiguous inventory. State flags clearly demarcate Quarantine, QC Released, Allocated, or Expired.
Every movement has a record.
Complete auditable trail capturing operator ID, timestamp, source rack, and target bin for every movement.
Every lot has a history.
Full vendor-to-batch genealogy detailing receipt date, COA reference, storage location, and batch consumption.
Core workflows
Click through each core workflow below to explore the step-by-step GxP execution steps.
01. Material Receipt & Dock Quarantine
Record incoming raw materials, packaging, components, and consumables against supplier PO, manufacturer lot number, quantity, and expiry. Incoming goods immediately locked in quarantine status.
Goods Arrival
Scan supplier PO barcode and record physical container count at warehouse dock.
From supplier lot to manufacturing batch
When a material is used in production, you should be able to answer:
Origin
Where did it come from? Supplier invoice, PO barcode, and vendor COA records permanently linked.
What changes for your team?
Stop searching through registers and spreadsheets to understand current stock.
Get clear visibility into material status and release conditions.
Know whether the materials required for a batch are actually available for use.
Get a reliable view of inventory across materials, locations, and statuses.
Make every material movement visible.
Give your sterile manufacturing team one reliable system for knowing what is available, what is released, where it is, and where it went.
See the Inventory Management System →Frequently Asked Questions
How does QA Stack IMS enforce quarantine control?
Materials automatically enter a locked Quarantine status upon receipt entry. The system blocks dispensing or issuance until QC enters a passing COA and QA performs a Part 11 e-signature release.
Is QA Stack IMS compliant with 21 CFR Part 11 and CDSCO?
Yes. Every material movement, status change, and dispensing transaction records an immutable audit trail with operator ID, timestamp, and e-signature verification.
Can IMS integrate with existing ERP systems like SAP or Tally?
Yes. QA Stack IMS supports bi-directional API integration for sync of purchase orders, vendor lots, and stock consumption.