Compliant document management for pharma and life sciences
Meet 21 CFR Part 11 and ALCOA+ requirements with secure batch records, validation documents, and full audit trails.
Built for how pharma & life sciences teams actually work
From batch release to validation, pharma documentation has to be accurate, attributable, and ready for inspection at any moment. PraDocs gives QA and regulatory teams a single, compliant system instead of stitching together paper, spreadsheets, and shared drives.
- Electronic signatures that satisfy 21 CFR Part 11
- Data integrity controls aligned to ALCOA+ principles
- Faster batch record review and release cycles
- Validation documentation ready for any inspection
Everything Pharma & Life Sciences needs in one platform
21 CFR Part 11
Electronic signatures and access controls that meet FDA 21 CFR Part 11 requirements.
ALCOA+
Data integrity controls aligned to Attributable, Legible, Contemporaneous, Original, Accurate, and more.
Batch Records
Digitize batch records with version control and electronic review-and-release workflows.
Validation Documents
Manage IQ/OQ/PQ and validation protocols with full revision history.
“PraDocs cut our batch record review time by 60%. The audit trail alone justified the switch.”
Rina Kapoor
QA Director, PharmaCo
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Ready for inspection-ready document control?
See how PraDocs fits your team's workflow with a personalized walkthrough.