Let My Records Go: Unleashing Inactive Records From Documentum

When Documentum came to market more than 20 years ago, the timing was fortuitous. In 1997 the FDA issued 21 CFR Part 11, its rule dictating requirements for managing electronic records and the use of electronic signatures in pharmaceutical companies, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries.

The result was that thousands of companies suddenly needed a way to ensure that electronic documents were tracked and managed with functionality that controlled access, included an audit trail and included an electronic signature capability. Many of those companies selected Documentum as a platform for building custom solutions to manage electronic documents ranging from quality documents and manufacturing records to eTMF content relating to drug trials and the content that goes into new drug applications (NDAs).