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P H Carver

Publications and source records attributed to P H Carver.

2 recordsLinked to original sources

Check-off logs for routine equipment maintenance.

The regulatory requirement for appropriate routine instrument maintenance documentation is approached by laboratories in numerous ways. Standard operating procedures (SOPs) may refer to maintenance listed in instrument manuals, may indicate "periodic" performance of an action, or may indicate specific tasks to be performed at certain frequencies. The Quality Assurance Unit (QAU) task of assuring the performance of these indicated maintenance tasks can be extremely laborious if these records are merged with other analysis records. Further, the lack of written maintenance schedules often leads to omission of infrequently performed tasks. We recommend creation of routine maintenance check-off logs for instruments with tasks grouped by frequency of expected performance. Usage of such logs should result in better laboratory compliance with SOPs and the compliance can be readily monitored by QAU or by regulatory agencies.

Documentation↗

Quality auditing of chromatographic data.

We have developed a method for consistent, in-depth audit of the integrity of chromatographic records. The approach includes definition of the analyte, the method of analyte sample preparation and analysis, and the analyte concentration range. Acceptance criteria (if any) defined in the protocol or method are compared to the data. Run parameters are compared to those specified in the methodology. Certification of the standard is verified and the limit of quantitation for each run is identified and compared to data. Reasons for data discard and/or reassay are examined. If calculation software is not validated, representative calculations are recomputed and chromatograms are examined for attributability. These parameters are examined in addition to other Good Laboratory practice considerations such as sample identity, sample integrity, and transcription accuracy.

Chromatography↗