Case Study: Food & Beverage
Food and pharma manufacturing standards are stricter than those in any other industry, affecting every aspect of research, sampling, production and distribution. The effect of food and pharmaceutical quality on human or animal health makes these products among the most heavily regulated in today’s market.
Calibration also helps you avoid potential recalls or litigation caused due to “bad” batches, reprocessing due to inaccuracies, safety hazards from physical, biological and chemical risks, etc. Quality and compliance problems can involve heavy costs in more than one way, so it’s essential to stay on track with your validation program and compliance-related testing.
Along with validation and qualification activities, food and pharmaceutical CGMP guidelines maintain that instrument calibration needs to be performed on a frequent schedule. This helps to reduce the risk of error, ensuring highly accurate, traceable and repeatable measurements throughout the production process.
The client is a manufacturing facility in Asia for a major US brand. The client wanted a cloud-based system that was:
Easy to configure and use,
Affordable to deploy and maintain,
Automated calibration test calculations and reporting,
Manages maintenance tasks and checklists,
Able to connect with their Fluke 754 document process calibrators.
ProCal Direct helped achieve the first important aspect of quality monitoring and assurance, which affect everything from a regulatory inspection for FDA compliance to International Organization for Standardization certification. Commitment to high quality standards also helps with building consumer trust and brand reputation. ProCal Direct provided the client with comprehensive control features support the compliant record management dictated for cGxP operations per 21 CFR Part 11, ISO 9000-2001, QS 9000, ISO 17025, ANSI 254 and others. The client was able to configure record access, yet restricted to authorized users as well as easily view Audit Trail records to confirm record integrity, with password verification and forced entry of a modification reason configured.
The client was also able to calibrate instruments also offer the highest degree of accuracy, minimizing errors so they fall within acceptable limits. Since they’re traceable to national or international standards, calibration reports help with both internal and external audits.
In addition, the analytic reports helped the client perform more efficient preventive maintenance via optimal testing scheduling, making it easier to ensure that equipment performs at optimum levels, reducing breakdowns and extending its lifespan. This further helped the client improves efficiency, uptime and cost savings as well, in terms of repairs, energy consumption, production losses due to frequent downtime, etc.
The management of the technical installation is simplified by going from multiple management systems to a single Maintenance and Calibration Management system, ProCal Direct.