This article applies to these plans:
Is DicksonOne 21 CFR Part 11 Compliant?
Is DicksonOne FDA Title 21 CFR Part 11 Compliant?
Yes, the DicksonOne system aids users of the system in complying with the reliability and integrity of data within the system in accordance with the U.S. Food and Drug Administration (FDA) 21 CFR Part 11 Guidelines.
DicksonOne offers a number of features that aid in a company's compliance including the following:
- Unlimited unique user accounts
- Secure access via unique User ID and User Password
- Password complexity and maintenance (e.g. password expiration) functionality
- Security via User Roles from Manage Access to Administrative functions
- A detailed inalterable audit log of all User actions and System events
- Inalterable Data storage
Warning There may be additional requirements of the organization utilizing DicksonOne to be fully compliant with all requirements of Title 21 CFR Part 11 compliance, including but not limited to, continuing education and internal Standard Operating Procedure (SOP).
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