Compliance matrix
- Last UpdatedAug 14, 2025
- 2 minute read
The following table identifies which type of control is needed to comply with specific requirements defined in the Part 11 regulation. An 'X' in the Procedural or Technological column indicates the control applies for the requirement listed in that row. Sections 3 and 4 of this guide are structured to mirror the regulation and present the reader with information and specific technical methods or options available to support Part 11 compliance. In each subsection within Sections 3 and 4, the specific regulation text being addressed is presented to aid in the interpretation and application of this guide (shown in bold italics).
|
21 CFR 11 Requirement |
Procedural |
Technological |
|---|---|---|
|
Subpart B 11.10 |
X |
X |
|
Subpart B 11.10 (a)* |
X |
X |
|
Subpart B 11.10 (b)* |
X |
|
|
Subpart B 11.10 (c)* |
X |
X |
|
Subpart B 11.10 (d) |
X |
X |
|
Subpart B 11.10 (e)* |
X |
X |
|
Subpart B 11.10 (f) |
X |
|
|
Subpart B 11.10 (g) |
X |
X |
|
Subpart B 11.10 (h) |
X |
|
|
Subpart B 11.10 (i) |
X |
|
|
Subpart B 11.10 (j) |
X |
|
|
Subpart B 11.10 (k) |
X |
X |
|
Subpart B 11.10 (k) 1 |
X |
X |
|
Subpart B 11.10 (k) 2* |
X |
X |
|
Subpart B 11.30* |
N/A** |
N/A** |
|
Subpart B 11.50 (a) |
X |
|
|
Subpart B 11.50 (a) 1 |
X |
|
|
Subpart B 11.50 (a) 2 |
X |
|
|
Subpart B 11.50 (a) 3 |
X |
|
|
Subpart B 11.50 (b) |
X |
|
|
Subpart B 11.70 |
X |
|
|
Subpart C 11.100 (a) |
X |
X |
|
Subpart C 11.100 (b) |
X |
|
|
Subpart C 11.100 (c) |
X |
|
|
Subpart C 11.100 (c) 1 |
X |
|
|
Subpart C 11.100 (c) 2 |
X |
|
|
Subpart C 11.200 (a) |
X |
X |
|
Subpart C 11.200 (a) 1 |
X |
X |
|
Subpart C 11.200 (a) 1.i |
X |
X |
|
Subpart C 11.200 (a) 1.ii |
X |
X |
|
Subpart C 11.200 (a) 2 |
X |
|
|
Subpart C 11.200 (a) 3 |
X |
X |
|
Subpart C 11.200 (b) |
N/A*** |
N/A*** |
|
Subpart C 11.300 |
X |
X |
|
Subpart C 11.300 (a) |
X |
X |
|
Subpart C 11.300 (b) |
X |
X |
|
Subpart C 11.300 (c) |
X |
|
|
Subpart C 11.300 (d) |
X |
X |
|
Subpart C 11.300 (e) |
X |
* These sections are part of the enforcement discretion defined in the Part 11 Guidance for Industry
** Open systems are outside the scope of this guide
*** Biometric signatures are outside the scope of this guide