21 CFR 11.10(f): Operational System Checks

FDA regulated computer systems should have sufficient controls or operational system checks to ensure that users must follow required procedures. For example, if a computer system regulates the release of a manufactured product, the computer system should not authorize the release until the appropriate Quality approval has been provided.

Text of 21 CFR 11.10(f)

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(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.

Interpretation

The system should not allow steps to occur in the wrong order. For example, should it be necessary to create, delete, or modify records in a particular sequence, operational system checks would ensure that the proper sequence is followed. Another example would be system checks that prevent changes to a record after it has been reviewed and signed.

Implementation

Document how the computer system prevents steps from occurring in the wrong order. If it is necessary to create, delete, or modify records in a particular sequence, explain how operational system checks will ensure that the proper sequence of events is followed.

If you need more information or assistance with training on operational system checks or assessing your systems to see if they have adequate operational system checks, please contact us to arrange consultation services.

Frequently Asked Questions

Q: Can you provide some examples of operational system checks?
A: An operation system check is any system control that enforces a particular workflow. For example, when approving a batch release, a system might require an electronic signature from manufacturing and quality control before the batch status can be changed to released. Another system may have a requirement that once an electronic signature is attached to a record, the record can no longer be modified. In this case, applying the electronic signature would trigger a control locking the record from future edits until the electronic signature is removed.

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