21 CFR 11.10(k): Document Control

Organizations that use FDA regulated computer systems must have a document control system. This document control system must include provisions for document approval, revision, and storage. They must also have defined procedures to use and administer the computer system.

Text of 21 CFR 11.10(k)

Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:

11.10(k) Use of appropriate controls over systems documentation including:

(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.

(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.

Interpretation

Document control is required for any documentation for this system, including SOPs and validation documents. This may be accomplished through a company’s existing document control procedures. There should be change control procedures that cover changes in system documentation. This may be covered by company document control procedures.

Implementation

An organization needs policies for creating compliant documentation and making changes to that documentation. All expired versions of SOPs or other compliant documentation should be retained for future regulatory review. All computer systems require a procedure describing the operation, maintenance, security, and administration for the system.

If you need more information or assistance with training on document control or assessing your document control system, please contact us to arrange consultation services.

Frequently Asked Questions

Q: Does every computer system require an operation and use procedure?
A: The use of every compliant computer system should be proceduralized. This can be documented in a system-specific SOP, or it can be documented with the associated procedure where the computer system is used.

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