21 CFR 11.10(i): Education, Training and Experience

Individuals who use FDA regulated computer systems should have the appropriate education, training, or experience to operate the system.

Text of 21 CFR 11.10(i)

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(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.

Interpretation

All users (including system administrators) must be trained before they are assigned tasks in the system. All users should be appropriately trained on the process regulated by the computer system.

Implementation

Describe any training that a person should receive before they are allowed to use this system. Include relevant SOPs, STMs, etc.

If you need training on 21 CFR 11 or validation, would like assistance assessing your training system systems to see they are compliant, or would need to proceduralize your training program, please contact us to arrange consultation services.

Compare this requirement with Annex 11 Section 2., Personnel.

Frequently Asked Questions

Q: How do we document adequate training?
A: Before being granted system access, a user should be trained according to your companies procedures for training. This training should be documented and retained. In addition, an organization should retain a CV for all employees and contractors who perform GxP operations.

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