PTC’s Product Development System (PDS) along with its NetRegulus software provides a single version of critical compliance data and documents for medical-device manufacturing. The software helps companies comply with 21 CFR Part 11 and 21 CFR Part 820, improve product quality and reliability by facilitating a risk-based approach to product design and validation, and easily manage and gather all product information necessary for audit requests including the design history files and device master records (DMR). In addition the PDS helps companies execute closed-loop change management which integrates CAPA requirements with the electronic content that must be modified, maintain a central repository for important records including SOPs, design files, and validation and qualification, documents.