Part 11 of Title 21 of the Code of Federal Regulations establishes regulations that govern electronic records and signatures on documents created, maintained, retrieved, transferred, or submitted pursuant to any United States Food and Drug Administration (“FDA”) regulations or submitted to the FDA.

• Relevant Industries include

• Pharmaceutical manufacturers

• Biotechnology companies

• Medical device manufacturers

• Clinical research organizations (CROs)

• Healthcare providers and hospitals

• Laboratories and research institutions

• Food and beverage manufacturers

• Cosmetics manufacturers

PandaDoc provides 21 CFR part 11 compliance for electronic signatures by requiring signers to meet security standards set by this regulation and then properly documenting the signatures with required data for all parties to verify.

Electronic signatures that are 21 CFR Part 11 compliant must satisfy a number of different requirements. These include:

• The printed name of the signer

• The date and time the signature was executed

• The meaning of the signature (such as review, or approval)

• A unique user ID

• Digitally adopted signature

Yes, PandaDoc can provide the ID verification, the unique user ID, and all other required information on an electronic signature to ensure that it meets CFR Part 11 compliance. For a closer look at how 21 CFR Part 11 compliance works with PandaDoc, request a software demo with our team today.

The US and EU versions of PandaDoc are similar and equally secure. However, the versions are independent and isolated installations of the application. This means that if you have a PandaDoc account within the US, PandaDoc EU would not know about this account and would not have any information.

We keep the environments isolated in order to provide data residency to our customers. The following information is stored and processed in bounds of chosen region:

• PandaDoc Account’s Configuration

• Documents (PandaDocs, Templates and PDF copies of signed documents)

• Images Assets

• Document’s Texts, Attachments and Metadata

• In-document communication (Comments)

• Billing Information (Billing Addresses, Account Names, Subscription Details)

• PandaDoc Contacts

• Forms (including information your customers enter)

• Content Library Items

• Catalog Items

• PandaDoc Inboxes (you account members and your customers)

• Reporting and Document’s Analytics

Yes. The following information, regardless of which version of PandaDoc is chosen, is stored (and transferred to the US):

• Your communication with PandaDoc representatives, specifically our Customer Support team and all interactions with this team. In order to provide best in class support for our customers PandaDoc remains to be a global company, this means that our representatives are hosted across the globe and would be happy to help as soon as possible. Unfortunately, we can’t isolate our communications in one particular region. This means that information such as video calls, account information, customer ticket information can be accessed and transferred to the US.

• The transactional analytical information about your account that helps us to make PandaDoc a better application for you.

• 3rd Party integrations that our customers enable within their account could transfer data outside of your chosen PandaDoc application location. This is dependent on the specific integration and the 3rd party provider. If you have questions on your specific integrations, let us know and we will help you.

• Interactions with our Sales team, basic sales contact information, and the initial contractual sales documentation.

Unfortunately, for security purposes, this is not possible. You cannot transfer data from PandaDoc one data center to another. If you’ve chosen the US server, you will be able to have a separate account in the EU with the same email address of the account owner, but it would be a second account that does not share neither license, nor any information with the first one — you’ll need to set up and maintain it separately, which gives you full control over your data residency.