The Data integrity is increasingly becoming the focus of the supervisory authorities in Europe. Whether it is GxP or 21 CFR Part 11, Annex 11, validation - on computerised systems and data governance within the framework of a pharmaceutical quality system high demands made. Lab data systems are becoming more complex and yet there are often too many manual activities which potential sources of error contain.
We know exactly what the data integrity requirements are and thus identify existing gaps in your current lab processes. Together with our experts from the Lab & Research IT division, we develop efficient and modern IT solutions - compliant and future-oriented. From audit trail review and segregation of duties to disaster recovery and change management, we support you in validating your IT systems with a focus on the next authority inspection.
We take over the following tasks for you:
- Validation of laboratory IT systems for quality control (QC), laboratory IT systems for development laboratories (GLP, GMP)
- Validation for systems such as Laboratory Information Management Systems (LIMS), Lab Execution Systems (LES), CDS, Titration System etc.