(1) In order to demonstrate data traceability, laboratories must:

(a) Be able to recreate final sample results by means of records in entirety;

(b) Document proper storage of any chemical, reagent, and/or media used by an analytical method;

(c) Document proper storage of samples and samples extracts as required by the specific analytical method and/or regulation;

(d) Document that all temperature-based equipment such as a refrigerator, oven, or incubator is within control. When electronic record keeping equipment is used, these records must be appropriately monitored by lab personnel to verify that temperatures meet relevant method and regulatory requirements;

(e) Keep a log for any and all instruments, including documentation of installation, setup, maintenance, and removal from service; and

(f) Document proper preparation and QC of chemicals, reagents, and media used in support of the analyses.

(2) When records are handwritten, they must be in indelible ink and comply with the relevant method requirements and include the date and time(s) of reading, temperature(s), and technician's initials.

(3) Unmonitored use of continuous data-loggers is not an acceptable substitute when methods and/or regulations require temperature checks. Use of electronic record keeping equipment is allowed when:

(a) The equipment can demonstrate the accuracy and precision required by the applicable method and/or regulations;

(b) It includes the date and time the record was captured, using a fully traceable and secure format; and

(c) It is not being used on an incubator used for analysis of samples for microbiology parameters.