GLP QA and QC Audits

RESQ supports Clients with GLP compliance through periodic and event-driven audits at a frequency determined by the Client based upon specific laboratory needs. GLP audits support repeatability and reliability of the Client’s data integrity within or across multiple laboratories. RESQ works with the Client to establish master Audit Plans and Agenda to cover all elements of GLP Audits.

RESQ can perform audits of the following:

  • Organization and personnel – adequacy of training and skill sets.
  • Laboratory equipment – Scheduled maintenance audits and maintenance/use records review.
  • Testing facility operations – Existence, quality, presense, and configuration. Execution and control of SOPs.
  • Quality control program – Comprehensiveness and currency of a well-documented QC plan and program, testing, and QC logs.
  • Records and reports – presence and adequacy of systems to retain clinical trial data records and reports as required for troubleshooting or study reconstruction. Proper organization, retention and readability of reports.
  • Specimen transport and management – Existence, adequacy, and execution of well-documented procedures for the collection, receipt, labeling/recording, and movement of specimens.
  • Personnel safety – Existence and adequacy of safety policies (IAW OSHA, etc.) covering use of safety equipment, hazardous material handling, incident reporting, disaster recovery, safety awareness and training, and standard facility safety issues.
  • Laboratory information systems – Audit SOP and other use documentation, data quality, interoperability with other systems, access authorization, system training, and disaster recovery/business continuation plans.
  • Quality management – Existence and adequacy of a documented QM program with defined procedures to monitor, identify/analyze, and correct problems. Audit track record of issue management including report out documentation of corrective actions. Assess currency of the QM program and proof of internal auditing, periodic evaluation and update.