Description
The data integrity is increasingly becoming the focus of supervisory authorities in Europe. Whether GxP or 21 CFR Part 11, Annex 11, validation - computerized systems computerized systems and data governance within the framework of a pharmaceutical quality system high requirements placed on them. Lab data systems are becoming more complex and yet there are often too many manual activities that potential sources of error sources of error.
We know the requirements for data integrity inside out and identify existing gaps in your current laboratory processes. Together with our specialists from the Lab & Research IT department, 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 government inspection.
We take on the following tasks for you:
- Validation of laboratory IT systems for quality control (QC), laboratory IT systems for development laboratories (GLP, GMP)
- Validierung für Systeme wie Labor-Informations-Management-Systeme (LIMS), Lab Execution Systeme (LES), CDS, Titration System usw.
