Companies operating in the life science industry need market authorization in order to establish and maintain the basis of activity. The regulatory affairs departments take care of these matters. Dependent on a corporation´s size and operating model, information generated and disseminated internally or externally must be managed. Even more importantly, coordination and combination of all relevant information pieces shall lead to an elevated state, where data can be used to drive data. Definition of understanding and scope what shall be considered regulatory information and what shall be managed how is a pre-requisite for success.

Successful implementation of slick and efficient business processes employing computerized support requires a clear understanding of scope, needs, interfaces and value adding automation potential provided by information technology. Based on a holistic picture, the right decisions can be made on what vendor to select providing a system platform that allows for a flexible yet fit-for purpose foundations to sharpen the transformation. Also, it is a decisive factor how requirements are documented as a communication and expectation management vehicle - and eventually in a format that can easily be translated and carried through the various validation and testing sequences without friction.

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