The most scientifically sound regulations for digital records are made from Pharma authorities. However, they also are the most expensive and inflexible ones.

Recent papers suggest that science has problems with reproducibility maybe caused by pressure for publications. The pressure, for instance, may lead to selected results, supporting a certain hypothesis. Records get lost and investigation is difficult. In 2020 it even hit a noble price winner, who had to recall a paper.

Selective results in Pharma regulations are called “testing into compliance”. If revealed, it will have drastic financial and reputation consequences for a pharma company.

Rules for digitalization do not have to be reinvented for science, but should leave some more flexibility, e.g. when it comes to validation documents.

Facilitation of digitalization is in the focus of instrument suppliers through technical controls that enforce compliance and enable reinvestigation of “sensational results” to confirm they were not accidental.

The downside of digitalization is the integration cost and effort. Missing standards is only one aspect of this. Our solution is commercially available platform software, maintained by the supplier. It connects a multitude of instruments and different applications in a single effort.