CCMS Best Practices: Making The Most Of Limited Calibration Resources

FDA regulations are very clear in their expectations that calibrations occur on a regular and appropriate schedule, follow very specific and approved procedures, and be fully documented, with procedures in place for when problems arise. For example, procedures should be in place for when an instrument used in production is found to have been out of process tolerances or when a standard itself is found out of calibration.

Regulations do not go so far as to dictate what tools should be used to satisfy these requirements. They do not require, for example, that a computerized system be used. They do, however, require that whatever "system" is used be validated. While not dictating the use of computer technology, the FDA does realize the benefits of modern technology. They have introduced and continue to refine regulation to facilitate its use, including the 21 CFR Part 11 regulations on electronic signatures and the "Pharmaceutical cGMPs for the 21st Century."

Computerized systems, however, are valuable tools. Once the number of instruments being managed and the number of metrologists managing them reach a certain threshold, most companies concede that paper-based and even Microsoft Excel-based applications simply are not practical both because of usability and validation concerns. A software system designed for managing those events is required.

This paper explores the calibration management system features and functionality common to best-in-class calibration management applications designed for life sciences. These features are demanded and used by some of the world's most successful pharmaceutical, biotech and medical device companies and are intended to improve productivity and lower the costs and risks associated with compliance. Why are they so important to these companies? What are their benefits? How can you justify the time and energy required to learn to use these features and implement them?