FDA, Good Manufacturing Practices GMP, quality system QSR, ISO 13485 regulatory consultants manufacturing development device, drug, diagnostic, combination medical products, 510(k), PMA, IDE

Quality Management /GMP Systems -
Compliant, Practical Approaches

Our industry and company knowledge base, client-interactive methodologies, and independent recommendations help you design practical quality assurance programs and quality management systems. The Tamarack Group helps develop compliant, robust, and innovative systems that reduce risks, solve problems, and support future growth, including systems for –

  • Document control
  • Record management
  • Requirements for electronic document and record management systems
  • Purchasing
  • Material management
  • Facility, equipment and utility monitoring and management
  • Environmental monitoring and control
  • Design control
  • Testing control
  • Supplier, vendor, contractor control
  • Personnel training
  • Production control
  • Product dispositioning
  • Discrepancy/deviation/non-conforming product management
  • Investigations
  • Corrective and preventive action
  • Change control
  • Internal audits

We combine creativity with a rigorous understanding of products and operations; clients profit from our knowledge and deliver on their vision using our insights.

See our books on Documentation Basics , Documentation Practices and Risk Management !!