From validation to audit success: How Pharmore GmbH works

As a pharmaceutical wholesaler and pharmaceutical company, Pharmore GmbH, part of the BA.Unternehmensgruppe, supplies pharmacies and hospitals with medicines. The focus is on worldwide procurement of medicines not approved in Germany as well as the distribution of its own products. As a pharmaceutical specialist, the company operates under typical regulatory conditions such as GDP, EU GMP Annex 11, and GAMP 5. The requirements for system validation, documentation, and traceability? Correspondingly high.

Until now, Pharmore had been working with Microsoft Dynamics NAV. With the desire to switch to Microsoft Business Central, it was clear from the outset: only a well thought-out and smooth validation approach would reliably stand up to quality audits. But it was not just a matter of formally meeting the requirements. The person responsible for validation at Pharmore recalls:

For computer system validation, the Pharmore project team turned to the Yaveon Compliance Kit:

“The lists with User Requirements Specification, Functional Specification and Business Process Master List were initially very extensive. But they immediately gave us a very good overview of which standard processes exist at Yaveon and Microsoft at all. We were able to build on that optimally.”

It was precisely this overview that was crucial in making an informed decision: What can be mapped in the standard, and where are adjustments necessary? The necessary flexibility was retained. Pharmore was able to adapt all documents to the project-specific requirements without losing the structure.

In addition to the content for the validation, collaboration also played an important role in the project. After all, short coordination channels are absolutely crucial, especially during the validation phase. “We always had a contact person at Yaveon. Especially toward the end of the validation, when the decisive tests were running, we always got appointments very quickly whenever we had questions. That was a great relief.”

What makes the difference in the ERP project becomes clear in retrospect above all in the structure of the validation: from the initial process understanding to the final test report, everything follows a clear logic - a key point: “I really liked the structure of how validation with Yaveon documents is done. It runs through all documents, from the BPML via URS and FS all the way to the test plans and test reports. This keeps the relationships understandable at all times.”

But the real practical test for any validation is the audit. Since the introduction of the ERP system, Pharmore has already undergone several customer audits. The result is convincing: “We had no findings in the audits with regard to the validation.”

There is also a positive effect in day-to-day work internally: the clear structure reduces dependence on individual experts. “The team is now familiar with it, because even when changes are made, the validation logic remains very comparable. You don’t always have to train yourself or new colleagues on how the validation works. That saves a great deal of time.”

Introducing the ERP system brought Pharmore both security and relief in one project: what was previously seen as necessary effort is now a stable part of the way of working. Pharmore’s verdict is clear: “The validation with Yaveon went very smoothly. There was absolutely nothing to complain about.”