FDA COMPLIANCE SOLUTIONS FROM QRS SINCE 1994
Analyze and investigate Quality System data from sources such as:
Institute Corrective and Preventative Actions:
- Internal Audits
- External Audits
- Service records
- Returned product
- Nonconforming product
- Management Review.
Verify and/or validate changes to assure:
- Improve processes
- Improve procedures
- Improve designs.
Educate and train personnel on changes to:
- Changes are effective
- Changes do not adverseley affect finished devices
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