Quality ManagementQuality control and quality assurance in one place: protocols, sampling, results, deviations, CAPA, hold-time studies and water testing.
From the sample to the released lot: test protocols built from pharmacopoeial monographs, results checked against their limits, and every approval signed electronically by the right person - never the author.
Quality Management, in detail
Test protocols and specifications
Each material and product carries an approved test protocol, versioned with its effective date.
- Monograph library by material, product or general chapter, each verified by a second person
- Add the tests of a monograph to a protocol in one step
- The laboratory's method of analysis and data-sheet entries kept per test
- QA approval with an electronic signature before a protocol is used
Spec, MOA and ADS - written for you
The specification, method of analysis and analytical data sheet are generated from the approved protocol, so they always agree with it.
- Written by code from the approved protocol - never by a language model
- Filed in the document system under the protocol's own numbers
- Printable only after QA approval
- Every printed copy stamped and recorded
Sampling, testing and release
A goods receipt raises its sampling request; the analyst enters results against limits, and QA decides.
- Lots wait in quarantine and under test until a decision is made
- Results per test with pass / fail against the protocol's limits
- Certificate of analysis on approval; potency carried forward to dispensing
- Approved or rejected stock moved to its rack area - automatically or as a prepared move
Deviations and CAPA
Deviations are raised, investigated and closed with corrective and preventive actions.
- An open deviation blocks batch release and certificate approval
- Two-person acts: the person who raised it cannot close it alone
- Closure signed electronically
- CAPA actions land in each owner's inbox
Hold-time studies
Prove how long a bulk or intermediate may wait before the next step - and enforce it.
- Protocol approved and e-signed by QA, not by its author
- Pulls scheduled from the batch's release date and tested through the normal QC chain
- The report fixes the established hold from the pulls every batch passed
- Bulk past its hold is not offered for packing unless a deviation covers it
Water testing
Purified water, water for injection and potable water, sampled and trended by point.
- Sampling points with rotating schedules
- Tests and limits per water type
- Excursions recorded and followed up, missed samples flagged
- Trend charts per point and per test
Step by step
- ReceiptGoods receipt puts the lot in quarantine
- SamplingA sampling request is raised from the receipt
- TestingResults entered against the protocol's limits
- ReviewChecked by a second person
- DecisionQA approves or rejects with an e-signature
- ReleaseStock moves to the approved area, ready for use
Controls built in
- Electronic signatures on every approval, checked against the signer's password
- The author of a record cannot approve it
- Append-only audit trail of every change, with the reason for corrections
- Controlled printing with a copy log
On the roadmap
- Change control
- Market complaints and recall
- Stability studies
Not in the product yet - listed so you know where it is going.
Related modules
Document Management
Controlled documents and SOPs: versions, review and approval with e-signatures, editing in the browser, controlled printing and an append-only audit trail.
Learn more WMSWarehouse and Stores
Gate entry to dispensing: goods receipt into quarantine, stock moved by QC status, racks and areas, and material codes by grade and manufacturer.
Learn more MESProduction
Master formula and packing records, formula rules for potency and q.s., batch records checked against their master, and batch splitting.
Learn moreSee it with your own process
Open the live demo and look around, or talk to us about your plant.