Many organizations today struggle to keep pace with the ever-increasing number of documents that flood into an organization including emails, quotes, invoices, specifications, and many other forms. A flexible PLM solution that includes on-line search, query and audit provides organizations with an opportunity to reduce waste, increase workflow, and maintain the security of important documents. Document management is also an important aspect of medical device manufacturing and after-market maintenance processes. Regulatory and compliance institutions mandate that all devices must include traceable documentation such as a design history file for the entire life of the product. In the event of a defect or recall occurs, the source of the problem can be quickly solved.
A document management solution includes the ability to quickly create, archive, trace, search and audit all documentation related to the manufacturing and service of a medical device product. This includes the product specification, testing procedures, technical reviews, risks assessments and phase reviews. Making sure that these documents are easily accessible and can be tracked easily is an important part of the regulatory compliance process. The capability to store and quickly search thousands of documents proves to be essential when trying to improve any business process. Document integrity is maintained by restricting access to sensitive items, and a full audit trail can be recorded to ensure integrity.