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Title 21 Part 111 → Subpart J → §111.325

Title 21 → Chapter I → Subchapter B → Part 111 → Subpart J → §111.325

Electronic Code of Federal Regulations e-CFR

Title 21 Part 111 → Subpart J → §111.325

§111.325   Under this subpart J, what records must you make and keep?

(a) You must make and keep records required under this subpart J in accordance with subpart P of this part.

(b) You must make and keep the following records:

(1) Written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met;

(2) Documentation that laboratory methodology established in accordance with this subpart J is followed.

(i) 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.

(ii) The documentation for laboratory tests and examinations must include the results of the testing and examination.