There’s been a lack of clarity around what’s needed to comply with 21 CFR Part 11, the US Food and Drug Administration’s regulations for inspecting electronic training records held by organizations.
Implementing electronic signatures and being able to clearly audit their use has often been a considerable challenge for businesses in the life sciences and pharma sectors.
This is an essential requirement for companies in these sectors looking to comply with the FDA’S CFR regulations. In-depth and rigorous auditing is increasingly sought-after by organizations in other sectors too, such as healthcare.
How a more detailed level of reporting leads to 21 CFR Part 11 compliance
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