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Results from the 3rd Data Integrity Roundtable (7th Dec 2018)

28 data integrity experts from 13 different pharma companies, 1 logistics company, 1 software provider and 1 consultancy business met up in Basel to work on burning questions and their solutions.

It was an exciting day full of discussions, learning and contributing, and – most importantly – best-practice sharing with peers!

Top Results:

Data Integrity in QC Labs

The case study of a big pharma company showed that IT-landscape gaps behind data integrity findings.

The reasons: Great part of the lab equipment is still running on Windows XP, data are locally stored, administration of users and privileges are managed locally,… just to mention a few. There are no updates available from the vendors’ side.

The solution: The implementation of a globally harmonized environment. This way all Lab QC systems were integrated in an enterprise-wide system enabling a clearly managed landscape which allows for better user access management, automated back-ups etc.

 The result: The system closed the majority of data integrity gaps related to IT.

The importance of Data Records Management

Another case study highlighted the importance of Data Records Management. Data from old systems are stored on separate servers because very often it is impossible to transfer them to the new systems. Obviously, there are few to no solutions from the software providers for an automated data migration.

This observation was shared by many other Roundtable participants.

Data Integrity and the Cloud

Also concerning cloud solutions, the providers seem to be not flexible enough. Oftentimes, companies have to adapt their processes to the cloud solution, because the cloud solution features don’t fully suit the requirements of the pharma industry.

A lively discussion arose, at the end of which stood a constructive proposal: The pharmaceutical manufacturers should join forces and develop standard requirements that fit their needs. These can then be submitted to the software providers to help them adapt their offerings for the pharmaceutical industry.

These are only 3 examples for the constructive work of the Data Integrity Roundtable. Many more cases were discussed, and best practices shared. Also future-oriented topics like block chain and artificial intelligence were touched.

At the end of the busy day, everybody agreed that this event should be continued.

Many thanks to chairman and co-moderator Stefan Wurzer, Global Data Integrity Project Lead, from Hoffmann-La Roche, for leading us smoothly through the day.

We are looking forward to organize the 4th Data Integrity Roundtable in summer 2019.

Data Integrity

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