You must make and keep records required under this subpart J in accordance with subpart P of this part.
You must make and keep the following records:
Written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met;
Documentation that laboratory methodology established in accordance with this subpart J is followed.
The person who conducts the testing and examination must document, at the time of performance, that laboratory methodology established in accordance with this subpart J is followed.
The documentation for laboratory tests and examinations must include the results of the testing and examination.
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