Managing calibration assets and standards

You can manage your calibration assets and the standards that are used to calibrate them.

You can ensure regulatory compliance with FDA (21 CFR part 11 for support of electronic signatures and electronic audits), calibration of instruments, tools and measurement equipment and standards. Compliance Assistance Documentation provides support for asset-related CAPA processes, and support in validation projects.

You can manage the calibration of instruments that measure process variables such as temperature, pressure, and flow. You can maintain a historical record of calibration measurements for instruments and measurement and test equipment. You can also track historical records of the calibration instrument or the standard that is used to calibrate an instrument or measurement and test equipment.

You can create data sheet templates to document your instrument specification and apply the templates to multiple instruments. You can select or define tolerance levels and input-range limits for each data sheet and associate the data sheet with job plans and work orders. You can then use the data sheets in work orders to gather calibration As Found and As Left data to record and analyze the performance of the instrument.

By creating performance maintenance intervals, you can automatically create calibration work orders to ensure that the calibration of assets is completed on time. Calibration job plans define the procedures that you use to calibrate an instrument. You can use revision control to update the information of a job plan or a data sheet and maintain records of the previous revisions.

To comply with industry regulations, your calibration history is recorded to ensure that your calibration assets are fully traceable. You can identify which standard or measurement and test equipment was used to calibrate an asset. You can apply reverse traceability to identify all assets that were calibrated with a specific standard.