The European Medicines Agency (EMA) publishes “Reflection Papers” to provide expectations for industry.
This guidance, Reflection Paper for Laboratories that Perform the Analysis or Evaluation of Clinical Trial Samples, was adopted by the Good Clinical Practices (GSP) Inspectors Working group on February 28, 2012.
See the following sections of the reflection paper for computer system topics:
- 5.0 – Definitions of Computerised System and Validation of a Computerised System
- 6.16 - Expectations for computer validation, documentation, interfaces, upgrades, patches, risk assessment, re-validation, location, administration, access rights, and disaster recovery
- 6.17 - Expectations for audits of computer validation documentation
- 6.19 - Expectations for SOPs on computer system installation, validation, and maintenance