Use case presentation – ViMS at Kern Pharma

Presentation of the use of ViMS – Validation information Management System at Kern Pharma.

On May 22nd, Qualitate, in collaboration with Micro Focus and Kern Pharma, organized a breakfast session in Badalona attended by important pharmaceutical companies from the region.

We were glad to welcome representatives of important pharmaceutical companies such as o Ferrer, Grifols, Hipra, Kern Pharma, Menarini and Reig Jofre.

After introductions by Qualitate and Micro Focus, representatives of the Kern Pharma IT Validations department presented their experiences of using ViMS on a day-to-day basis, including a demonstration of how they manage the validation process with ViMS.

The presentation generated a lot of participation and a good debate about validation practices and how these can be managed with ViMS. Among the many benefits, those that generated most interaction and interest were the following:

• Ability to manage user requirements, design reviews, risks, tests protocols, executions and evidences, reports and defects registered in a single online system.
• Reduction in time and effort required for reviews and apporvals and the overall validation process.
• Fully paperless validation leveraging the electronic records and signatures in the system.
• Easy generation of standard and custom reports.
• Convenient online execution of protocols and capture of test evidence.
• Complete traceability and visibility of the content registered in the system and its audit trail to guarantee the integrity of the validation data and records.

The main conclusion of the session is that although organizational structures may vary, compliance and regulatory requirements are common to all, and for that reason ViMS is an excellent opportunity to work in a structured way, eliminating any paper and its filing for the validation of  computerized systems.

The average rating of  the event – 4.7 out of 5 –  reflected the interest and participation observed during the presentations.

We want to thank Kern Pharma for its magnificent presentation of ViMS, highly valued by the attendees, and all the attendees and speakers for their participation in a very interesting event.