In accordance with 21 CFR Part 11, a closed electronic records system must do all EXCEPT:

According to 21 CFR Part 11, Subpart B, Section 11.10, "Controls for closed systems," the system must be able to generate accurate and complete copies of records in both human-readable and electronic form suitable for inspection. However, the regulation does not explicitly mandate that the system must be able to print a complete paper copy. A human-readable format could be a digital file (e.g., a PDF) displayed on a screen. The other options—maintaining accurate records, generating audit trails, and customizing access—are all specific requirements for closed systems outlined in this section.

A. This is incorrect because 21 CFR §11.10(c) explicitly requires the "Protection of records to enable their accurate and ready retrieval throughout the records retention period."

B. This is incorrect because 21 CFR §11.10(e) mandates the use of "secure, computer-generated, time-stamped audit trails to independently record...actions that create, modify, or delete electronic records."

C. This is incorrect because 21 CFR §11.10(d) requires "Limiting system access to authorized individuals," which necessitates the ability to customize access rights.

1. U.S. Food and Drug Administration (FDA). (2023). Title 21 Code of Federal Regulations (CFR) Part 11 - Electronic Records; Electronic Signatures.

Section 11.10(b): Specifies the requirement for the "Ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency." This does not mandate printing.

Section 11.10(c): States the requirement for "Protection of records to enable their accurate and ready retrieval throughout the records retention period."

Section 11.10(d): Requires "Limiting system access to authorized individuals."

Section 11.10(e): Mandates the "Use of secure, computer-generated, time-stamped audit trails..."

2. Harvard Catalyst | The Harvard Clinical and Translational Science Center. (n.d.). Regulatory Training: 21 CFR Part 11.

In its breakdown of Subpart B - Electronic Records, the courseware explains that systems must generate human-readable copies, but clarifies this is for agency review and does not stipulate the physical medium, distinguishing it from a mandatory print function. It emphasizes the requirements for access controls (§11.10(d)) and audit trails (§11.10(e)).

3. University of California, San Francisco (UCSF), Office of Research. (n.d.). Guidance: 21 CFR Part 11.

The guidance document outlines the key controls for closed systems, explicitly listing audit trails, access controls, and record protection for retention as mandatory. It describes the output requirement as generating "human-readable" copies, consistent with the FDA's text, without specifying a print requirement.