Golden Rules Remain Unchanged

Plan and monitor validation adopt a proactive project management style. 

Document validation, including collating raw data as supporting evidence ensure everything is reviewed and approved. 

Implement a regime of change control covering projects and operational use of the computer system. 

Develop system specifications with testing in mind and test using preapproved qualification protocols. 

Use the approval of summary validation reports to authorize the use of a computer system. 

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