Auditing Computer Systems for FDA and International Compliance

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. This seminar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation.

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

• 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.
• Assigning responsibilities
• 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
• Documenting detailed audit findings
• The audit summary report
• Effective follow up
• Presenting evidence of the audit to the FDA
• Case study: going through a life audit

• QA managers and personnel
• QC and Lab managers
• IT managers and system administrators
• Validation specialists
• Regulatory affairs
• Training departments
• Documentation department
• Consultants