When Validation of my SaaS Setup Calls – Practical Thoughts and Considerations before the Marriage (with my Provider)

Under today´s fierce market conditions, players are under constant pressure to optimize all activities of business operations to best channel scarce resources into the area of key competency. As a matter of fact, pharmaceutical companies are not only using information technology to gain an edge but even fully acquire complex computerized services from vendors. When supporting regulated areas of the value chain, things become tricky. The quintessence in setting up a successful partnership is proper planning and management of mutual expectations between provider and consumer - before the marriage and by using common sense.

This presentation is inspired by the 2015 Fall Cloud Symposium where the author presented on change management in a regulated setup. During preparation of the latter topic it became clear what dependencies are established and implications arise. The thought process was fostered by using a very practical change scenario, in which a potential flow of activities and "handshakes" was sketched out for both provider and consumer. In following this very basic pattern, needs, challenges, and mitigation means were identified on the way to create and maintain a validated computerized system.

This presentation intends to re-visit the content again not as a primary vehicle to demonstrate change management but to function as "a tool" in support of (1) communication processes between vendor and consumer (2) identification of potential risk areas (3) being an anchor point for needs to be addressed in contracts and SLAs (4) opening the eyes regarding the restriction of degrees of freedom one enters.

Additional Info

  • Date(s): 06–Apr–2016
  • Event/Context: SQA 32nd Annual Meeting and Quality College Co-presentation with Manu Reddy, Bayer
  • Location(s): Grapevine, TX, U.S.A.
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