Recommendations for EU-compliant electronic signature systems for medical device documentation

Question

Our company is seeking recommendations for electronic signature systems that comply with EU requirements (no FDA considerations for now). We currently use a validated internal system (MatrixReq) for some technical documentation, but our SMQ is on Dropbox and we have been using DocuSign. Due to cost, we are considering switching to Adobe or other alternatives.
What electronic signature systems do others use for EU compliance? Are there cost-effective options that have passed tool validation and notified body audits?

Dr. Oliver Eidel · Accepted Answer

We're using the most basic 'Business' plan from signNow with a single user account for MDR purposes (not FDA). It passed both our tool validation and notified body audit, so it seems to be sufficient. The cost is reasonable, currently around USD 8/month.

Answer

We also use SignNow and haven't had any complaints from notified bodies so far.

Answer

Legal eSign is quite easy to use and, as far as I know, it's one of the cheapest options for a team. The main downside is that it takes a while to enter signature details for each document, but it's otherwise perfectly serviceable if you can live with that.

Answer

We use the Comala plugin for document approval. Our technical documentation is in Confluence, which already uses two-factor authentication. Approval via Comala is a one-click process and there's no need for traditional signatures. This works for us.

Answer

The EU equivalent to FDA 21 CFR Part 11 is Regulation (EU) 910/2014 for electronic signatures. Most services like DocuSign and Adobe Sign comply with both US and EU regulations, but more basic systems such as Comala in Confluence or even authorized merge requests in GitLab can also be compliant if they provide evidence of authorization. It's not about a visual signature, but about proving authorization.

Answer

If you're mainly interested in saving costs, you can even use something as simple as typing your initials in Google Docs. We've done this before at a few companies and it worked well. However, keep in mind that this approach is not FDA compliant.

Recommendations for EU-compliant electronic signature systems for medical device documentation

6 Answers

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