Is Monday Part 11 Compliant?

Platform discussions
1

Hi everyone,

Does anyone know if Monday is Part 11 compliant? I want to create forms to be used by our field team when completing installation and applications training.

Cheers,
-Ed

2

Hey Ed,

Are you able to specify what you are referring to regarding Monday part II?

In terms of compliance, please see our dedicated trust center: Trust Center | monday.com

We also encourage you to look into our FAQs: FAQs - Security and Privacy

Let me know if you have any specific questions :slight_smile:

3

Hi Bianca,

Part 11 is a US Code Of Federal Regulation that applies to certain industries such as medical device or pharmaceutical. When these industries use certain systems for work processes that are applicable to Quality System Regulations, those software systems have to meet a certain level of security and validation.

Here are some links…

Federal link - HERE

Guide link - HERE

5

Thank you for clarifying, Ed.

I’ve been in discussion with our Security team internally who clarified that due to the thousands of global customers are work with, we focus our attention on top industry standard certifications for information security. As provided, you can see our Compliance & Certifications section in our Trust Center.

In addition, monday.com’s platform is not intended for the processing of PHI data or any data that is protected under special legislation and requires unique treatment, unless client and monday.com separately enter into a HIPAA Business Associate Agreement. For more information please see section 3.3 of monday.com’s ToS: Terms of Service, and please find the BAA at: HIPAA Business Associate Agreement - monday.com Legal Portal.

I hope this helps to some extent!

6

Part 11 isn’t for PHI. Its a requirement for documenting work activities in the medical device and pharmaceutical industries. We will write up our own.