21 CFR §111.325

1. (a)You must make and keep records required under this subpart J in accordance with subpart P of this part.
2. (b)You must make and keep the following records:
   1. (1)Written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met;
   2. (2)Documentation that laboratory methodology established in accordance with this subpart J is followed.
      1. (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.
      2. (ii)The documentation for laboratory tests and examinations must include the results of the testing and examination.