Personnel

All personnel using computer systems in GMP environments should be qualified to use those systems, have appropriate access within those systems, and work together to ensure compliance.

Text of Annex 11 Section 2 Personnel

There should be close cooperation between all relevant personnel such as Process Owner, System Owner, Qualified Persons and IT. All personnel should have appropriate qualifications, level of access and defined responsibilities to carry out their assigned duties.

Interpretation

Different groups within an organization using computer systems in regulated environment should work together to ensure compliance. All people who use computer systems with regulated environments should be qualified to perform their role. All people who use computer systems within regulated environments should have the appropriate access within the system to perform their jobs.

Compare this requirement with 21 CFR 11.10(i) Education, Training and Experience

Implementation

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

Frequently Asked Questions

Q: How do we document adequate training?
A: Before being granted system access, a user should be trained according to your company 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 GMP operations.

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