Organizational Setup to Integrate Data Management, Software Development, and User Convenience from Research to GMP Production in Pharma Biotech

Setup for an effective, agile, and lean organization

Modern biotech production requires flexible and fast transfers from research & development to manufacturing.

Not only within one site, but also to other R&D facilities and manufacturing sites around the globe to ensure a continuous supply to the pipelines, for the patients.

Therefore, transfers are accelarated if the same analytical devices, reagents, and methods are used. Results and analysis can then be directly compared without corrective factors and fed into a global cloud data collection to which all sites have access, the success of a global data collection relies on the coordinated operation of the analytical devices and an IT middleware to collect, transfer, and store the data. 

Data integrity and good manufacturing practice (GMP) requirements must be fulfilled, master files and raw meta data defined, bug fixes and software development synchronized.

Tim Noetzel

Manager Lab Data Solutions
Roche Pharmaceuticals

How does Roche Pharma meet these challenges?

Read about the vision of a setup for an effective, agile, and lean organization to coordinate needs from users and IT developers.

Interested in more details? Download the biopharm booklet and access the full article on p. 37.



This new way of working is more cost effective, more flexible towards the voice of the users, and enables faster decision making.


Tim Noetzel, Manager Lab Data Solutions, Roche Pharmaceuticals

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