These regulations stipulate in detail how documents are to be dealt with and—as in the case of the Corrective And Preventive Action (CAPA) regulation—how deviations from standards, customer complaints, or audit findings and the resulting corrective and preventative measures have to be recorded, evaluated, documented, and much more. In the case of cooperation across multiple locations and parts of a company in particular, the level of complexity quickly rises. For example, a large number of documents need to be accessible across locations at the same time in order to be available for any ad hoc audits.
Getting compliance costs under control
As the Head of Quality Management at Vifor Pharma, Dr. Thomas Kaspar is the highest authority in matters of quality management, and also has shared responsibility for compliance. He joined the company in 2000 and has seen first-hand how quickly Vifor Pharma has grown organically and internationally. “We needed to harmonise a system and process environment that was becoming increasingly complex. And we had to do this in our local specialist departments but also across all the different organisations in Switzerland, Canada, the USA, UK, and France. Once we reached a certain point, our growth and the multitude of individual systems made it impossible to guarantee compliance at a reasonable cost using manual methods. The provision of audit-relevant documents alone became noticeably harder; we would have had to employ an army of staff to be completely compliant. The audit authorities also criticized the lack of interaction between our individual systems and the absence of any overall perspective,” Dr. Kaspar says of the situation at the beginning of 2010.
OpenText offers a comprehensive solution and budget security
The introduction of the ECM system kicked off in 2010. “Unlike the major players in our sector, we only have limited resources and funds available for IT projects. We evaluated ECM providers that were of a similar size to us and a number of specialised systems, including in terms of costs. We chose OpenText and Deloitte for a number of reasons; the OpenText solutions have proven their worth many times over in practical applications in our sector and they also meet our company-specific requirements,” explains Dr. Kaspar. “Deloitte impressed us with its experience of complex OpenText projects, its outstanding knowledge of the sector, and its structured approach. Both parties also guaranteed us budget security. We could, therefore, be certain that the project costs would not get out of hand,” concludes Dr. Kaspar.
Prototype stage reached in just a few months
The objective was firmed up after the initial workshops. By summer 2010, Deloitte had developed an individual basic package for the departments of Quality Management, Regulatory Affairs, and Research and Development. For the R&D department, a central repository was a major priority in order to be able to efficiently handle and manage the enormous data volume that accumulates over many years from the research of a drug to its market launch in a legally compliant manner. The prototype was delivered on the basis of the OpenText Quality Management and OpenText Regulated Documents in November 2010, and was subsequently tested and optimised.