Paperless Calibration Compliance for National and International Standards and Regulations
 

  1. Requirements
    1. 21 CFR Parts 58, 110, 211, 606, and 820
    2. 21 CFR Part 11
    3. ISO 9001
    4. ISO 13485
  2. A Quality Calibration Program
    1. Writing, formatting, updating, improving, and using calibration procedures
    2. Calibration records, labels, intervals, and certificates
    3. Traceability to the SI, TUR ≥ 4:1
    4. Equipment “end of life” requirements
    5. Out of tolerance procedures
  3. Managing a quality calibration program
  4. Paperless records using Adobe Acrobat Pro

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