"There has been a lot of confusion about eDiscovery and how a record is defined in the life sciences industry – some organizations believe that regulated content is the only content that has to have record classifications applied to it, which isn’t the case. Additionally, because of the litigation aspects associated with these records, legal counsel and the senior executives bring their own perspectives.
Pharmaceutical, biotechnology and medical device manufacturers face a vast amount of legislation and regulation which guides 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.
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."