THE ROLE OF RELEASE MANAGEMENT IN PHARMACEUTICAL INDUSTRY

Due to the increasingly tight controls around compliance, pharmaceutical firms continue to seek more efficient ways to track, document and report on code changes in regulated applications such as those developed for managing samples and inventory. Such applications and electronic signatures associated with application development and workflows are subject to stringent regulations such as Sarbanes-Oxley Act (SOX), in addition to related audits. The pharmaceutical industry is in a state of flux, and the increasing regulations are making their job even more challenging! One of the outcomes of the introduction of the Sarbanes-Oxley Act focused organizations toward compliance and controlling changes in their environment. This adherence to compliance helped to stabilize environments to some extent and organizations spent a lot of money and energy into becoming compliant and putting controls into place. Every change introduced to the system has the ability to “break” the system.  The amount of changes and the speed at which change is introduced is directly proportional to disruptions in service and downtime. As the pharmaceutical environment is so integrated that one can follow all of the compliance requirements and pass single objects (change requests) through all testing and pass, yet still have problems once they reach production. Hence, the need to package sets of changes, the need for Release Management. Release Management acts as a coordinator in driving the release train from planning to deployment ensuring high quality on-schedule releases meeting the pharmaceutical business demand. This paper explains in detail about the effectively setting up the enterprise release management function and its benefits for the pharmaceutical industry