Gaining A Complete View Of Regulatory Activity

Life Sciences organizations must keep current, complete records of all documents and communications associated with the drug applications submitted to regulatory agencies—both directly and through their affiliates. This means you need to keep complete records of exactly what was submitted for each market where you have applied to conduct business, including related communications such as emails, meeting minutes and phone records that are typically scattered across a variety of EDMS, laptops, collaboration spaces and shared drives.

As explored in this paper, the tools typically used for the archiving and retrieval of these items simply cannot meet today’s business requirements. For example, you need the ability to quickly respond to agency queries, which requires immediate access to relevant, up- to-date information. In addition, regulatory compliance dictates that records are protected and access controlled—functionality not normally available with methods such as fileshares.

There has to be a better way. For example, what if all of your regulatory submissions for medicinal products were centralized and easily searchable, allowing you to view all regulatory documentation and activity—including sequences, queries, telephone calls, meetings and email exchanges—along a single timeline?