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Quality

Quality Management Systems Consulting (QMS)

A solid Quality Management System is essential in maintaining a “state of control” in a regulated environment. The CQV approach to quality system implementation includes:

  • Assessment of existing regulatory compliance capabilities
  • Development of suitable policies and procedures
  • Staff training and indoctrination
  • Ongoing monitoring and continuous improvement

CQV auditors have the experience and qualifications to assess the tools, techniques and controls in place for development and implementation of computer and IT systems within the GxP environment. We can provide supplier audit services on a global basis. CQV Lead Auditors and Technical Specialists have extensive experience in technologies such as:

  • Building and factory automation systems
  • Shop floor and smart manufacturing equipment
  • Laboratory systems and LIMS
  • IT for business solutions
  • Customer solutions and IT services
  • Systems Engineering

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Mock FDA Audits

Are you ready for an un-announced FDA inspection? To be protected from exposure to action by the FDA, CQV can help your organization achieve & maintain a state of “audit readiness” at all times!

  • Proof of Standards/Documentation
  • Responding to FDA Questioning
  • Employee Expectations
  • Staff Training/Indoctrination
  • Assessment of tools, techniques, controls
  • Supplier/Vendor/Process Integrity/Audits
  • React to Challenges

CQV participates in the American Society of Quality (ASQ). Most of our SME’s have completed Auditor and Software Quality Engineering certificates

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Risk-Based Approaches

Establishing a robust, risk-based approach to quality and regulatory compliance is one of the keys to success in today’s regulated industry. In order to stay on the cutting edge of current methodologies, CQV staff are consistently engaged in a wide-variety of industry committees, task groups, and conferences with special emphasis on risk-based approaches. We maintain memberships in respected groups such as PDA, ISPE/GAMP, IVT and ASQ; these professional communities are collectively setting the standards for today’s risk-based quality management. Guided by our depth of experience we actively contribute to the evolution of current guidance and regulatory interpretation on topics related to 21 CFR Part 11, Corrective And Preventative Action (CAPA), and Risk-Based Approaches to quality and regulatory compliance. CQV staff have also published several papers.

In addition to our professional affiliations, we also maintain relationships with premier compliance consulting companies representing hundreds of consultants worldwide:

  • CVO – CyberConseil: Lyon & Paris, France; Belgium, UK
  • Integrity Solutions: UK (EU)
  • Conform-IT: UK (EU)
  • Selby Hope International: UK (EU)
  • Yamatake Knowledgeware: Japan (Asia / Pacific Rim)

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