Assessment and Remediation of the Company IT System based on AS400

Operating in a sector that is particularly attentive to the relevant regulations, the client company needed to carry out a complete diagnosis of the company’s IT system to make it even more compliant with the GAMP guidelines and Annex 11 regulations.

The client turned to the specific technical expertise of the S4BT CSV – Computer System Validation – team.

The project team structured the work in two macro-phases:

1. Assessment:

analysis of the management system used by the client company (based on AS400) to make it more robust in implementing the regulations.

The work team therefore:

• analysed the existing technical documentation (procedures, validation protocols, etc.).
• verified the use of the system in the field by the users (with particular attention to the functionalities in use and the data managed) by interviewing both the reference users for the company areas involved (Logistics, Production, Quality Control, Administration) and the resources dedicated to the management and administration of the system by drafting a final report containing a Risk analysis based on the GxP criticalities managed by the IT system and the actions to be taken.

2. Remediation: revalidation of the computer system used in the management of the client company’s most important departments:

• Logistics
• Laboratories
• Production laboratory
• Accounting
• Administration

The validation strategy implemented was conceived precisely to improve alignment with CFR 21 part 11 and Annex 11 regulations.

The CSV consultants then drafted and executed the following documents:

• User Requirements Specification: with the aim of defining the main user requirements
• Validation Master Plan: to define the strategy and activities needed to guarantee with
  documented evidence that the company ERP system used in the iMO plant attains and maintains validation status
• Installation Qualification (IQ) proving compliance of system installation with the supplier’s hardware and software specifications
• Operational Qualification (OQ) providing documentary evidence that the computer system in use in the facility is able to operate in accordance with the user’s needs for regulatory, administrative, technological, production, laboratory, and logistical purposes.
• Performance Qualification (PQ) providing documentary evidence that the AS/400 computer system can guarantee compliance in the production environment.

Finally, the work team prepared the final report.