Monograph-Form Testing Record

Equipment and Utensils (Part D)

Laboratory Operations (Part J) cGMP SOP Templates and Supporting Documents

Monograph-Form Testing Record

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Published: Thursday, April 1, 2010

This is an example of a “monograph” based laboratory documentation system. The DCM issues one copy of the testing record for each sample to be tested and assigns the copy a unique control number. This prevents analysts from making uncontrolled copies of the test record and falsifying data to fit preconceived requirements, thereby helping to ensure data integrity.

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