GAMP 5 - Good Automated Manufacturing Practice
Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 6.1.3: 6.1.3 Training

Personnel involved in developing, validating, operating, supporting and using computerized systems are suitably educated, trained and experienced for their roles, training needs are identified for each role and for new or changed systems and processes, training is delivered before access or responsibility is granted, and records of training and competence are retained. Training content is targeted to the audience and scaled to the principles that need reinforcing, including data integrity reporting for all users and human factors and root cause investigation for specialists, rather than repeating generic material.

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What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

ISO 13485:2016 · 1 control

  • 6.2 Human resources

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Chapter 6: Regulated company activities (governance and system-specific activities) – GAMP 5 - Good Automated Manufacturing Practice

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.