Computerized systems validation. Maintenance of their validated status

Within the joint program of promoting implementation of the best practices in the Russian pharmaceutical industry, Federal State-funded Institution «State Institute of Drugs and Good Practices» and Pharmstrategy, Ltd. will hold an open expert-advisory workshop within the cycle «Computerized systems validation. Challenges and solutions» on the topic «Computerized systems validation. Maintenance of their validated status».

Computerized systems validation is the area where properly organized collaboration of experts from different subdivisions is of prime importance to achieve the best results. The program of the workshop is structured so that to secure careful consideration of all the key aspects of such collaboration.

The goal of the workshop is to strengthen the competencies of experts from pharmaceutical companies in the following areas:

• fulfillment of the requirements for data integrity (Annex 11 of the Order No. 916 of the Russian Ministry of Industry and Trade);
• knowing the structure of validation activities and computerized systems testing methods (presented in detail in GAMP 5);
• organizational approaches to execution of validation activities and maintenance of CS validated status (procurement, relations with suppliers, activities by the CS validation unit and the validation team, etc.).

This is the third workshop from the cycle dedicated to the steps of computerized systems validation described in GAMP 5. During the workshop, practical aspects of high-level testing will be investigated, and the issues of effective organization of validation activities will be discussed. All participants will get an access to the materials of previous workshops. The information covered during the workshop will be of use for both QA and IT experts from pharmaceutical companies.

Apart from lectures, the program of the workshop will include case studies. To the finalize the workshop, it will be suggested to study a specific case in regard to validation aspects of the labeling experiment executed according to the RF Government Decree No. 62 dd 24 January, 2017 together with experts and specialists from FSI «SID & GP».

The workshop will be held on 15-16 November, 2018.