Computer System Validation
I'm looking for some help with starting a Computer System Validation SOP!!! I was scheduled for a class but it was cancelled (and not available again until June). Any help would be greatly appreciated- I don't even know where to start :dunno:
Computer System Validation SOP
Hi Jamie,
You need to put in more details of what you are looking for , is it software , hardware. Is this for a production audit or IT audit.
The SOP will differ for each topic. Also , the depth required will be different for each.
You say that you were scheduled for a course...Do you have outline/topics for the course? If yes, then share the topics and forum can help you better.
From a HSE risk analysis perspective for office environment , I did a risk analysis some years back. Attaching the same. Whether you need it or not , will depend on what you need SOP for.
Hope it helps.
Attached Files
I'm looking for assistance specifically with meeting the data integrity/computer system validation requirements under FSMA/FDA. The course discussion topics are:
- The regulatory expectations for computer validation
- Relevant FDA warning letters
- The tasks and deliverables expected for computer validation
- Why validation processes vary so much
- Strategies for practical, yet defensible computer validation
- Sops required for system operation and maintenance
- 21 CFR part 11 and it's implications for common regulations
- An active discussion of part 11 examples and audience questions
- The implications of GAMP 5 on computer validation and how to transition from GAMP 4
- Auditing GXP computer systems and suppliers