Approve the formula and process
Batch size, bill of materials with target, minimum and maximum quantities, theoretical yield window and ordered process steps.
- Preparer ≠ reviewer ≠ approver
- One approved version at a time
Oral solid dosageTablets · capsules
Oral solid dosage manufacturing software from approved formula to released lot.
Swat iQua Suite gives tablet and capsule plants one controlled record from the master formula to the shipped finished-goods lot — verified dispensing, a step-by-step OSD eBMR, printed-component reconciliation, in-house QC and evidence-based QA release.
- Approved, version-locked formulas
- Dispensing from released lots only
- Packaging reconciliation before completion
- E-signed release with SoD
One batch, end to end
How a tablet batch moves through Swat iQua Suite.
Each hand-off below is enforced by the system — a step cannot proceed until the one before it is complete, signed and within limits.
-
-
Release the production order
The order snapshots the approved versions and checks material feasibility against unrestricted, unreserved stock only.
- Named blocker list on screen
- Shortage needs an approved exception
-
Dispense and verify
The BoM is scaled to the batch; gross, tare and net are captured and reconciled against the min/max window.
- QA-released lots only
- Uncalibrated critical scale blocked
- Verifier ≠ dispenser
-
Execute the batch step by step
The steps you define in the process master — for example granulation, blending, compression and coating — run with recorded parameters and verifications.
- Hold points
- CPP limits raise deviations
- Training interlock
-
Pack and reconcile
Released bulk becomes finished-goods lots under an approved pack configuration, and printed components must balance.
- Issued − used − returned − destroyed
- Discrepancy needs QA e-signature
-
Test against the specification
Tests come from the effective specification; limits are frozen at assignment and each result is classified within limits or OOS.
- Instrument must be in calibration
- Reviewer ≠ analyst
-
Release with e-signature
The release dossier checks the batch record, yield, QC, CoA, deviations and packaging reconciliation before QA signs.
- Batch executor ≠ QA releaser
- Critical items cannot be N/A
Why OSD plants digitise
Fewer batch-record errors, fewer surprises at release.
Formulation plants run many products, many batch sizes and many batches a week. On paper, the errors that matter are small and repetitive — and they surface at the worst moment, during review or release.
The right formula version, every time
A batch can only be created from a released production order, and it snapshots the exact approved product, formula, process and specification versions. There are no live look-ups that change mid-batch, and an old master cannot be picked by mistake. A new formula version is approved by three different people and supersedes the previous one automatically.
Dispensing that cannot use the wrong lot
Only lots QA has released to unrestricted status can be weighed — quarantined, under-test, on-hold and rejected lots are refused. The calibration status of each scale is taken from Instrument Calibration & Maintenance, and an uncalibrated critical scale is blocked. Whether a weight was keyed in manually or came from the instrument is recorded, and a second person verifies every weighing with an e-signature.
In-process limits that raise their own deviations
Critical parameters are checked against their minimum and maximum as they are entered. An out-of-limit reading raises a deviation from the step, and corrections supersede the original value instead of overwriting it, so the reviewer sees what happened and why.
Paper where you still need it
Not every line goes paperless on day one. Hybrid batch records give each paper copy a controlled-copy number and a one-time print fixed with a checksum; the copy must be reconciled or archived before the batch can close.
Bulk hold time and printed components
Bulk from a completed batch is held within its hold-time window — an expired hold blocks QA approval. At packaging, issued, used, returned and destroyed labels, cartons and leaflets are reconciled, and the order cannot complete until the count balances or QA approves the discrepancy with an e-signature.
Batch numbers are built from your own segments — product code, dosage form, year, sequence and an optional check digit — and a voided number is never reissued.
QA release
Release decisions built on evidence, not on chasing paper.
Each batch gets one release dossier, built from a versioned checklist. QA can release only when every critical item is satisfied — and the system checks the linked records itself.
- Linked-record checks — “QC complete” and “deviations closed” cannot be ticked while linked QC, deviation, OOS or CAPA records still block.
- Documented overrides — an exception needs a risk-acceptance request and an independent, e-signed approval.
- SoD on release — the person who executed the batch can never release it.
- Certificate of Batch Release — an A4 PDF, with finished-goods lots moved from quarantine to released.
Around the line
Everything else a formulation plant needs on the same platform.
-
GMP warehouse
Goods receipt into quarantine, evidence-gated QA material release and an immutable inventory ledger.
GMP warehouse -
Specifications
Versioned product and material specifications with test-method trees and alert and action limits.
Specification management -
Stability studies
Pull schedules computed from time zero per storage condition, with ICH Q1E regression and shelf-life reporting.
Stability studies -
Continued process verification
Mean, Cp and Cpk with ±3σ control limits, computed from the data points you record per product and parameter.
CPV -
SOP-linked training
Operators trained on an SOP before the step that needs it — the eBMR checks it at step start.
Training management -
Deviation & CAPA
Shop-floor deviations raised at the step flow into one CAPA register, tracked to effectiveness.
CAPA management
Compliance
Batch records an inspector can read in minutes.
US cGMP requires a batch production and control record for every batch (21 CFR 211.188), and production records to be reviewed — with any unexplained discrepancy investigated — before release (21 CFR 211.192). EU GMP, WHO GMP and India’s Revised Schedule M set out the same principles: records made at the time of each action, by identified people, against approved instructions, with deviations investigated.
The Executed Batch Record PDF from Swat iQua Suite lists every step, parameter and correction, every signer, every linked deviation and attachment, and the full audit trail — and each print is logged. Because the release dossier checks linked deviations, OOS results and CAPAs itself, unexplained discrepancies cannot be released by oversight.
Swat iQua Suite is designed to comply with 21 CFR Part 11, EU GMP Annex 11, WHO GMP and Revised Schedule M, following ALCOA+ data-integrity principles and a GAMP 5 risk-based validation approach.
FAQ
Frequently asked questions
Can’t find your answer? Talk to our team — we reply within one business day.
Can we model our own tablet and capsule processes?
Yes. Process steps are defined in versioned process masters with operation type, criticality, instructions and flags for verification, signature, attachment and hold points. Each batch expands the approved steps into its own record.
Do we have to go fully paperless from the start?
No. Hybrid batch records keep controlled paper copies alongside the electronic record, and the batch cannot close until each copy is reconciled or archived. Many plants move line by line.
Does the system print labels or serialise packs?
No. Packaging in Swat iQua Suite controls pack configurations, bulk reservation and printed-component reconciliation. Label printing and serialisation stay with your existing packaging-line systems.
How is yield handled?
Yield is captured at batch close and classified against the yield window set on the approved formula, and “yield reconciled” is an item on the batch release checklist.
Can operators start a step they are not trained for?
No. A step cannot start unless the operator is trained on the SOPs linked to it. Dispensers, verifiers and packaging staff are checked the same way.
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.