Quality System Audits

  • Overview
  • Benefits
  • Why Work With NSF?

Our team of experienced former regulators and industry professionals can perform a thorough, in-depth assessment of your quality management system (QMS) against the latest regulatory requirements and industry best practices. We will identify any weaknesses and areas for improvement, and recommend solutions to address deficiencies. Our detailed audit report can then serve as the basis for a site-wide corrective action plan to remediate deficiencies and create a more robust and sustainable QMS. We have extensive experience in conducting audits and we work with clients to remedy weaknesses in their QMS and create a compliant, practical and sustainable system.

The QMS is the foundation upon which everything else is built. We have a proven track record of assisting companies to establish and maintain best-in-class quality management systems.

For more information about FDA and Health Canada related services in quality systems and compliance, email uspharma@nsf.org or call +1 202.822.1850.

For information on services related to European and other international agencies, email pharmamail@nsf.org or call +44 1751 432 999.

Benefits

We specialize in performing quality systems audits. Our former regulatory agency staff is skilled in performing these audits and our seasoned industry professionals have many years’ experience designing, implementing and operating robust and compliant quality management systems. Because we audit many quality systems every year, we can advise you on current industry best practice. Our staff even helped to write ICH Q10 Pharmaceutical Quality System. No one is better placed to help you implement a compliant, workable and sustainable QMS to meet your business needs for years to come.

Why Work With NSF?

This case study provides a real-world example of how working with us can help your company.

Challenge: A highly diversified pharma company based outside Europe had grown by acquisition and as a consequence had developed a range of quality management systems (QMSs) and inherited a number of others. NSF was asked by top management to review the range and extent of GxP quality systems in place and make recommendations for a single company-wide QMS suitable for its modern business model and meeting all anticipated regulatory requirements.

Solution: NSF created a global QMS designed to manage and monitor an organization where all products were developed, manufactured, tested and distributed using external organizations under contract. The QMS also provided meaningful information to senior management to enable them to exercise their role of ownership and continual improvement of the QMS. It also helped by establishing a formal system of quality planning to support continual improvement, managed by the senior management team and administered and supported by corporate QA.

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