Can you quickly and easily generate reports to satisfy your most demanding internal and regulatory partners? Can you create lot traceability and lot genealogy reports for audits?
ProFicient is a robust solution that can stand up to an FDA or internal audit while easily meeting the challenging requirements of 21 CFR Part 11. ProFicient boasts built-in checklist features needed to comply with Hazard Analysis and Critical Control Points (HACCP) and Sanitation Standard Operating Procedures (SSOP).
For a detailed look into ProFicient’s compliance features, visit the features page.
SPC software should benefit an organization through cost reductions and quality improvements, but our customers’ successes tell the story best.
Kraft Foods
Kraft’s global quality program is built around five core principles: Statistical Process Control (SPC), net content control, Hazard Analysis and Critical Control Points (HACCP), defect management, and audits. Kraft selected ProFicient because it was the most effective solution available to help them accomplish their goals in these key areas.
Alarms are essential to HACCP. With ProFicient’s alarming features, Kraft has the ability to apply an immediate response if a critical control point does not meet their standards or if there was a failure to gather data. With their previous system, reactions to critical events would not occur until the end of the shift. Test results were taken to the quality lab for analysis where the response was managed. With ProFicient, alarms instantaneously notify the right people so that action can be taken immediately. By managing alarm notifications alone, Kraft plants have realized significant cost savings.
The Pepsi Bottling Company
The Pepsi Bottling Company uses ProFicient as a centralized lab management system for statistical analysis and control of their global manufacturing operations. The system enables all manufacturing sites to ensure they are in compliance with Pepsi's strict quality standards for all phases of product manufacturing.
InfinityQS' Data Management System (DMS) allows automated data collection from Pepsi lab equipment worldwide. This direct communication with Pepsi's data gathering equipment creates an efficient, integrated system for managing and controlling their manufacturing processes.
“Proficient is an easy-to-use, flexible and centralized system that provides us with real-time access to performance information at all of our plants around the world. This allows us to instantly compare information, identify best practices, and quickly replicate our success on a global scale.”
-Tanya Peacock, The Pepsi Bottling Company.
Medtronic
At Medtronic Surgical Technologies, several thousand different part numbers are checked for quality compliance using a variety of different electronic gages. ProFicient helps Medtronic easily manage these part records and comply with thousands of related specification limits. Additionally, traceability and security features built into ProFicient make it simple to adhere to the FDA’s 21 CFR Part 11 regulations regarding Electronic Signatures.
Lastly, to help Medtronic with software validation, InfinityQS provided test cases, validation scripts and services so that Medtronic could perform a full functional verification of their ProFicient installation.
