Who is this article for?Title 21, Part 11 of the Code of Federal Regulations sets out the requirements for the management of electronic records, and the use of electronic signatures within the United States Food and Drug Administration.Q-Pulse administrators responsible for managing Q-Pulse.
IT access will be required to implement this update.
In more practical terms, Part 11 requires FDA-regulated industries to implement controls for software and systems involved in processing electronic data. Such controls ensure the computer system is secure, contains audit trails for data values, and ensures the integrity of electronic signatures.
In addition to this, the standard also covers standard operating procedures within FDA-regulated industries. This addresses the IT infrastructure as a whole; data backup and security; as well as other aspects of computer systems that support records and signatures.
Q-Pulse delivers the appropriate technical controls for 21 CFR Part 11 compliance. More information on how Q-Pulse meets these controls can be found in the below table.
Note: Due to the number of controls included within the CFR standard, only a small selection has been chosen for illustrative purposes.
| Code | 21 CRF Part 11 Requirement | Additional Information |
|---|---|---|
| 11.10(d) | Limiting System Access to Authorised Users | How to Configure User Lockout |
| 11.100 (a) | Unique Electronic Signatures. | How to Configure Electronic Signatures |
| 11.10(d) | Limiting System Access to Authorised Users | How to Configure Session Timeout |
|
11.10(e)
11.10(j) |
Use of secure, time-stamped audit trails.
Adherence to, written policies that hold individuals accountable and responsible for action initiated under their electronic signature. |
What Activities Does the Q-Pulse Audit Log Track? |
For additional details, please review the Q-Pulse 21 CFR Part 11 Supplement.
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