A change control process represents the sum total of procedures undertaken to ensure that a change is fully validated and risk assessed before being put into routine use in the laboratory. Both CPA and EFI require that new processes, procedures and equipment must be validated before being implemented. In this context, validation is defined as the production of objective evidence to demonstrate that a process or procedure meets its intended purpose.
A change control process typically starts with a definition of the required change and the development of a change control plan. Key aspects of the change control plan include identification of who is affected by the change, establishing the level of validation required for the change and the acceptance criteria for the validation, carrying out a risk assessment of the proposed change, identifying which processes and SOPs need to be reviewed and updated, which staff need to trained or retrained and establishing a communications plan for communicating the change to the laboratory’s users.
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