Part 11 Compliance for Computerised Systems
What you’ll learn
Students will learn about how to ensure the computerised system is part 11 compliant. They will not just depend on certificate issued by the computerised system
This course includes:
Yes. While going through this course, you should be focussed for learning and understand in detail. you can take the notes as well. Furthermore, if you have any questions, please raise your questions in comment section. I will revert you.
Now a days, many pharmaceutical companies are looking for the part 11 compliant computerised systems. To ensure part 11 compliant, they just focus on validation of computerised system. I want to inform you all that, only validation activity can not ensure your computerised system as part 11 compliant. So, then the next question comes in to mind is, what to do? For answering this only, I have created this learning course. Here, you will learn exact requirements of USFDA as per 21 CFR part 11, EUGMP annex 11 and also some key aspects of data integrity. During this through discussion, we will discuss, 21 CFR Part 11 Broad Understanding, Application of guide, Overall approach to part 11 requirement, Clarity provided by FDA on guidance, Documents identified for compliance, Approach specific to Part 11 requirements, Key differences between EUGMP annex 11 & 21 CFR/eCFR part 11. Additionally as we will explain that, not only these guides to be followed. But also need to understand the data integrity requirements. We will discuss some FDA citations on Data Integrity, Introduction to Data Integrity, How to design system and Processes to assure integrity of Data, Role of Blank formats in controlling Data Integrity, Controlling master templates, Practical implementation – GAP analysis strategy, DI Training, Presenting DI status, QA role/oversight, Points triggering the thought process etc.
Furthermore, this discussion videos will take to understand the guideline expectations and practical approach. Additionally, I have made some learning videos for how to be ensure audit preparedness for compurterised systems and what are the common errors companies are making while ensuring part 11 compliance. Overall this complete learning course will guide you for claiming your computerised system as part 11 compliant. Remember, just by providing one certificate or getting one certificate from computerised system supplier can not ensure your system is part 11 compliant.
Who this course is for:
- • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Project Managers • Software vendors and suppliers