Central Laboratory Audits /

Clinical Pathology Laboratory Audits

QC2 offers the following central laboratory / clinical pathology laboratory audits:

Safety Panels

Audits of clinical pathology/central laboratories to assess systems and facilities for compliance with industry best practice, Standard Operating Procedures, 21 CFR Part 11, CLIA, CAP, applicable state regulations, FDA guidances.  Assays typically include automated chemistry, hematology, urinalysis, special chemistry, and other contracted assays.  QC2 audits include assessment of instrument and assay validation.

Flow Cytometry

Audits of flow cytometry laboratories to assess systems and facilities for compliance with protocol requirements, CLIA, CAP, industry best practice, Standard Operating Procedures, 21 CFR Part 11, and applicable FDA guidances.  Assays include immunophenotyping and client-specific assays.  QC2 audits include assessment of instrument and assay validation.

Molecular Diagnostics

Audits of molecular diagnostics laboratories to assess systems and facilities for compliance with protocol requirements, CLIA, CAP, industry best practice, Standard Operating Procedures, 21 CFR Part 11, and applicable FDA guidances.  Assays include detection of viruses as well as gene rearrangements or client-specific assays.  QC2 audits include assessment of instrument and assay validation.

Cell-Based Assays

Audits of cell-based assays laboratories to assess systems and facilities for compliance with protocol requirements, CLIA, CAP, industry best practice, Standard Operating Procedures, 21 CFR Part 11, and applicable FDA guidances.  Assays are typically client-specific.  QC2 audits include assessment of instrument and assay validation.

Specialty Diagnostics

Audits of specialty diagnostic laboratoriesto assess systems and facilities for compliance with protocol requirements, CLIA, CAP, industry best practice, Standard Operating Procedures, 21 CFR Part 11, and applicable FDA guidances.  Assays are typically commercially available and kit-based but may also be client-specific.  QC2 audits include assessment of instrument and assay validation.

QC2 audits are customized for your specific project and budget needs.  We can provide assistance with all aspects of your projects, including audit plan consulting and development, audit scheduling, conduct, and reporting, and audit follow-up services (e.g., review of audit responses).  We conduct both general qualification audits and in-study audits. Many of our audits can be conducted remotely, helping our clients to maintain their audit programs during this unprecedented time.