21 CFR Part 11 Compliance for Calibration and Asset Management in Bio-Med applications

If you are running a calibration, preventative maintenance, and asset management operation with paper based or Excel spreadsheets, it may be taking lot of your valuable time scheduling, tracking and recording data for calibration and preventative maintenance activities. There are many automated solutions available that can make your life much simple and easy. Following key requirements should be considered when looking for automated solutions.

The Following presentation provides the details about the requirements and solutions.

  • Equipment design and selection shall be appropriate for the process requirements. (Defined through the process validation), Equipment shall be properly installed (confirmed through IQ), Functionality of Equipment shall match the process requirements (confirmed through OQ and PQ), The equipment shall be properly maintained (PMs, Repairs)
  • Establish and maintain schedules for PM/Inspections. The inspections, including the date and individual(s) conducting the inspections, shall be documented
  • Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented
  • The equipment shall be calibrated in regular intervals
  • Establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained.
  • Calibration procedures shall include specific directions and limits for accuracy and precision
  • When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. These activities shall be documented.
  • Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards
  • Calibration Records: The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented
  • g) Equipment. Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use.
  • (1) Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented.
  • (2) Inspection. Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall be documented.
  • (3) Adjustment. Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments.