Revised Guidelines on Data Integrity and Validation of Computerised Systems

The guidelines were elaborated by the experts of the FSI “State Institute of Drugs and Good Practices”, Russian Ministry of Industry and Trade, with the support of the PQE company (Italy) and submitted to the EEC working group by the ISPE Eurasian Economic Union Affiliate. After certain technical procedures are completed, the EEC administration will adopt the guidelines as EEC Recommendations.

Following the results of the first reading, during the public discussion, the Association of Clinical Trials Organisations and expert community offered a number of suggestions related mainly to the application of the Guidelines beyond the spheres regulated by the GMP rules. After revision by the authoring team, the EEC working group approved a version of the Guidelines that can be voluntarily used in other areas of good practices (GxP): GDP, GCP, GLP, and GVP, as well as other related areas, such as drug quality control laboratories.

The unanimous adoption of the Guidelines by the EEC Working Group in an unprecedentedly short time with a minimal number of revisions and comments indicates both the high level of preparation of the document and the high level of interest of the industry.

The final English version will be available after the adoption of the EEC Recommendation.