21 CFR Part 11 provides the basic framework for computer systems used to generate records and data used for analysis and presentation. Validated computerized systems are integral for producing accurate, reliable and consistent data. For many small to mid-sized organizations, proper documentation is a daunting task. In this seminar, we will simplify the validation process and provide practical tips in creating validation documents and procedures that will have you ready for your next audit. We will also provide you with helpful tips when validating commercial off-the-shelf (COTS) software.
This seminar will discuss the basics of computerized systems validation and the procedural controls to maintain compliance. Validation is on-going effort from development all the way to eventual retirement. You will hear about validation plans, user requirements, test plans, test reports, change controls, standard operating procedures, data backup and business continuity. Case studies will be used to highlight common issues and potential solutions.
Areas to be Covered:
Validation Plans, Requirements, Specifications, and Test Reports
Data backup and business continuity
Tips when validating COTS software
Common audit findings and tips for a successful audit
Who will Benefit:
This webinar is a must attend for:
Everyone involved in computer system validation
Anyone selecting computer systems intended for FDA regulated environments
Information technology professionals responsible for files or network locations
Quality professionals who organize, document and verify system compliance
Executives evaluating requirements Part 11 compliant systems