Preparing for a Software Quality Audit
The prospect of a software quality audit can be intimidating and the work to prepare can seem daunting. However, audits are not generally conducted according to random processes, nor do auditors ask random questions. By learning what to expect, you can be prepared!
In this free webinar, you will receive an overview of standard audit terminology, roles and processes. Then you will learn how to prepare your validation documentation, standard operating procedures, facilities, and personnel for the software quality audit.
We'll review frequently asked questions and checklists from international regulatory guidance. The session will also address approaches to handling problem topics. Then you will learn best practice tactics for use during the audit.
And finally, to help you determine where to focus your preparation efforts, this session will provide statistics from FDA inspections on the most prevalent software quality topics and the most cited typed of computer systems.
Computer Audit Webinar Topics:
- Fundamental audit terminology, roles and practices
- Key US and international regulatory guidelines regarding software quality audits
- Audit preparation for staff, facilities, and documentation
- Common software quality audit questions
- Best practices during an audit
- Accommodating requests for access to computer systems and data
- Most frequently inspected systems and software quality topics