Putting Together an FDA Compliant Calibration Program

If your small company has grown to the point of managing its own equipment assets, it is likely you will need to put together a calibration program to document and manage calibration activities as well as handle out of tolerance conditions.  If you are starting from scratch, this can be challenging as you tackle the following issues:

  • What needs to be part of my calibration program (as opposed to maintenance, for example)?
  • Who is responsible for the program?
  • What numbering system will we use?  Can I use maintenance or asset numbers?
  • Who is responsible for scheduling work for calibrations that are performed in house or by contractor?
  • What kind of validated CMMS system should I use, or should I use a logbook or spreadsheet?
  • What are the most important features in a calibration tracking system?
  • How do we determine and identify what equipment needs to be calibrated?
  • What is the right tolerance for our instruments?
  • How should I assign intervals?
  • When should QA be involved?
  • When should I assign numbers to equipment?
  • How do I manage my standards?
  • What are the requirements for electronic signatures and records?

If you are tasked with this opportunity, you may be interested to know that GxPReady! is offering a free presentation that can help you answer many of these questions and provide a guideline to help you ensure that the program you set up is compliant with GxP requirements AND is manageable so that you don’t spend too many resources without benefit.  Contact us for more information.