Overview: This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation.
Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right, audits can help to improve quality of computer system operation and uptime. In addition audits are also an excellent tool to prepare your organization and staff for external audits, e.g., FDA inspection. However, without a clear strategy audits can become quite complex and ineffective.
Reference material for easy implementation:
SOPs: Validation of Commercial Off-the-Shelf Computer Systems
Checklist: Using computers in FDA regulated environments
Validation templates and examples
Areas Covered in the Session:
Regulatory requirements: FDA, EU, PIC/S
Audit recommendations from the FDA Quality System guidance for cGMPs
Effective development and use of audit checklists
Developing an SOP for audits of computer systems.
Conducting the audit: review procedures, walk through the computer system area
Most critical questions to ask
Auditing for data integrity
Auditing in preparation for FDA's ongoing Part 11 initiative