The challenge
Regulatory documentation prep for filings and inspections was a multi-week effort per submission, with batch records, deviation logs, and analytical data manually stitched into narrative form. Any AI assistance had to be defensible under FDA 21 CFR Part 11 and Schedule M, which ruled out anything without immutable signing.
How we approached it
Ajuni put Pragna on regulatory documentation drafting against Cipla's LIMS and document-management system, and Veer signed every artefact into a tamper-evident store with reviewer identity baked in. The deployment ran inside Cipla's existing Azure India tenant with full corpus retention controls.
Outcomes in production
- Report-pack turnaround compressed to 14 minutes
- Zero compliance failures across review cycles
- FDA-ready signed audit trail per artefact
- Reviewer time freed for higher-judgement work
- 12 weeks kickoff to production drafting
Stack & guardrails
Integration & deployment
- Azure India · Cipla tenant
- LIMS integration · batch data
- DMS connector · SOPs
- Claude Sonnet 4 · API
- Tamper-evident signing store
- Power BI quality mirror
Compliance & audit
- FDA 21 CFR Part 11
- Schedule M (India)
- DPDP Act 2023
- WHO-GMP audit posture
Timeline
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Week 0–2
QA + reg scoping
Document set and signing scheme designed with QA and regulatory teams.
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Week 3–5
LIMS + DMS wiring
Pragna integrated with batch data and SOP corpus under read-only scope.
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Week 6–9
Shadow drafting
Agent drafted alongside reviewers; deviation logs cross-checked daily.
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Week 10–12
Compliance review
Signed audit trail walked through with internal compliance before cutover.
