PLM & Product Compliance
Product compliance, engineering change, requirements traceability and product quality across the lifecycle.
4 articles
- Design Traceability Matrix Template for Medical Devices (QMSR and Software) Build a design traceability matrix that links user needs, inputs, outputs, V&V and risk controls, aligned with QMSR and FDA's 2023 software guidance.
- Requirements Traceability for Medical Devices: Building a Traceability Matrix Auditors Trust Build requirements traceability that FDA and auditors trust: what ISO 13485, FDA software guidance and IEC 62304 expect, matrix structure and AI checks.
- Design Control Software and DHF Automation: What to Automate and How to Validate It What design control software should automate under the QMSR, where AI helps, how to validate tools under FDA's CSA guidance, and a selection checklist.
- Change Control Software: What It Must Do, How to Validate It and How to Choose What GMP change control software must do, the Part 11 and Annex 11 controls it needs, risk-based validation and the questions to ask vendors.
Subjects covered
- product lifecycle management
- PLM software
- PLM compliance
- product compliance software
- product quality management
- product quality assessment
- product risk management
- product compliance management
- engineering change management
- engineering change assessment
- product development compliance
- product documentation management