Historically, traditional stand-alone QMS systems have addressed only a subset of information necessary to comply with quality regulations imposed by the FDA and other regulatory bodies like ISO and EMA. These solutions have been constrained because they provide a document-centric approach to manage quality, training, and, in some cases, even product design information.
These document-centric QMS systems have focused on only two key areas of FDA quality compliance:
- Documentation control for standard operating procedures (SOPs), specifications, and other files
- Process enablement and tracking for auditable processes, including CAPA and training records
Most of these QMS systems simply provide automation of paper-based processes and consequently fail to manage the complete product record comprised of mechanical, electrical, and software components; assembly and test procedures; and other documents specified in the multilevel BOM. Some QMS software providers claim to provide BOM management capabilities, but typically provide flat, nonhierarchical BOMs as references in documents. A key limitation of this approach is it requires manual data entry in planning and production systems as the design moves into production and full commercialization (e.g., ERP systems). This results in delays throughout the new product introduction (NPI) process and potential errors whenever new changes are introduced to the design.
For sophisticated medical device companies, having relational, hierarchical BOMs is essential to define and control the entire product structure from the top-level finished good all the way down to the lowest level of the assembly. Relational BOMs provide the complete “recipe” necessary to plan, source, and build high-quality devices that work as designed. Arena QMS comes with a comprehensive BOM management solution that “speaks the same BOM language” from early CAD design through prototyping and into final production by enabling the seamless passing of BOM information from one system to another.
While control of quality processes is essential in the medical device industry, a document-centric approach may suffice for some life sciences companies (e.g., pharmaceutical, hospitals, services) that do not create and manufacture a discrete medical device product comprised of electrical, mechanical, and/or software components. Medical device manufacturing companies are required to carefully track, control, and release product design changes to market quickly and effectively.