SIR #: 416
Section: V1M2, Section 126.96.36.199 (c)
The standard as written states, "Records shall be maintained on standard, reference material, and reagent preparation. These records shall indicate traceability to purchased stocks or neat compounds, reference to the method of preparation, date of preparation, expiration date and preparer's initials."
Does the laboratory need to have a single document that includes each of these items or can the laboratory's record keeping system allow multiple records/documents (including electronic) that contain or reference the required items? Or more simply, can the Standard be interpreted to mean that "reference to" can be applied to the string/list of items, such as the record may include a "reference to" the method of preparation, "reference to" the date of preparation, "reference to" the expiration date and "reference to" preparer's initials?
TNI FINAL RESPONSE:
The standard does not state a requirement for a single record. There are many ways a laboratory could maintain the records listed in section 188.8.131.52.c, including the system described in the interpretation request. The record-keeping system is acceptable if it meets the record requirements in 4.13.1.