FDA Regulated

careersAs compliance standards become more stringent, FDA-regulated companies such as food, pharmaceutical and medical device manufacturers are implementing paperless quality systems for electronic records and traceability. By automating quality data collection, these companies can eliminate human error and comply with FDA regulations.

InfinityQS supports the technical requirements of a 21 CFR Part 11 compliant Statistical Process Control system. Our Part 11 features help protect companies governed by the FDA, but they also empower those who want to ensure the integrity of their data through good security practices. Download our FDA Part 11 White Paper to learn more.

Accellant
Nestle Waters
West Pharmaceutical
Quaker Oats
Kimberly-Clark
Tyson Foods
Sandoz Pharmaceuticals
Rich Products
Novartis Pharmaceutical
Alcon Labs
Ethicon-Endo Surgery (J & J)
Conagra Foods
McCain Foods:

McCain Foods Limited is a privately-owned Canadian multinational manufacturer of frozen and non-frozen food products with more than 55 plant operations on six continents and annual sales of more than $5.6 billion. McCain Foods is the world’s largest producer of French fries and potato specialties, and a manufacturer of pizza, appetizers and snack foods, vegetables, juices and beverages, entrees, oven meals, desserts and other quality products. McCain Foods USA Inc., the United States subsidiary of McCain Foods Limited, with the new acquisition has four major potato processing facilities and six other manufacturing operations in seven states.
Challenge
McCain Foods needed real-time, actionable quality data, particularly with alerts, to help comply with FDA Part 11 regulations. The food manufacturer needed to automate data collection and analysis and for the FDA's requirements for record-keeping. Increased security and electronnic signatures were a crticial need for compliance
Solution
McCain Foods standardized on InfinityQS software because it helped them create audit trails and incorporated electronic signatures. “InfinityQS SPC software has made tracking of quality information easier and serves as the central repository for all of our quality control,” said Guy Métivier, Manager of Manufacturing Execution Systems Global Technology Center, at McCain Foods. “On the statistical process control side, the software has enabled us to produce metrics and control the quality of our products based on the needs of our customers.” McCain foods implemented InfinityQS software worldwide.
Results
  • Real-time analysis saved significant process time
  • Strengthened compliance with the FDA's 21 CFR Part 11 Requirements
  • Acess to real-time, actionable data
  • Enhanced security