Selected Auditing Services

Lucid was tasked to perform an audit of a vendor laboratory that performed approximately 200 sample analyses.  The laboratory performed two analytical methods, one of which was cross-validated using a different matrix.

We performed the audit by reviewing the documentation of the laboratory’s general systems and facility.  This included sample receipt, storage, custody, balance and thermometer calibrations, and employee qualifications.  We then audited the documentation specific to the study in question.  This included method validation, sample preparation and analysis, data processing and the accuracy of the final report.

After the conclusion of the on-site audit, we prepared a draft written report with all issues, which was reviewed by the laboratory and the client.  Working with the laboratory, we reviewed their responses to the audit, which enabled us to resolve all issues and to provide documentation to our client supporting the compliance and accuracy of the analysis work.

●  Lucid performed a Facility Audit of PPD Development, which continued to perform GLP analyses for a variety of our client’s subsequent projects

●  Performed a Technical Audit of a recently completed GLP study to determine accuracy and compliance of the final analytical report.

●  Facility audit included 16 different subsections of 21 CFR Part 58.

●  Audit included examination of all recent FDA 483 reports.

●  Technical audit included a full review, and a sub-sampled reprocessing of the raw results to determine the accuracy of the report.

●  Technical audit also included ancillary items to determine whether GLP requirements were met during the dates of analysis.

●  Follow-up interaction with laboratory results in the successful resolution of all issues.