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.
Key Features
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Related Modules
Audit Management
Plan, execute, and track internal and external audits with configurable checklists and finding management. Generate audit reports automatically and ensure every observation is linked to corrective actions for complete regulatory traceability.
Training Management
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.
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.