Compliance and Quality Assurance QA

Users are provided with clear operating instructions, manuals, and SOPs to enable them to perform assigned system functions. 

Sufficient training to clarify these instructions is provided to users. 

Users able to meet operation requirements are eligible to perform these LIMS functions. 

An additional QA unit monitors LIMS activities as described in the GALP guidelines. The QA unit s responsibilities primarily are inspection, audit, and review of the LIMS and its data. An organizational plan is developed to define lines of communication, reporting, inspection, and review of the LIMS and its data. The QA unit must be entirely separate from and independent of the personnel engaged in the direction and conduct of a study and should report to laboratory management. 

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