Most biotech and pharmaceutical professionals know that computer systems need to be validated and Part 11 compliant, but for many, the subject can be disorienting. Your expertise is in clinical research, not in the technology you use. Maybe your organization has recently received audit findings from prospective or current clients and you’re not sure how to respond. Maybe you knowwhat needs to be done, but the list of compliance activities and documentation required is overwhelming. Where do you start? How do you prioritize?
You are not alone! The increased number of types and scope of systems used in clinical research and the increased focus on data and record integrity by global regulatory agencies highlight the need to separate myths from reality and develop an actionable plan for addressing risk areas in a prioritized manner. This course will provide tips on developing an action plan for Part 11 compliance that’s appropriately sized for your organization and prioritizing activities based on the risk they represent to you. Implementing such a plan will allow you to demonstrate to regulators that your systems are under control, your computing environment is stable, and your data are reliable.
At the completion of this session, you will be able to:
- Recognize some of the misinformation circulating about Part 11
- Identify the types of systems and vendors/service providers that are subject to Part 11 requirements (not all of them are!) and separate your responsibilities from your vendor’s
- Identify basic validation documentation requirements for computer systems
- Determine SOP starting points
- Determine how risk assessments can be used for your current systems and vendors
- Interpret some common audit findings to better formulate your response
- Define an actionable plan for Part 11 compliance