Life Science/ Pharmaceuticals
IBM® Maximo® Calibration provides a solution to help you manage your calibration assets and the standards that are used to calibrate them. IBM Maximo for Life Sciences uses Maximo Calibration features to support life sciences and pharmaceutical manufacturing business requirements.
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. Maximo solutions provide support for asset-related CAPA processes, and support in validation projects by providing Compliance Assistance Documentation.
You can use Maximo solutions to manage the calibration of instruments that measure process variables such as temperature, pressure, and flow. By usingMaximo Calibration or Maximo for Life Sciences, 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, Maximo Calibration records your calibration history 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.
Maximo Calibration and Maximo for Life Sciences also work with IBM Maximo Mobile applications. The Maximo Mobile Suite products work in a connected or disconnected mode with mobile devices, extending Maximo Calibration and Maximo for Life Sciences to remote workers. When you install a license for Maximo Calibration or Maximo for Life Sciences and a license for IBM Maximo Mobile Work Manager, you can access calibration functions from a mobile device. There are no additional installation requirements.
Maximo Calibration and Maximo for Life Sciences are designed specifically for recording and tracking calibration data. IBM Maximo Asset Managementapplications include fields, features, and actions that are specific to calibration.