[Feature] Examples for 21 CFR Part 11
Nobody has claimed this yet.
- Dominant language
- Python
- Stars
- 8
- Forks
- 1
- Avg merge
- 18h 23m
- Merged PRs (30d)
- 63
Description
Affected area
Cross-product tests
What problem are you trying to solve?
Customers who want to use VIP for 21 CFR Part 11 (https://www.rzsoftware.com/blog/21-fscr-part-11) may want to just use VIP as-is and then feed this information into other systems they have. Another potential solution here is to do more of what's needed for 21 CFR Part 11 in VIP, including adding better traceability for this. We have examples in VIP to allow people to build more themselves and this would be a new one.
Proposed solution
This has been started already started in a very draft form at:
https://github.com/posit-dev/vip/blob/feat/part11-traceability/examples/21CFR_part11_validation/README.md
And more details at https://posit-dev.github.io/vip/pr-preview-site/pr-627/getting-started/#compliance-traceability
Alternatives considered
No response
Contributor guide
No contributing guide indexed for this repository
First steps
- Read the whole issue, then the project's contributing guide.
- Comment on the issue to say you are picking it up — it saves two people doing the same work.
- Fork the repository and make your change on a branch.
- Open a pull request that references the issue number.
Research direction
Start with examples/21CFR_part11_validation/README.md and compare the draft with the compliance-traceability section in the linked VIP documentation preview. Review the existing cross-product examples to understand the expected structure and scope. Done means a complete 21 CFR Part 11 example that demonstrates the proposed traceability workflow for feeding information into other systems.
Written by the indexing model from the issue text.
Assessment
- Tech stack
- python
- Domain
- documentation, testing-qa
- Issue type
- Feature
- Difficulty
- 4/5
- Estimated time
- 3-5 days
- Activity status
- Active
- Clarity
- Mostly clear
- Newbie friendliness
- 55/100