User Access Controls

Definition

User access controls are the role-based permissions within an EBR system that restrict what actions a given user can perform, such as viewing, entering, editing, or approving data, based on their assigned role and responsibilities. Access controls are a foundational requirement under 21 CFR Part 11 and similar regulations.

Benefits

Properly configured, role-based access controls ensure operators, reviewers, and approvers each have exactly the level of system access appropriate to their job function, preventing, for example, a production operator from being able to approve their own batch record entries, which would undermine the integrity of the review process.

Use Case

An EBR system is configured so that production operators can enter data but cannot modify entries after submission, while a separate QA reviewer role has the ability to review and approve, but not directly edit the same entries, maintaining segregation of duties throughout the batch record lifecycle.

Frequently Asked Questions (FAQ)

Related Terms

• 21 CFR Part 11
• Audit Trail
• Electronic Signature (e-signature)