Did you know that 79% of the FDA’s warning letters in recent years cited data integrity concerns? And the trend has been worsening in recent years!
Warning letters commonly cite ineffective access controls, improper back-up of data, deleting and editing of data, disabled audit-trails, discrepancies between audit trail data and printed documents, etc.
An area with a significant risk for data integrity is the recipe management process.
It consists of a complex workflow covering steps from creating a recipe to the effective start of manufacturing. These steps include sharing documents between stakeholders, approvals, status management, download, and recipe data storage. Surprisingly, more than half of life science manufacturers perform these process steps (at least in part) manually, often relying on paper-based documents and physical signoffs, exposing the whole process inevitably to data integrity risks.
The most effective way to bridge this gap is to digitalize the whole process. MePIS RM, the recipe management software provided by Metronik, digitalizes all steps in the recipe management workflow, from creating a recipe to storing recipe data, ensuring rock-solid data integrity (and keeping away potential warning letters from the FDA).
For more information, please contact dejan.bozic@metronik.si.
