Centralized System Approach For Part 11 Compliancy

AstraZeneca Corporate Electronic Record / Electronic Signatures, ER/ES, project was initialized at the same time for all AstraZeneca sites worldwide and an ER/ES Corporate Certification Letter was delivered to FDA in July 1999.

Ambassadors for local sites started with information spreading and training with material for education, and the compilation and development with policies, guiding principles, and templates started up.

During the first period of time a lot of parallel activities started on each site, a lot of efforts were spent on inventory and summary of the actual status of the systems, both technically, procedurally and for substantiation, also on preliminary assessment of scoop of work so following issues were addressed:

• System and infrastructure inventory
• Gap analysis and results
• Implementation/Action plans
• Cost Estimation and Risk Analysis
• Remedial action line items
• Computer validation and system documentation
• Company SOPs and policies
• Technology solutions