We care

Within a pharmaceutical company the QMS processes and related documentation for R&D was dispersed across multiple IT systems and Excel tools. Moving towards a largely standard cloud solution was planned to foster collaboration, transparency and standardization and thus lead to significant quality improvements and efficiency gains, while observing and supporting good practices (GxP) prescribed by regulators and legislators.

The project was planned to deliver following an agile approach with multiple business work streams and a unified team of application consultants from the system supplier.

We act

As the IT project lead we were responsible for the integrated project plan, budget and resourcing. We managed the timely delivery of the key project milestones within budget and quality. Contributing to the project success was the tight collaboration with business and supplier resources and interpreting between the spheres. Actively supporting the accompanying change management initiative helped continual improvement during the agile implementation and finally fast system adoption by users.

We deliver

The project delivered a key digitalization goal, reaching a new maturity level of their R&D quality management system. The project acted as a pilot for taking central, regulated systems into the cloud thus leveraging cross-industry standards and reducing maintenance cost.