Stay on top of regulatory documentation, batch records, and approval timelines without chasing scattered files.
Ensure all quality controls and production checksheets conform to Good Manufacturing Practices.
Track every batch release from initial QA audits to final certification in a central record.
Keep a detailed, electronic timestamp log of who completed and approved every process step.
Track DMF updates, license renewals, and import/export regulatory filing deadlines.
See how pharma teams run documentation, batch records, and approvals on Simplifyte.
Manage license renewals, pharmacovigilance, clinical trials, GMP audits, regulatory filings, product launches, and batch releases with status, period, financial year, and ownership in one board.
Open any task to see the client, financial year, period, due date, assignee, and task details together — so QA and regulatory teams know exactly what needs action.
Track batch records and quality checks with clear ownership, dates, and status so every production cycle has a consistent trail through completion and final sign-off.
Maintain a clear history of documents, approvals, and status changes so your team can trace who handled each action and when without rebuilding records later.
Handle leave, presence requests, and approvals through one queue with requester, remarks, and status visible — keeping workforce decisions moving during critical operations.
See attendance, late arrivals, overtime, and absences across production, QA, and regulatory teams in one view so shift coverage stays visible.
Reduce regulatory documentation errors by half
Track every approval and submission deadline in one place
Maintain inspection-ready audit trails automatically
Standardize batch record workflows across facilities
Cut time spent chasing sign-offs across departments
Join pharma teams who've brought clarity to regulatory documentation and approvals.
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