Electronic Records & Signatures
Achieve full 21 CFR Part 11 and EU Annex 11 compliance with validated electronic records and signatures. Provide tamper-evident audit trails, user authentication controls, and system access management that satisfy the most rigorous regulatory expectations.
Key Features
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Related Modules
Document Control
Manage the entire lifecycle of quality documents with version control, electronic signatures, and automated workflows. Ensure every SOP, work instruction, and form meets regulatory requirements with a fully auditable document management system built for medical device compliance.
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Ensure every team member is qualified and current on required procedures with automated training assignments and competency tracking. Maintain a complete training matrix that satisfies ISO 13485 competence requirements and FDA expectations.
Design Control
Manage the complete design and development lifecycle from user needs through design transfer. Maintain full traceability between design inputs, outputs, verification, and validation activities as required by FDA QMSR and ISO 13485.