21 CFR Part 11 (fondly called "part 11") is the US Government's law about electronic signatures for medical devices. What is in the regulation and what do you need to know when implementing a system that will replace traditional signatures with electronic ones? You can read the FDA guidance - or first take a quick browse through the summary below.
1. Part 11 Defined
Part 11 is the FDAs requirement for digital signatures. As a rule of thumb, think of a part 11 signature as having all of the same attributes of a pen-to-paper signature: (a) it is not replicable by others, (b) it stays with the person regardless of their affiliation, and (c) it doesn't go away unless the document itself goes away.
2. Guidance Documents to be aware of
Here is a list of the various FDA documents that apply to part 11.
- Electronic Records; Electronic Signatures, Validation
- Electronic Records; Electronic Signatures, Glossary of Terms
- Electronic Records; Electronic Signatures, Time Stamps
- Electronic Records; Electronic Signatures, Maintenance of Electronic Records
- Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records
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3. Reason #3 why everyone should be writing list-based posts
You can use bulleted lists, numbered list, or multiple headings. Include as many steps, numbers, or bullets that will allow you to discuss your topic thoroughly.Here are some pointers to make the best possible body of your blog:
- Include visuals
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CONCLUSION:
Now it’s time to say goodbye and wrap up your post. Remind your readers of your key takeaway, reiterate what your readers need to do to get the desired result, and ask a question about how they see the topic to encourage comments and conversation. Don't forget to include a Call-to-Action!
Congratulations! What a lovely list post you've created!