Why Choose Reliant FDA Experts?

Calibration and Maintenance Programs

To ensure a product or service is provided accurately and consistently, equipment must be qualified. To maintain the qualified status, equipment must be regularly calibrated and maintained in accordance with a pre-determined program and schedule. It is preferable for the calibration to be “traceable” to the internationally defined measurement units (such as NIST).

WHO SHOULD HAVE CALIBRATION & MAINTENANCE PROGRAMS?

Industry Code of Federal Regulation (CFR) References
Pharmaceutical 21 CFR 211.58, 21 CFR 211.67, 21 CFR 211.68, 21 CFR 211.160(b)(4)
Medical Device 21 CFR 820.70, 21 CFR 820.72
Dietary Supplement 21 CFR 111.25, 21 CFR 111.30(c)

COMMON ISSUES, MISTAKES AND PITFALLS

  • Not having clearly defined calibration intervals
  • Frequent unaddressed out of tolerance events
  • Use of contract calibration company without vendor qualification
  • Frequent missed calibration points

EXAMPLES OF THE HELP RELIANT CAN PROVIDE

  • Build a Sustainable Calibration and/or Maintenance Program
  • Audit, Assess, and Provide Recommendations on an Existing Calibration and/or Maintenance Program
  • Audit/Qualify Calibration Service Vendors
  • Perform a Calibration Status Gap Assessment

ASSOCIATED JOURNAL ARTICLES AND COMPLIANCE TIPS
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