Walk into any life sciences organization and you might see more than a few people scratching their heads and looking bewildered when asked about eDiscovery and how exactly a record is defined in the industry.

Pharmaceutical, biotechnology, and medical device manufacturers face an enormous number of regulations, including the FDA Rule: 21 CFR Part 11 for Electronic Records and Electronic Signatures, which guide their records management practices. Records Management is nothing new to this industry, but the increasing use of technology in the industry, and the increasing use of electronic information management, is forcing organizations to rethink the way they manage their records.

In a recently released podcast, Open Text discussed these issues with Christine Ardern, Director, Records Management for Entium Technology Partners, LLC, and Liz Kofsky, Records Management Program Manager for Open Text.

Stressed in the podcast, the fact that organizations need to recognize that a solid enterprise-wide records management practice is essential to a successful compliance program. Many organizations have implemented departmental strategies to address one or more records management requirements typically under the regulatory or quality management umbrella, but recent changes in eDiscovery legislation as well as general good corporate governance practices require a holistic approach to records management.

The main thing to remember is that keeping everything is not a viable option - the podcast will help you take the first step in determining the best records management options for your organization.