Quality Audits

Our Experience

Our auditors have broad range and depth of experience and can support a variety of audits including pre-clinical to clinical investigative (CROs), material suppliers, distribution and logistics firms, contract service organizations (CMOs, CDMO, etc.), as well as internal audits. Many of our auditors are certified by ASQ or other recognized certification bodies should your audit, either local or international, require a certified auditor.

Our Process

Our auditors use a standard process for planning and conducting audits that provides our clients with the needed assurance that vendors, systems, or processes have been rigorously vetted for compliance to applicable regulations and customer requirements. Whether your focus is GLP, GDP, GMP, GCP or GVP, our seasoned auditors deliver audit reports tailored to your needs.

Audit and Assessment Types

We provide audits across the spectrum of GxP businesses assisting clients at all stages of development, from pre-clinical through post-market approval. Typical audits that we specialize include:

Good Lbratory Practices (GLP)

  • Study Audits
  • Data Integrity
  • Vendor/Supplier Selection

Good Clinical Practices (GCP)

  • CROs
  • Investigator/Study Site
  • Data Integrity
  • Vendor/Supplier Selection
  • Intitutional Review Board
  • Mock Inspections

Good Manufacturing Practices (GMP)

  • CMOs/CDMOs
  • Contract Labs
  • Data Integrity
  • Vendor/Supplier Selection
  • Mock Inspections

Good Distribution Practices (GDP)

  • Contract Warehouses
  • Transportation Services
  • Data Integrity
  • Vendor/Supplier Selection
  • Mock Inspections

Quality Risk Management

Understanding where and how to implement risk management is critical to business success. Our team of quality and technical professionals have a strong understanding of the principles of ICH Q8, Q9 and Q10 and have used this experience and expertise to create and integrate QRM programs across the product lifecycle.

Specific Quality Risk Management (QRM) services include:

  • Educating and coaching your team on risk analysis tools (e.g., FMEA, PHA, FTA, HAZOP, Bowtie, AHP, Risk Ranking and Filtering)
  • Performing threat analysis to identify risks in your overall supply chain
  • Developing mitigation strategies for identified risks
  • Developing QRM programs including necessary policies, procedures, and supporting tools

You may be interested in the following article:

A Comparative Framework Between New Product and Legacy Product Process Validation

This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.