An FDA-regulated company reports the ways in which GAGEpack gage tracking software has revolutionized its approach to more than 700 instrument records, formerly managed with an Excel spreadsheet using a “controlled” file.
Each month, 60 or more instruments must be updated from a calibration or maintenance event for the company. In the company’s previous approach, the process was fraught with errors from typos, transcription errors, and mistakes in the records passed on from month to month. The previous solution was to require the Calibration Master List of all of the instrument records, each one covering eight separate entries, to be checked by a second person and signed off monthly. In spite of these efforts, audit findings for Calibration Master Lists continued to include errors.
Finally, the company purchased GAGEpack, writing its own validation protocol and preparing a custom report that matched the format and content of the Calibration Master List.
A transition to the GAGEpack gage tracking solution meant reduction in error and duplication of effort. The database for GAGEpack is protected and backed up, and data can be checked only once per entry. Since the program is Part 11 compliant, conforming to federal regulation on software security and electronic signatures, it is acceptable to industry regulators. Since, as the company’s quality manager reports, it is a flexible database that is transparent to the user and customized to the company’s specific use, it is acceptable to managers as well. “And since it is easily grasped and common sense in the use, it has made it acceptable to technicians tasked with keeping the database up to date and current. That is a WIN-WIN-WIN situation.”