April 11, 2023

Ensuring FDA Compliance in Your Calibration and Maintenance Program: Best Practices


Calibration and maintenance are critical activities for ensuring that equipment is operating correctly and safely in your facility. However, these tasks are also subject to strict regulations from the Food and Drug Administration (FDA). Here are some best practices for ensuring FDA compliance in your calibration and maintenance program:

  • Understand the regulations: Familiarize yourself with the FDA’s regulations and guidelines for calibration and maintenance. This includes understanding the requirements for documentation, record-keeping, and reporting.
  • Develop a compliance plan: Develop a comprehensive compliance plan that addresses all aspects of your calibration and maintenance program. This should include procedures for ensuring compliance with regulations, as well as a plan for addressing any non-compliance issues that may arise.
  • Use a computerized maintenance management system (CMMS): A CMMS can help to automate and streamline many of the tasks associated with calibration and maintenance, including documentation, record-keeping, and reporting. Make sure the CMMS you choose is compliant and validated to FDA 21 CFR Part 11 and 820.
  • Follow standard procedures: Establish standard procedures for calibration and maintenance that are compliant with FDA regulations, including the FDA’s CFR 21 Part 11 requirements. This will help to ensure that tasks are performed consistently and correctly.
  • Train your team: Proper training of your team is crucial to the success of your calibration and maintenance program. This includes training on equipment usage, safety, and maintenance procedures, as well as training on FDA regulations and compliance.
  • Conduct regular audits: Regularly audit your calibration and maintenance program to ensure compliance with FDA regulations. This includes conducting regular internal audits, as well as preparing for any external audits that may be required by the FDA.

By following these best practices, you can ensure FDA compliance in your calibration and maintenance program and avoid the risk of penalties or penalties. Remember to stay up-to-date with regulations, have a compliance plan, use the right tools, follow standard procedures, train your team and conduct regular audits.

For more information on FDA compliance, email us at software.sales@simco.com, or schedule a CMMS demo here.




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