DHF, DMR, DHR Management
Stay audit-ready and compliant with a structured approach to critical product documentation.
Our DHF, DMR, DHR Management module consolidates Design History Files, Device Master Records, and Device History Records into a single, well-organized system.
From initial design through final production, you’ll track every detail to ensure full transparency, traceability, and quality for regulated products.
Benefits
Unified Documentation Platform
Keep design and manufacturing records in one secure location, accessible to authorized stakeholders
Version & Revision Control
Maintain clear records of every change to designs, processes, or test results, essential for audits and investigations.
Design Control & Milestones
Track each phase of product development—from concept approval to final validation—ensuring complete documentation.
Traceability Links
Connect design data (DHF) to master records (DMR) and each manufactured batch’s history (DHR) for end-to-end visibility.
Regulatory Alignment
Comply with stringent standards like FDA 21 CFR Part 820 or ISO requirements, demonstrating robust documentation practices.
Change & CAPA Integration
Link design or production modifications directly to CAPA or ECO modules when addressing quality or regulatory issues.
What Sets Us Apart
By centralizing DHF, DMR, and DHR activities, our module ensures that no vital piece of documentation falls through the cracks.
Audit trails, revision history, and linked compliance checks empower your teams to operate transparently, address concerns swiftly,and bring high-quality products to market with unwavering confidence.
Why Choose PLM?
Enhances traceability
Ensures audit readiness
