CSV & Testing Services

“Our collaboration with wega Informatik enabled us to convert early stage academic documentation into a comprehensive, MDR compliant technical dossier. Their structured V&V plan and thorough testing supplied the Notified Body with the requisite evidence, facilitating CE marking for both PC and VR implementations. The team's expertise in ISO, IEC and ISTQB standards supported our regulatory approvals. wega also delivered a comprehensive workshop on complex regulatory requirements for AI enabled medical devices. Their practical guidance on standards, risk management, and FDA aligned validation accelerated our internal readiness and informed our strategic decisions.”

Charly Leprince, QARA Manager SaMD at Specto Medical AG

"Our workshop with the wega team provided a structured and very clear insight into standards, legal frameworks, and validation processes. The clear message that validation should always be based on process relevance and risk rather than a scattergun approach was particularly valuable. This practical approach strengthens biobanks' understanding of quality and compliance."

Dr. Alexandra Stege, Leitung der Zentralen Biobank Charité, 2025

"wega has been a trusted partner in both the implementation and ongoing support of our PK/PD database solution for over five years. Their approach has consistently demonstrated efficiency, pro-activity, and adaptability to our evolving needs. Notably, wega also led the successful validation of the system in alignment with GxP compliance requirements. We sincerely appreciate their professionalism, technical expertise, and the highly effective collaboration throughout our partnership."

N. Martinier, Clinical Data Manager, Product Development Team, MMV, 2025

"We worked with wega to implement and customize our ticketing system. They delivered a solution that perfectly met our needs. Their comprehensive training empowered our team to manage the system independently going forward. We look forward to continuing this partnership on future projects as our business grows. "

K. Müsch, QARA, 2025

"Thanks to wega's support in implementing the new archiving of our chromatography data in Chromeleon, our processes have become leaner, data access more efficient and the paper archive redundant. A real improvement in our daily work!"

Ilaria Isella, Pharmaceutical Development Laboratory Project Manager, Sintetica S.A, 2025

"The collaboration with wega Informatik was crucial for the successful implementation of our S/4HANA solution. Their in-depth expertise in the field of CSV (Computer System Validation) and their practice-oriented approach ensured that the necessary regulatory requirements in medical technology were met. wega Informatik demonstrated great skill in working across departments and delivered well thought-out solutions in a short space of time."

Thomas Hanselmann, Head IT Applications & Marius Heizmann,Group Manager Design Quality Engineering, Medartis, 2024

"wega IT provided us with excellent support during the validation of our merchandise management system. The team worked extremely professionally, reliably and flexibly and was particularly impressive thanks to its extensive experience. We would like to thank them for their competent and successful cooperation."

Rob Lotthrincx, Managing Director, ABF Pharmaceutical Services GmbH, 2024

"wega has successfully helped us evaluate our data infrastructure and needs and validate our systems against the ISO requirements that we implement in all of our studies. The company is also a reliable and knowledgeable partner in the area of clinical data. Their support in monitoring and reviewing data quality in a complex study has helped us to complete the activities required for an expedited regulatory review in a timely manner."

FIND

"We would like to thank wega for the very well-structured, organized and pleasant collaboration on our CSV. The result was very convincing."

Pascal Burri, Head of Diagnostics, Bencard AG

"wega provided us with significant support in the validation of a LIMS - from the training of employees and the creation of a validation plan through to operational support for the validation. Thanks to the high level of technical expertise and punctual delivery, we were able to meet the tight schedule."

PhytoLab GmbH & Co. KG