Computer System Validation in the area of GCP

In accordance with Article 29 of Commission Directive 2005/28/EC, in order to harmonise the conduct of Good Clinical Practice (GCP) inspections by the competent authorities of the Member States, guidance documents containing the common provisions on the conduct of those inspections shall be published by the Commission after consultation with the Member States.

In accordance with this procedure, on the basis of input from the GCP Inspectors Working Group and after consultation of the Member States, GCP guidance is now published in Chapter IV of the Eudralex Volume 10.

• EMEA / Chapter IV : Recommendation on GCP Inspections

• GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS - Computer Systems

  The EU GCP inspectors agreed to use as the reference for inspection of Computer Systems the published PIC/S Guidance on Good Practices for Computerised Systems in Regulated “GXP” Environments (PI 011-3). The hyperlink to the PIC/S site is here.