Case Study: Food & Beverage
Client: Food & Beverage Global Corporation
This Fortune 500 company looked to ensure the company and its operations were in FDA compliance. Calibration records were not consistently kept; some were kept in digital files, such as Excel spreadsheets, while other records remained in paper format. When audited, this company could not deliver complete calibration results.
There were four primary goals of this organization, in addition to moving into full FDA regulatory compliance. One was to develop a better process to obtain and store data on instrumentation and instrument maintenance. Second, the company looked to develop a way for management to share calibration instructions and increase the accountability of the team. Third, there was a need to provide operators with data so they could move away from operating by “feel” (as an example, operators lacking accurate information would run too much steam to ensure a product was properly sterilized). And fourth, the company looked to eliminate inefficiencies caused by technicians frequently swapping instruments from one line to another to check readings and taking down two lines.
It was determined that Prime Technologies’ ProCal 21 CFR Part 11 compliant calibration management software would be the optimal solution. ProCal introduced a process and system to the team where they could consistently and accurately record results. ProCal brought immediate results that will continue to improve over time with additional optimization.
Once the transition to ProCal was complete, there were clear benefits to using the new calibration solution:
COST PER CALIBRATION
“For the first time ever, our team trusts the instrumentation and the controls that are used by our company. The productivity and efficiency that has come as a result cannot be overstated.”
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