Valuable analysis, delivered on time

Get the audit you need to ensure compliance and maintain quality.

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You’ve set your audit goals. Now it’s time to meet them.

What you need
Get the analysis you need to follow through on your audit plan.

When you need it
You’ve got a deadline. We can ensure that you meet it.

With all the details
Get the full scoop on vendors and contract manufacturers.

For all audit types
Cover internal requirements, such as CAPA, to full quality management system audits.

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Here’s what quality audit managers are saying

Comprehensive...

QAC provided me with full audit support from audit planning to a comprehensive audit report and completed it within the established timeline.

Mark
Pharma, Associate Director, Quality Systems

Nice job QAC...

Nice job QAC! Your audit help us complete our vendor audit schedule on time this year!

Laura
Pharma Audit Manager

Expertise to the rescue

Hiring and training auditors is expensive and time consuming. Save money and ensure quality with an auditor who can hit the ground running. QAC is a:

  • Certified Quality Auditor (CQA) ASQ
  • ISO 9001:2015 Certified Auditor
  • ISO 13485:2016 Certified Auditor
  • 20-year expert in pharmaceuticals, biotechnology, and medical devices

Complete and compliant

Avoid the costs, risks, and business consequences of late or incomplete audits. Our reports address every necessary quality metric, including all FDA and EU standards.

Assess vendor risk

Let’s create a risk assessment that you and your team can rely on. QAC can help you gauge the risk of your vendors by creating a comprehensive report that addresses each and every quality benchmark.

You’ll know for sure what you’re getting yourself into. And you’ll get all the data you need, when you need it.

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Our complete suite of quality audits

Pharmaceutical, biotechnology, and medical device industry audits

  • Quality systems audits
  • Supplier and vendor quality audits
  • Remote vendor qualifications and assessments
  • Computer systems validation audits
  • 21 CFR Part 11 Compliance Audits
  • Contract Manufacturing Organizations (CMO's)

Internal process audits

  • Device design and control
  • Supplier quality
  • Customer care (CRM)
  • Field service
  • CAPA
  • Compliance
  • Clinical
  • Regulatory
  • Change control
  • Production
  • Quality systems
  • Environmental systems

21 CFR Part 11 audits

  • Electronic records
  • Electronic signatures audits focused on Distributed Control Systems for large-scale biopharmaceutical manufacturing
  • Primary Logic Controllers (PLCs) and Laboratory automated systems (Empower for HPLC systems)

Third Party Logistics (3PL) audits

  • Global suppliers, drug depots, couriers, and warehouse suppliers
  • WHO, EU, EC, ICH, FDA Good Distribution Practices
  • Suppliers with global drug depot and courier services

GCP audits

  • CROs and associated compounding and non-compounding pharmacies
  • 503A, 503B of the FD&C Act
  • Pharmacy binder reviews for clinical trials

Compliance audits

  • ISO 13485
  • ISO 14001
  • ISO 9001
  • ISO 14971
  • IEC 62366
  • 21CFR 210, 211, 11, 312, 820, 803, 812
  • ICH Q8, Q9, Q10
  • GCP, GLP, Canadian MDR, EMA Medical Device Directive (MDD), Japan, and Australia regulations

You deserve relief from the perennial struggle of audit completion.

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