Company: Epista Life Science, 70+ employees
Industries: Consultants for Pharma, Medical Device, Biotech
Geography: Headquarter in Copenhagen, Denmark; Offices in Villingen, Germany, Lund & Stockholm, Sweden
Solution: Veeva QualityOne
Epista Life Science is a consultancy dedicated to continuously improving regulatory compliance. They turn compliance obstacles into business opportunities for their clients and the life science industry as a whole. They achieve their ambitious mission using a three-part strategy: First, they pioneer new methodologies to help the life science industry stay in control when moving to new technology and business paradigms. Second, they bridge the gap between IT, quality and line-ofbusiness areas so quality is aligned efficiently across the entire organization. And third, they benchmark regulatory compliance maturity across the life science industry.
Historically, Epista Life Science used a paper based quality management system (QMS). As the company grew, this became an increasing challenge. For example, they struggled to ensure that training was up-to-date. During an internal audit, Epista found that some of the project participants had several gaps in their training. This demonstrated that tracking and follow-up activities in the paper-based system were not sufficient, and it was too easy for the missing training to fall between the cracks.
GDPR compliance recently became apparent as another related process and document management challenge. It was too much work to be compliant with mountains of paper. Moving to an electronic system would make GDPR compliance more streamlined as all data is in one place.
To address both of these challenges, as well as overall compliance and process efficiency, they began looking for a modern QMS.
Epista selected Veeva QualityOne for multiple reasons. Malene Mayntzhusen Christiansen, QA Manager and Principal Consultant at Epista, explains: “We had several clients who were satisfied with their Veeva Vaults, so that was the first step. Then, Veeva offered a solution that fit our company as a consultancy very well. The solution doesn’t overwhelm us with a lot of processes we don’t need. It really fits our needs.”
Epista Life Science uses Veeva QualityOne to manage Standard Operating Procedures (SOP), handle internal and external audits, and track SOP training. QualityOne brings clear benefits for Epista, especially for their QA manager Malene Mayntzhusen Christiansen: “It’s an easy system to implement and use. As well as being QA Manager, I’m also the system owner for our Veeva solution. I’ve found that it is easy to set up to fit our business needs, and it’s easy to administrate afterwards. Also, the end users have had very few questions about how to use the system. No extensive system training was needed. It’s been very intuitive.”
Mayntzhusen Christiansen no longer has to focus on time-consuming tasks like chasing down training records, or ensuring documents are reviewed and approved. Veeva QualityOne has made maintaining compliance easy.