1.7.3 GLP Documentation

Documentation is the operational backbone of any GLP system, since a study that is not fully and contemporaneously documented cannot, in the eyes of a...

Documentation is the operational backbone of any GLP system, since a study that is not fully and contemporaneously documented cannot, in the eyes of a regulatory auditor, be considered to have occurred as claimed. A GLP-compliant study generates several categories of documentation that must remain internally consistent and fully traceable. The master schedule provides an institution-wide overview of all ongoing and completed GLP studies, allowing the Quality Assurance unit to plan its audit activities. The study protocol, approved and signed before the study begins, defines the objective, design, materials, and methods in sufficient detail that an independent scientist could reproduce the work. Raw data records — instrument printouts, laboratory notebooks, and electronic data files — must be attributable, legible, contemporaneous, original, and accurate, a standard frequently summarised by the acronym ALCOA. Any correction to raw data must be made by striking through the original entry (never obliterating it), initialling, dating, and, where required, explaining the reason for the change. Finally, the final study report integrates all raw data into a coherent narrative, is reviewed and signed by the Study Director, and is archived together with the underlying raw data for a period typically not less than ten years, ensuring that the study can be reconstructed and re-audited at any point during that retention period.