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21 CFR Part 11


What is FDA Code of Federal Regulations 21 CFR Part 11?

21 CFR Part 11 means that companies are able to streamline their compliance with a number of FDA regulations by submitting the required documnetation in an electronic format.

Of particular note is that it calls for the documentation of electronic signatures throughout a workflow which are seen as equivalent to handwritten signatures on paper-based records. It is of specific importance within the Life Sciences industry.

With Sword Achiever you have a single solution which is ease to use and flexible enough to meet any need supporting audit trails and digital signatures. Contact us to find out more.

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