FDA regulated industries, including life sciences and food processing, require total process awareness and control over production and incoming and outgoing supply chains. The entire chain of raw materials-to-process-to-finished goods-to-customer requires the combined attention of Enterprise Manufacturing Intelligence (EMI) and Traceability systems to maintain quality, safety and compliance.
The complimentary roles of EMI and traceability in regulated industry supply chains will be the topic of discussion during this webinar with David Miller, President of Mobia Solutions and one of the industry’s leading experts in technology, inventory management and traceability.
EMI and traceability systems augment each other and are essential to successful regulated production. During recalls both quality and genealogy systems are critical to characterizing the problem and untangling the mess.
What is at stake?
- In 2012 the FDA had 4,075 recall events (life sciences and food combined).
- In an Ernst & Young study, 77% of respondents estimated an average impact $30,000,000 per incident. 23% of respondents cited even higher costs.
- The cost of poor quality (COPQ) is estimated at 30% of gross pharmaceutical sales.
An integrated IT system is an important competitive strategy that governs product safety and quality messages to stakeholders, customers and regulators. This requires coordination of existing systems including ERP, WMS, MES, quality management, and traceability. The traceability and process performance measurements taken directly impact:
- Supplier management
- Logistics & warehousing
- Product recall management