21 CFR 11 - Require paper and hand signatures not electronic

Sue789

Involved In Discussions
I am generating a QMS for a start-up medical device company to ISO 13485 and 21 CFR 820. We are intending that all records will be electronic

My question is: In your experiences are there times in the business that will require paper and hand signatures not electronic.

I am trying to make my mind up if I need to have samples of all hand written signatures from the employees we are a company that has two international sites.
 
M

MIREGMGR

Some US FDA filings...510(k)s, for instance...require physical signatures with the master filed copy.

My experience is that US FDA has gone farther in acceptance of e-signatures than most other regulatory systems, so if you intend to market globally you may want to consider what your other regulators' expectations will be.
 

mihzago

Trusted Information Resource
If you are doing hand signatures then I don't believe there are any specific requirements for having signature samples. FDA does however have a requirement to have each employee hand sign an electronic signature certification for anyone using an electronic/digital signature. You also have to submit to the FDA a letter stating that your company is using electronic signatures.

You may need hand signatures for documents exchanged with vendors or customers, if they fall under your document control.

Another situation is when not everyone in your company has access to an electronic signature. I recently set-up a QMS at two companies, in which not everyone has access to electronic signature so I created somewhat of a hybrid system.
 
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