Make FDA and ISO compliance a breeze.
For customers in medical device and other highly regulated industries, BOMControl enables worry-free compliance with standards like ISO 13485.
Everything in one place: The Device Master Record.
To ensure medical device compliance, the Device Master Record (DMR) should capture every part, drawing, document, work instruction and processing instruction related to your medical device.
Our BOM Management functionality is designed for precisely this purpose, creating a clear and consistent product record with robust version control that is centralized and accessible as needed, rather than distributed across your supply chain and engineering team.
The big picture: The Design History File.
Detailed documentation of the evolution of your product through the design and manufacturing process is a key part of medical device compliance. The Design History File (DHF) captures the complete record of your design decisions from the planning phase to the inevitable changes during manufacturing. Whether you organize your DHF by BOM or by phase of production, BOMControl’s built-in change management processes help you document each key decision.
Traceability at every step of the process: 21 CFR, Part 11 Compliance.
Managing electronic signatures is key for FDA compliance. Our two-token password system ensures secure access control, and our electronic signature template makes it easy for you to educate employees on the key features of 21 CFR, Part 11 compliance. With complete integration into the change management functionality in BOMControl, each step in your design project is tracked and documented as required by the FDA.
Maintain full validation with on-call support from our validation experts.
Our unique Validation Maintenance Service (VMS) offers you complete impact analysis on all software updates, a complete series of validation tests and test results, and an official validation certificate. Arena documents validation maintenance for you, and delivers the validation documents right in the BOMControl application, saving you weeks of effort. As part of the VMS, you are entitled to a guaranteed half-day audit of Arena, as well as unlimited on-call support from our validation experts when you are audited. Contact us today to learn more
Validation Maintenance Service Add-on
- Complete initial validation templates
- Release-by-release validation records
- On-call validation support