People create records, make decisions, perform reviews, investigate problems and execute the processes represented within the software. Training therefore needs to be treated as a core implementation workstream.
A useful pre-audit programme should identify training needs, focus on actual responsibilities, test understanding, examine data integrity, reinforce escalation processes and review training records
Training is a fundamental component of clinical trial readiness. It should establish the knowledge and practical competence required for personnel to perform their assigned responsibilities consistently and in accordance with the protocol,
A quality agreement is not simply a commercial contract with additional quality language. Its purpose is to translate applicable Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice, and other relevant quality requirements