Order from a qualified source
A purchase order line can only use an approved, in-date source for that material.
- Quality agreement in force
- Valid GMP certificate
- PO approval e-signed
Follow one batchSupplier → shipment
Follow one batch from supplier to shipment.
Ten hand-offs, one record. See how Swat iQua Suite carries a batch of Paracetamol 500 mg Tablets from a qualified supplier to a shipped, traceable lot — and the controls the system enforces at every step.
- Only qualified sources in
- Only released stock out
- The person who ran the batch cannot release it
One connected flow
Ten steps. Every hand-off enforced.
Each step can only start when the one before it is complete and approved — the system checks, not a person with a clipboard.
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Receive into quarantine
The goods receipt creates a quarantine lot and decides the testing level — identity is always tested.
- Posted goods receipt only
- CoA stored with integrity check
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Sample and test
The approved sampling plan calculates the sample; QC tests the lot against its specification.
- Approved sampling plan
- Tests against the current spec
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QA releases the material
Release needs a conforming CoA, a passed identity test, every QC test approved and no open OOS.
- Receiver and analyst cannot release
- E-signed
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Plan and release the order
The production order locks the approved product, formula, process and specification versions.
- Feasible on released stock only
- Release e-signed by a second person
See this step in the product tour -
Dispense and verify
The bill of materials is scaled to the batch and weighed from released lots only.
- Calibrated scale
- Second-person verification
- Trained operators
See this step in the product tour -
Execute the batch record
Steps run in order with hold points and parameter limits. An out-of-limit reading raises a deviation — corrected, never overwritten.
- Hold points
- Training check per step
- Yield classified at close
See this step in the product tour -
Pack and reconcile
Bulk is packed within its hold time; printed components are reconciled before the finished lot is created.
- Bulk hold time
- Printed components balanced
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CoA and e-signed QA release
The release file is assembled from the records: batch record signed, QC complete, CoA generated, deviations and CAPAs closed.
- The person who ran the batch cannot release it
- E-signed
See this step in the product tour -
Ship and trace
Only released lots can be shipped. Any lot traces back to its raw-material lots and forward to every customer.
- Released stock only
- One-click traceability
See this step in the product tour
Traced in one click
Backwards to the raw material. Forwards to every customer.
The links are created by the work itself — not typed in afterwards — so a recall or an inspector’s question is answered from the records in seconds.
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Raw-material lot
Supplier, CoA, identity test and QA release.
Released -
Manufacturing batch
Dispensing records, steps, parameters and signatures.
Closed -
Finished-goods lot
Bulk, packaging order and reconciliation.
Released -
Shipment
Only to qualified customers, only released stock.
Delivered
A recall finds every affected lot and customer automatically — and closes with an e-signed evidence manifest.
At every step
The same four controls, all the way through.
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Audit trail
Every change, with old and new value, user, time and reason.
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Segregation of duties
Prepare, verify, approve and release are different people.
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E-signatures
Re-authentication at every approval that matters.
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Deviation & CAPA linked
Anything out of limit raises a record that stays linked to the batch.
Release
The release decision, built from evidence.
QA sees one release file per batch, assembled from the records themselves. Critical items cannot be marked “not applicable”, and the batch cannot be released while a linked deviation, OOS or CAPA is still open.
- Checklist filtered by product type and sterility.
- Blockers raised automatically by failed sterile checks and open records.
- Certificate of batch release generated on release.
FAQ
Frequently asked questions
Can’t find your answer? Talk to our team — we reply within one business day.
Do we need every module to follow a batch like this?
No. Start where you are — for example QC and release first — and connect the earlier and later steps as you add modules. Each phase is licensed only when it goes live.
What happens when a reading is out of limit?
The reading is kept, a deviation is raised from the step, and corrections supersede the original value without overwriting it. The release file cannot be completed while the deviation is open.
Can the same person dispense and verify?
No. Verification of dispensing, review of results and release decisions are enforced as separate duties, each confirmed with an e-signature.
How fast is traceability?
Any lot can be traced back to its raw-material lots and forward to every shipment and customer in one view, using the links created as the work was done.
Ready to see Swat iQua Suite in action?
Book a free, personalised demo and see how Swat iQua Suite takes your plants, labs and quality teams from paper to inspection-ready.