Selected Auditing Services

Lucid routinely provides independent auditing of real-time laboratory analysis.  Often, the purpose is two-fold.  The client gets independent verification of accuracy and compliance for critical analyses.  Also, the client gets a written evaluation of the techniques of the analyst.

This includes proper use of glassware and equipment, transfer techniques, and the general level of proficiency of the analyst for that method and matrix.  Our client then uses these reports to augment personnel files and to direct further training.

For the verification portion, the auditor watches all portions of sample retrieval, sample preparation, standards preparation, and instrument setup and operation.  After the results have been reported by the analyst, the auditor then reviews the instrument printouts and laboratory notebook entries and recalculates all results and verifies the accuracy and compliance of the final analytical results.

●   One example of this type of audit is the GLP analysis of fentanyl in a proprietary film.

●  Our auditor observed all aspects of the execution of eight different analytical methods.

●  Methods were performed by four different analysts.

●  Verified preparation of standards, sample preparation, instrument setup and operation.

●  Methods for this project included Karl-Fischer, HPLC, GC/FID, disintegration and gel permeation chromatography.

●  Audit report included all details of the audit, which included the methods observed, the samples analyzed and a list of findings and observations associated with the analyses.