Pharma & Medical Device Audit Consultants | GForce

Audit and Compliance Support for Pharmaceutical & Medical Device Companies

Pharmaceutical and Medical Device Single Audit Program (MDSAP)

GForce provides GxP audit and inspection-readiness support for biotech, pharma, and medical device companies bringing products to market.

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

Frequently Asked Questions

Q: What types of audits are common in the life sciences industry?

A: Life sciences organizations may conduct quality system audits, supplier audits, internal compliance audits, and regulatory readiness assessments to evaluate processes and identify potential compliance gaps.

Q: When should a life sciences company hire an external audit consultant?

A: Companies may engage external audit consultants when preparing for regulatory inspections, assessing supplier quality, addressing compliance concerns, or obtaining additional expertise for internal audit programs.

Q: Can GForce Life Sciences provide experienced quality and compliance auditors?

A: Yes. GForce Life Sciences connects biotech, pharma, and medical device organizations with experienced audit and compliance professionals who understand industry-specific quality and regulatory requirements.

Q: What is the difference between an internal audit and a supplier audit?

A: An internal audit evaluates an organization’s own processes and quality systems. A supplier audit assesses whether an external vendor or supplier meets applicable quality, contractual, and regulatory requirements.

Q: How can audit consultants help prepare for regulatory inspections?

A: Audit consultants can help organizations evaluate documentation, identify potential compliance gaps, assess quality systems, and support corrective action planning before regulatory inspections.