Where computerised systems are used in pre/clinical studies (GLP, GCP), manufacturing (GMP) or distribution (GDP) of medicinal products, they must be validated. The task of an inspection is to check the reliability of a computer-aided system on the basis of the validation evidence. The inspection of computer-aided systems usually takes place within the framework of the GxP inspections, but can be set as a separate inspection focus of a specialist inspector. Existing guidelines for inspection or validation apply to all GxPs.

An inspection usually begins with the request of the following documents:

• Company policy for computer validation
• Validation masterplan
• Validation plans / validation reports
• SOPs for IT or computers
• Third party services for maintenance and support
• Inventory list of all computer-aided systems
• List of GxP relevant systems
• Details on data protection, change control, information security, configuration management
• Staff qualification and training
• Summary of significant changes since last inspection

The general inspection strategy is variable, but can be as follows:

• Assessment of the validation proofs of the GxP-critical systems.
• Assessment of the system for maintaining the validated state and interaction between different organisational units involved in the process (e.g. IT support and GMP process owners).
• Insight into printouts and archives.
• All points of EU GMP Guide Annex 11 are relevant.
• Evidence for change management, configuration management, accuracy or reliability (bug reports).
• System security, access control and data integrity are aspects that are relevant for many systems.
• Verification of the implementation of specifications.

• AMBO 2009
• EU GMP Guide Annex 11
• PIC/S GUIDANCE ON GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED "GXP" ENVIRONMENTS (PI 011);