Centralized System Approach For Part 11 Compliancy
The paper presents a case study on how the worlds largest pharmaceutical tablets manufacturing site achieved 21 CFR Part 11 compliancy on their manufacturing equipment by using a central information system. The paper shows the development of User Requirements Specification and Information System Design. It shows the Information Systems Implementation and how the project organized to be able to work with a large number of machines and against a tight time schedule. The technical solutions to fulfill the 21 CFR Part 11 requirements was the primary goal of the project but it also gives an added value to AstraZeneca since the system can and will be used for production optimizations and planning purpose.