Receive into quarantine
A posted goods receipt against an approved PO line creates a quarantine lot in a quarantine location and the first ledger entry.
- Approved PO line only
- CoA stored with integrity check
Supply moduleReceipt · quarantine · release
GMP warehouse management software — only released stock moves.
Swat iQua Suite controls every material lot from goods receipt to issue. Material arrives only through a posted goods receipt, lands in quarantine, is sampled and tested, and becomes usable only when QA releases it against the evidence — with an inventory ledger that can never be edited or go negative.
- Quarantine on receipt, against an approved PO
- 12 controlled lot statuses — illegal jumps refused
- Evidence-gated QA release, e-signed
- Identity always tested
Quarantine release
From goods receipt to usable stock.
Each status change is checked by the server. A lot cannot jump from quarantine to unrestricted without the evidence in between.
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Decide the testing level
Full, reduced or identity-only, based on the manufacturer site’s qualification and its run of conforming lots.
- Identity always tested
- Reset on OOS or deviation
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Sample and test
The approved sampling plan calculates the sample. Issuing it moves the lot to Under Testing and QC tests it against the specification.
- Approved sampling plan
- Calculation snapshot stored
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Release against the evidence
QA releases only with a conforming CoA, an identity result, all QC tests approved and no OOS.
- Receiver and analyst can’t release
- E-signed
Material status control
A warehouse that refuses the wrong move.
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12 controlled lot statuses
Quarantine, sampling pending, under testing, unrestricted, conditionally released, on hold, under investigation, retest due, expired, rejected, returned and destroyed.
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Only Unrestricted is issued
Only Unrestricted stock can be reserved or dispensed. Reservations stop the same stock being issued twice.
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Immutable inventory ledger
Every movement is a ledger row. Corrections are reversal rows, and the computed balance can never go negative.
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Locations and put-away
Warehouse and location masters, with the material types allowed in each location.
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Sampling plans
Versioned plans — formula-based such as √N+1, or fixed — approved by three different people. Each request stores its calculation.
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CoA integrity
CoAs and receipt documents are stored privately and checked with a SHA-256 hash on every download.
How it works
Pharma inventory with quality built into every move.
In a GMP warehouse, the status of a lot matters as much as its quantity. Material must be held in quarantine until it is sampled, tested and released, and only released material may be used. 21 CFR 211.84 requires components to be tested — with at least one identity test — before use, and EU GMP Chapter 5 sets similar expectations for starting materials. Swat iQua Suite makes those rules part of the system rather than a matter of labels and discipline.
Receipt and testing level
Material can only enter through a posted goods receipt against an approved purchase-order line, which is itself bound to an approved supplier source. The receipt creates a quarantine lot in a quarantine location. At the same time the system decides the testing level — full, reduced or identity-only — from the manufacturer site’s qualification and its record of consecutive conforming lots. The level resets after an OOS or deviation, and identity testing is always required.
Release and issue
QA material release is gated on evidence: a conforming CoA, an identity result, all QC tests approved and no open OOS. The person who received the material and the QC analyst who tested it cannot release it, and release is e-signed. Once Unrestricted, the lot can be reserved for a production order and dispensed. Every movement is written to an immutable ledger, so stock figures can always be reconstructed.
- Production Planning and MRP count only unrestricted, unreserved stock.
- Dispensing refuses any lot that is not Unrestricted.
- Distribution traces finished goods back to the material lots received here.
Designed to support compliance with
FAQ
Frequently asked questions
Can’t find your answer? Talk to our team — we reply within one business day.
Can material be used before QA releases it?
No. Only lots in Unrestricted status can be reserved or dispensed. A lot reaches Unrestricted only through an evidence-gated, e-signed QA release.
How does reduced testing work?
At receipt the system decides full, reduced or identity-only testing based on the manufacturer site’s qualification and consecutive conforming lots. An OOS or deviation resets it, and identity is always tested.
Can stock figures be edited?
No. Every movement is a row in an immutable ledger. Corrections are posted as reversal rows, and the balance can never go negative.
Who can release a material lot?
A QA user with the release permission who is neither the receiver nor the QC analyst on that lot. Release is e-signed.
How are sampling quantities calculated?
From versioned, approved sampling plans — formula-based (for example √N+1) or fixed. Each sampling request stores a snapshot of the calculation.
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