Data Integrity
The increasing number of data integrity violations is causing a paradigm shift in the GxP-regulated environment. In collaboration with our clients, we develop the optimal strategies for the prevention, detection and monitoring of data integrity violations.
Ensuring data integrity and compliance with US FDA 21 CFR Part 11 and EU-GMP Annex 11 requirements
Data is an essential part of our lives and many things cannot be expressed without it. Whereas data used to be bound primarily in fixed form on paper or other media, in the information age data can be evaluated and combined at will. Manipulations cannot always be detected early enough. The answer to the challenge of ensuring the evidential value of electronic data is data integrity.
Especially in the health care sector, however, correct and trustworthy data create the basis for the effective use of pharmaceuticals and medical devices for the benefit of patients and other affected persons. Quality and reliability are therefore of paramount importance.
If the validation creates confidence to the effect that processes and systems function as intended, the quality of products and their manufacture is verified with data of high integrity.
