Document management is essential for any organization, but none more than the medical industry. Documents and records serve as proof that your medical device company uses compliant document management practices when designing, developing, and manufacturing health industry products. Quality Digest brought this news to our attention in their article, “Top Three Document Management Tips for Medical Device Companies.”
The FDA and other regulatory officials are watching, and documentation gives you insurance that what you say happened, happened. So pay particular attention to the kinds of documented evidence you’ll need to demonstrate that you’ve carried out the various quality management system activities according to planned arrangements.
A strong document management system integrates records management, which allows seamless compliance with records retention guidelines. Any records management system requires a system of indexing to create findability. We know that indexing against a strong, standards-based taxonomy can ensure comprehensive search results. Access Innovations is one of a very small number of companies able to help its clients generate ISO/ANSI/NISO compliant taxonomies to produce such comprehensive results.
Melody K. Smith
Sponsored by Data Harmony, a unit of Access Innovations, the world leader in indexing and making content findable.