Hello all!

Our company, a 12-employee software company, is thinking about integrating a CRM in order to facilitate customer support operations. However, we want to make sure that we comply with 21 CFR part 11 of the FDA on electronic records and electronic signatures. Anybody has experience with that process? I have seen software on document control advertising about being compliant with this part of the standard but not much information about that on CRM.

Furthermore, should I look for evidence that the software has such characteristics or is there a validation process to undergo to prove that we comply with it? Any registration required?

Thanks for your help... :o

Just so we are speaking the same language, do you mind clarifying what CRM stands for?:D

Essentially, when the software is compliant, they say so. :tg: The software is designed with audit trail, security levels, electronic signature, security from tampering, etc. That is a lot of money in development, so they will advertise it so individuals looking for that will know their product has those features.

Sorry for the acronym: CRM = Customer Relationship Management software.

Basically, the CRM would, in our case, deal with customer satisfaction, customer complaints...

These types of software are very dependent on the configuration the owner will do since the workflows are configurable. So your telling me that the audit trail option would ensure compliance to the standard? I thought the compliance to that aspect included complete validation of the "equipment around it" as well (server, backup system...). Since the only aspect we want to keep in electronic format for now are the customer-related docs, I am trying to identify the best way to do it.

Thanks...

The implication of 21 CFR Part 11 shall encompass wider scope in case of Quality Management or any Manufacturing Systems and applicable for every element of the application, but for other applications such as CRM, or Training software Systems, 21 CFR Part 11 shall impact only selected workflows and data elements.

So what are you suggesting is the best way to go? (if "only" the documents/data are considered within the scope for CRM)

Also, would you say it is acceptable from an FDA point of view if:
- Complaints are recorded and handled electronically through a CRM (validated workflow of course)
- Monthly, reports are generated and a meeting is held during which complaints status and evaluation are reviewed

Would you say this meet the requirements? (considering minutes of that meeting are signed and recorded in the paper-system)

For the 21 CFR Part 11 status, have a word with your software supplier as well - they will be able to help you out.