Medical Device & Pharmaceutical Auditing

Pharmaceutical Audit Services

Pharmaceutical and Medical Device Single Audit Program (MDSAP)

GForce Life Sciences works with pharmaceutical, medical device and diagnostic organizations to achieve certification and compliance with requirements specified by the FDA and other global regulatory authorities.

Pharmaceutical/Biotechnology: GMP, GCP, GCLP, GLP, ISO 9001, ISO 17025, QSR, FDA21 CFR

Medical Device/Diagnostics: GMP, ISO 9001, ISO 13485, ISO 14971, ISO 17025, QSR, FDA 21 CFR, EU MDR, IVDR, IEC and MDSAP

Pharmaceutical/medical device audits uncover inefficiencies and regulatory concerns of your organization, internal processes or even product quality. If regulations and GxPs are not satisfied, it could lead to the loss of certification or even a product recall. In-depth Quality Management System (QMS) audits are the best tool for discovering how well your processes (and those of your suppliers) perform. These QMS audits go beyond surface findings to examine process interactions and efficiency. They give your company a clear view of what is happening and the information you need to improve overall performance.

Why Outsource Quality or Regulatory Compliance Audits?

Companies chose to outsource some or all of their internal and/or supplier pharma audits to GForce Life Sciences for the following reasons:

Objective Assessments

Our auditors provide a fresh, outsider view of your processes. We can also augment your in-house team when you need auditors independent of the area to be audited.

Specialized Expertise

Outsourcing allows you to draw upon a network of specialists in industry-specific standards and relevant regulations. Our auditors have 15+ years of industry experience.

Value-Added Audit Findings

Our auditors provide an in-depth assessment of your company’s processes to identify strengths and weaknesses. If we find nonconformances, these pharmaceutical auditing experts will help you develop and implement effective corrective actions.

GForce Areas of Audit Expertise

  • Baseline or Gap Assessment
  • Pre-Assessment Audits
  • Mock FDA Inspections/Audits
  • Internal Audits
  • Subcontractor, Supplier or Distributor Audits
  • Auditor Training
  • FDA Inspection Readiness
  • Desktop/Remote Audit

“When GForce delivers, it is quality vs. quantity, but the candidate quality is exceptional.”

— GForce Client

Learn how GForce Life Sciences can help accelerate your growth.