FDA COMPLIANCE SOLUTIONS FROM QRS SINCE 1994

Analyze and investigate Quality System data from sources such as:
  • Internal Audits
  • External Audits
  • Complaints
  • Service records
  • Returned product
  • Nonconforming product
  • Management Review.
Institute Corrective and Preventative Actions:
  • Improve processes
  • Improve procedures
  • Improve designs.
Verify and/or validate changes to assure:
  • Changes are effective
  • Changes do not adverseley affect finished devices
Educate and train personnel on changes to:
  • Processes
  • Procedures

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