Posts Tagged ‘CSV & Testing’
Referenzen : Specto Medical AG
“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…
Read MoreReferenzen : Leitung der Zentralen Biobank Charité
“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,…
Read MoreThe IT Odyssey of a Lab Head
It all began with a seemingly straightforward request:
“We need to validate a new quality control analytical method for DNA analysis.”
Dr. D., the Lab Head, immediately thought of the DNA-Saur, an instrument stored in the basement since a previous proof-of-concept initiative. At that time, only high-level requirements had been defined, and initial steps were taken to explore the experimental setup.
Read MoreReferenzen : MMV
“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…
Read MoreReferenzen : QARA
“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
Read MoreReferenzen : Sintetica
“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
Read MoreFlaky UI Automated Tests
A flaky test is an automated test that generates inconsistent results, without any change being made to the automated test script.
Read MoreReferenzen : Medartis
“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…
Read MoreReferenzen : ABF Pharmaceutical Services GmbH, R. Lotthrincx
“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
Read MoreWhy CI / CD Significantly Improves Your SaMD / MDSW Development Process
When developing standalone medical device software or software that is part of a hardware medical device, it is essential to have control over your code.
Read MoreImportance of Data Archival in a GxP-Regulated Environment
In analytical and industrial scientific research laboratories generation of comprehensive analytical data is a main purpose to serve scientific goals.
Read MoreWhy You Should Prefer Modern Tools to Traditional Methods for Creating CSV Documents
This article looks at the benefits and challenges of introducing modern documentation tools for CSV and highlights their role in simplifying processes, reducing errors and improving traceability…
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wega Breakfast – Navigating CSV in a S/4HANA Brownfield Transition
05 Dec 2024
This presentation examines the approach Medartis AG adopted for Computer System Validation (CSV) during its SAP S/4HANA brownfield transition.