Project management frameworks following a waterfall approach are not state-of-the-art anymore. Companies have to respond and adapt to the fast-changing environments and requirements within a business. This was the case for one of our customers, a global US pharmaceutical company, who came to Eraneos for help in establishing a CSV agile framework. It was hoped this would allow the organization to work agile while, at the same time, fulfilling the compliance requirements from regulatory authorities.
However, the challenge with this particular company was fitting its validation activities, which were based on the classic V-model, to an agile development approach while also taking into consideration all the tools already in use, for example, DMS, Solution Manager, HP, and ALM Proton.
We reviewed the company’s policies for CSV alongside its project management frameworks and the tools and processes used to support CSV activities. Together with the company, we identified potential gaps and challenges and after implementing several tool enhancements for traceability, we drafted the agile CSV framework and got it endorsed by QA/e-Compliance.
A global pharmaceutical company with a focus on the treatment of eye diseases. Currently known as the largest eye care device company in the world that operates in the ophthalmic surgical and vision care markets.
Based on the new agile CSV framework, the pharmaceutical company’s projects can now be executed with more flexibility. At the same time, CSV requirements have been fulfilled to ensure the system changes are maintained in their validated state.