PART 11 COMPLIANCE MODULE
Supports structured electronic records and signatures, audit trails, access, review and approval, and change history with consideration for FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.
Supports identification, retention, and retrieval of electronic records and electronic-signature workflows configured to project scope.
Supports traceability of defined system events and changes by time, user, and action context.
Supports role-based access, segregation-of-duties principles, account management, and risk-based CSV deliverables.
CONTROLLED BOUNDARIES
Functions and documentation consider relevant requirements, while actual application is configured to customer intended use and risk assessment.
The customer owns regulatory interpretation, SOP approval, account and infrastructure controls, training, PQ, and final validation acceptance.
Use of the product alone does not guarantee compliance with 21 CFR Part 11, Annex 11, or other regulations.
Final applicability and suitability require customer review and approval under approved procedures, risk assessment, and QMS.
BUSINESS INQUIRY
We define the implementation scope around your instrument environment, intended use, model operating approach, validation needs, and timeline.
Business Inquiry Paid PoC and implementation scope are confirmed through separate consultation.