Ardent Chemicals · 2025
Validated electronic batch records for Ardent Chemicals, with requalification as code
Paper batch records took 11 days to review and every software change meant six weeks of manual requalification. We built a validated electronic batch record system with requirements traced to 2,900 automated tests, cutting requalification to three days and batch review to 34 hours.
- Healthcare & Life Sciences
- 14 months
- 9 engineers, 1 validation lead, 1 designer
- 34 hours
- Batch review time, down from 11 days
- 3 days
- Requalification per release, down from 6 weeks
- 22 to 6
- Deviations raised per 100 batches
The challenge
What was wrong
Ardent's pharmaceutical intermediates line still ran on paper batch records. Review took 11 days a batch, and one missing initial sent the record back to the floor. Software replacing it falls under Annex 11 and 21 CFR Part 11, so every release needs requalification, and their previous vendor answered that with a six-week manual regression cycle. Weighing rooms also sit behind a network boundary that drops for a few minutes most weeks, mid-batch.
The approach
What we did
We traced every requirement to automated tests, 2,900 of them, and made the risk assessment machine-readable so a change reruns only the traced tests it touches. Requalification became a three-day job rather than six weeks. Audit trails are hash-chained per record in PostgreSQL, so tampering is detectable rather than merely prohibited by policy. Dispensing stayed on an offline-capable desktop client, which means two interfaces to maintain, because a dropped link must never pause a running batch.
“Our inspector asked how we requalify after a change. Showing the traceability matrix generated straight from the test run ended that part of the audit in ten minutes.”
Stack
What it runs on
- TypeScript
- NestJS
- React
- .NET 8 WPF
- PostgreSQL
- Playwright
- OPC UA
- Keycloak
Services
Practices involved
Engineering
Enterprise Software
Platforms for organisations with multiple entities, real auditors and a ten-year horizon.
Quality & Support
QA & Testing
A test suite you trust enough to deploy on, and small enough to run in eleven minutes.
Design
UI/UX Design
Research, interaction design and design systems for software people use every day.
Quality & Support
Cybersecurity
Threat modelling, identity hardening and detection engineering that finds real paths in.
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