Field QA components

In-life or critical phase audits must be completed in a timely and efficient manner. They must not detract from the conduct of the study or interfere with the execution of critical activities within the study. However, QA must be able to clearly determine the actual progress of the study. Audit reports must clearly identify the actual findings of the audit. The reports must be relayed to the Study Director and to study management in a timely manner. If deviations occur or if minor findings are reported, they must 

In 1989, the field portion of residue chemistry studies began to be regulated under the ERA S Good Laboratory Rractice Standard (GLRS) (40 CFR Rart 160). At that time the only feasible means of collecting and reporting field data was via paper. Each sponsor 

The records required for field residue study authentication are the same records that would be required to reconstruct the study. Although this total volume of information is a necessary part of the GLP study record, the field summary report is a small fraction of that record. The field summary report is simply the information the EPA reviewers wish to see as they consider the data and determine how well they represent the crop situation for which the pesticide tolerance is being requested. At the current time, the field summary report should contain the information requested on pp. 48 and 49 of OPPTS 860.1500. The summary report for each test site in a study will typically form an appendix in the final study report. This information must be accurately extracted from the raw data notebook or field record and must be audited by 

Office of the Federal Register National Archives and Records Administration, 40 CFR Parts 150 to 189, Protection of Environment, Revised as of July 1, 1999, US Government Printing Office, Washington, DC (1999). 

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