Question 1

What is 21 CFR Part 11 document control?

Accepted Answer

21 CFR Part 11 is the FDA regulation that sets the conditions under which electronic records and electronic signatures are trusted as equivalent to paper records and handwritten signatures. Part 11 document control is the set of system controls and procedures that keep controlled electronic documents trustworthy: secure audit trails, limited system access, authority checks, electronic signatures linked to their records, and retained version history.

Question 2

Is Assyro DMS 21 CFR Part 11 compliant?

Accepted Answer

No software is Part 11 compliant on its own, and FDA does not certify software for Part 11. Assyro DMS is Part 11-capable. It provides the technical controls Part 11 expects. Your organization achieves compliance by validating the system for its intended use and operating it under written procedures, training, and account controls.

Question 3

Which Part 11 controls does Assyro DMS provide?

Accepted Answer

Assyro DMS provides audit trails that record who did what and when, access controls that limit who can edit, review, and approve, electronic signatures that show the signer and the reason for signing, signatures that stay linked to the exact record version they approve, and version history that cannot be silently altered.

Question 4

What is the customer responsible for under Part 11?

Accepted Answer

The regulated company is responsible for validating the system for its intended use, writing and following SOPs, training users, managing user accounts and signature credentials, and holding people accountable for actions taken under their electronic signatures. Assyro provides the system controls and documentation your quality team uses to complete that work.

Question 5

How do audit trails work in Assyro DMS?

Accepted Answer

Each create, edit, review, approval, and status change on a controlled document is recorded with the user and time. The history cannot be silently altered, so an inspector can see the full record of a document from draft to approval without anyone reconstructing it.

Question 6

Does Assyro DMS also support EU Annex 11?

Accepted Answer

Yes. The same audit trail, access, signature, and version controls map to EU GMP Annex 11 expectations for computerised systems. As with Part 11, Annex 11 compliance depends on your validation and procedures.

Question 7

How does Part 11 relate to ALCOA+ data integrity?

Accepted Answer

ALCOA+ describes what trustworthy data looks like: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. Part 11 controls such as audit trails, access limits, and signatures linked to records are how an electronic system keeps documents attributable and original over time.

Question 8

Where can I learn more about Part 11 requirements?

Accepted Answer

Our 21 CFR Part 11 compliance guide on the Assyro blog covers the regulation section by section, including validation, audit trails, and electronic signatures. Use it alongside FDA's own Part 11 guidance on scope and application.

Document Control That Supports Your 21 CFR Part 11 Program

System Controls a Part 11 Program Relies On

Audit Trails on Every Controlled Record

Electronic Signatures Linked to the Record

Access Control by Role

Version History You Can Compare

Part 11-Capable Software, Your Validated Process

Controls Mapped to Part 11 and Annex 11

Validation Support for Your Quality Team

Guides for your next decision

Questions About 21 CFR Part 11 Document Control

See Part 11 Document Control in Assyro DMS.