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Solution · Pharmaceutical document control
GxP document management for pharmaceutical and biotech operations
Pharmaceutical and biotech teams need more than file storage—they need document control that survives inspection: authoring, review, approval, controlled issuance, training gates, and retirement with ALCOA+ audit trails. Novaqis DMS delivers the full lifecycle on the same platform as LMS retraining and QMS change control, deployable on-premise in validated environments.
Product preview
Approval queues, effective documents, and operational visibility
Dashboard / Dashboard
Dashboard
Documents by type
Count of documents per document type
Status distribution
Share of documents by workflow status
Needs your action
Tasks sorted by deadline — overdue first
Capabilities
Author in the browser with track changes, comments, check-out/check-in, and version compare with e-sign restore. Route through workflows and change control with entity audit trails aligned to 21 CFR Part 11 and EU Annex 11 validation narratives.
Copy-numbered controlled copies with watermarking, pantograph security, microtext borders, crypto QR verification, and geo-fenced print stations. Live issuance register, recall workflows, and destruction requests with approver signatures.
Block secure view, print, or issuance until LMS qualification is verified for the document type or assignment. Training evidence and document access share one identity model—no monthly reconciliation between systems.
Summarize long SOPs, flag spelling and grammar issues, and assist during review—all permission-gated with human sign-off unchanged. Deployable on your network without mandatory public-cloud inference.
Admin-integrated migration tooling with connection test, dry-run, and execute phases—traceable cutover from incumbent platforms instead of manual re-keying and shadow file shares.
Document effective dates drive LMS assignments automatically. When SOPs change, competency updates on the same stack as the controlled record—investigators see training status beside document versions.
Outcomes
