Data governance is an integral part of a regulated company’s quality system. Having a chromatography data system that has been implemented appropriately and is managed correctly can simplify system administration and ensure regulatory compliance (including 21 CFR Part 11) and adherence to data integrity guidelines.
In this white paper we discuss:
- Impact of the latest data integrity compliance guidelines
- Key aspects of the guidelines applicable to CDS systems
- Controls Thermo Scientific Chromeleon CDS apply to these guidelines