Aware of the many choices in products and services, the consumer is conscious
of product price to value and demanding increased product quality,
safety, variety, and convenience. Most industries with batch manufacturing
processes are consolidating, requiring fewer plants to produce an
increased variety of products.
To survive, businesses that employ batch control processes must maximize
return on their assets while satisfying constantly changing consumer demands.
New government regulations continue to increase business costs.
Business and manufacturing process automation and integration have become
critical to business success.
While the functionality and standardization of commercial
off-the-shelf batch control systems has
increased dramatically in the last few years, they still
lack functionality needed to meet current and future
business requirements in the fine chemical, pharmaceutical,
food, and beverage industries. Standards
have been rapidly evolving and suppliers continue to
increase functionality needed to meet user business
requirements. Manufacturers in these industries can now develop an
automation strategy to meet current and future business needs using standard
products based on standards and not limited by technology.
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Batch Manufacturers Require More Robust, Dock-to-Dock Control Systems
1. By John Blanchard
ARC STRATEGIES
MAY 2003
Batch Manufacturers Require More
Robust, Dock-to-Dock Control Systems
Executive Overview ......................................................................3
The Batch Manufacturing Landscape ...............................................4
Standards & Regulatory Compliance Are Key to Success in
Batch Manufacturing.....................................................................7
Key Batch Control Standards and Guidelines....................................7
US FDA Ruling 21 CFR Part 11 .......................................................9
Product Genealogy Requirements ................................................. 11
Change Control Requirements...................................................... 13
Enterprise Optimization for Batch Manufacturers ............................ 14
User Survey: Batch Control System Requirements......................... 16
User Prioritized Functional Requirements ............................................ 17
Recommendations...................................................................... 21
THOUGHT LEADERS FOR MANUFACTURING & SUPPLY CHAIN
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