FDA 21 CFR Part 11 and S88 Solutions

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Automation Management Systems and Productivity Tools Proficy Change Management (formally Manager) Automation Management Systems (AMS) and Productivity Tools are designed to simplify and optimize the managing of applications and devices in plants and factories. A Proficy Change Management Automation Management System provides all of the tools necessary for tracking and coordinating changes. As a client/server system, it offers version control, audit trails, security, scheduling, and reporting capabilities that streamline your operations and help you meet regulatory requirements with ease. Proficy Change Management Productivity Tools, whether purchased as stand-alone products or as additions to a complete	Download the datasheet
Proficy Change Management AMS, complete specialized tasks. For example, the GE Compare tool lets you identify changes made to logic, data, and documentation in PLC programs.
FDA 21 CFR Part 11 and S88 Solutions On August 20, 1997, the Food and Drug Administration (FDA) developed a uniform approach to regulating electronic signature, record keeping and reporting practices for all business disciplines under its control. Dubbed FDA 21 CFR Part 11, this regulation has far-reaching implications for all businesses within the Bio-Pharmaceutical industry, as well as other regulated industries like Food and Beverage…particularly as more advanced technologies begin to find their way into plant-level systems. Despite the fact that FDA 21 CFR Part 11 has been on the books for over three years, recent enforcement trends indicate that the FDA is becoming much more active in the enforcement of this policy. In fact, recent months have brought several warning letters - even 483's (Inspectional Observations) - to companies who are not in compliance or who have not made formal plans and schedules to be compliant in the near future. In an effort to help businesses from across the FDA-regulated spectrum comply with FDA 21 CFR Part 11, Advantage offers solutions from manufacturers that have taken a leadership role in developing software-level solutions to meet the demands of this critical regulation. Working in unison with key biotech and pharmaceutical representatives, FDA regulatory personnel, original equipment manufacturers and systems integrators, the manufacturers are developing the tools that will empower all FDA-regulated companies to come into compliance with FDA 21 CFR Part 11. S88 The U.S. standard ISA S88.01 for Batch Control Systems has become one of the most widely adapted standards for manufacturing control systems. S88 defines a common set of models and terminology that can be used to define batch manufacturing systems. The standard has been effectively applied in flexible manufacturing facilities, where companies want to use the same production equipment to make many different products, even if the manufacturing processes could be run continuously. Advantage offers solutions from manufacturers that have taken a leadership role in developing software-level solutions to meet the S88 standards.
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