Pharma and Life Sciences

The quality records a regulated product needs, from specification to release, kept in one place.

For makers of medicines, nutraceuticals, diagnostics and medical products. Controlled specifications, a quality gate before release, change control, requirements traced to tests, and the audit trail that goes with them.

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What is inside

12 capabilities, each one a real screen.

Controlled specifications
Revisioned and approved, with limits and a test method per parameter, and the certificate of analysis generated from the results.
Batch release (QC)
A specification-driven release test and a gate: quarantined, pending, released or failed.
Batch genealogy and recall
Trace a batch forwards to customers and backwards to the lots it was made from.
Nonconformance, deviation and CAPA
Raise, contain, find the root cause, correct, verify and close, with an owner and a date.
Change control
Engineering change orders with a redline of what changed, and where it is used.
Requirements and verification
Trace a requirement to the test plan and the test run that proves it, for devices and diagnostics.
Document control
Lifecycle and approval for procedures and records, review reminders, retention and legal hold.
Supplier quality
Audits, certificates and test reports with the evidence file, and a verdict computed from them.
Calibration and maintenance
Gage and equipment calibration schedules, and preventive maintenance by date or meter.
Licences and pharmacovigilance
Manufacturing licences tracked to renewal, and adverse-event and clinical-study records.
Training records
Staff training recorded against the people who need it.
Controlled-area access
Visitor induction and NDA at the kiosk, host approval and an evacuation roll call.

Included in

Prabandh Suite

The pharmacovigilance, clinical-study and licence screens come from the regulated-products pack used by our Ayurveda customers. A conventional-pharmaceutical pack is planned and not yet released.

Part of the recommended set for: Pharma and Life Sciences.

Not included

Validated-system documentation and electronic-record and signature rules such as 21 CFR Part 11.
Unique device identification, serialisation and track-and-trace.
Cold-chain monitoring.
Direct capture of results from laboratory instruments.

We list gaps on purpose. If one matters to you, tell us in your inquiry.