Description
The data integrity is increasingly becoming a focus for regulatory authorities in Europe. Whether GxP, 21 CFR Part 11, Annex 11, or validation—in computer-based systems and data governance within the framework of a pharmaceutical quality system high demands . Lab data systems are becoming more complex, yet there are often too many manual tasks that potential sources of error .
We have a thorough understandingof data integrity requirements, which allows us to identify gaps in your current laboratory processes. Together with our experts inLab & Research IT,we develop efficient and modern IT solutions—compliant and future-oriented.From audit trail reviews and segregation of duties to disaster recovery and change management, we support you in validating your IT systems witha focus on the next regulatory inspection.
We handle the following tasks for you:
- Validation of laboratory IT systems for quality control (QC) and laboratory IT systems for development laboratories (GLP, GMP)
- Validation for systems such as Laboratory Information Management Systems (LIMS), Lab Execution Systems (LES), CDS, titration systems, etc.
