Application Note – GLP N.2 – “Technical Records: How much information is sufficient?”
“Technical Records: How much information is sufficient?”
ISO 17025 and GLP require maintaining adequate technical records. But what needs to be recorded? Section 4.13.2.1. of ISO 17025 requires that: “The laboratory shall retain records of original observations, derived data, and sufficient information to establish an audit trail”.
The records is a tool: “to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original”.
• Laboratory sampling receipt
An unique identification label is necessary so that analysis of that sample can be tracked throughout the analytical process.
• Chain of custody
It is important to record a chain of custody from the time a laboratory takes responsibility for a sample until the results are reported to the customer. This is expecially important for GPL ad forensic analyses.
• Sample storage conditions
If the sample is stored at not the proper temperature, the analysis will not be valid. Therefore additional records are required for refrigerator or freezer where the sample is stored before analysis.
• Sample preparation and adopted analytical method
Records should show who performed the analysis, what equipment was used, which method was used.
• Staff training
The training records should show that the analyst is authorized to perform the analysis.
AOAC International Guidelines – ALACC Guidelines says: “Records shall include verification that the effective-ness of the training action has been evaluated”.
“Laboratory Management shall retain records that demonstrate that each individual has the required knowledge, skills, and abilities to adequately perform their assigned tasks”.
• Maintenance and Calibration of instrumentation
Calibration records not only include an account that this step has been performed, but must show that it was performed properly and by an accredited calibration provider or properly trained in-house staff.
• Handling Errors
When original data is corrected, it must never be erased or made illegible. ISO/ IEC 17025:2005 requires that: “it be crossed out with the corrected value entered next to the original and signed or initialed by the person making the correction”.
• Retaining records
ALAAC Guide Lines says: “Record retention policies shall be consistent with the customer’s requirements and the requirements of the laboratory”. FDA requests that records should be retained until 2 years after FDA approval or 5 years after FDA submissions.
• Conclusions
Maintaining adequate data is important in establishing an audit trail. By reviewing these records, it is possible to recreate what happened in the laboratory.
