Software keeps track of compliance issues

Edited by the Engineeringtalk editorial team May 13, 2003

Manufacturers operating in tightly regulated industries can cut the complexity and cost of regulatory compliance with the Rockwell Software Maintenance Automation Control Centre.

Manufacturers operating in tightly regulated industries such as pharmaceuticals or food and beverage can cut the complexity and cost of regulatory compliance with the Rockwell Software Maintenance Automation Control Centre (RSMACC).

The most advanced change management product on the market, RSMACC provides a simple and cost effective means of recording the information required to comply with US Food and Drug Administration Title 21 - Code of Federal Regulations - Part 11 (21CFR11) and other quality assurance systems.

To comply with 21CFR11, drug manufacturers are required to log all changes to production processes and electronic files.

Other consumer product industries, including food and beverage, are also becoming more highly regulated, and even in sectors where regulatory compliance is not yet required, it is good manufacturing practice to monitor changes to process-critical systems to ensure full product traceability.

RSMACC is a powerful client-server software tool that enables manufacturers to detect and record alterations to electronic files, monitor critical computer services and log system events from one central location.

The RSMACC server holds PLC programming software and code in a central RSSql data repository, and only individuals with the appropriate authority can gain access to make amendments.

Users are authenticated by their Windows network username and password and given the appropriate rights to access, read or change electronic master files.

Designed to integrate closely with other Rockwell Software and Allen-Bradley products, RSMACC automatically collects and stores messages from networked Allen-Bradley products equipped with FactoryTalk Audit.

FactoryTalk offers a consistent format for sharing manufacturing data, allowing users to share critical plant floor information with the rest of the enterprise quickly and easily.

FactoryTalk Audit is a key module that enables RSMACC to compile records of changes to PLC programs for example in compliance with 21CFR Part 11 without operator intervention.

Because all current versions of software are held in one secure database rather than on floppy discs, engineers always know where to find the latest version of a program.

This avoids delays in solving production problems or restoring systems following a crash or other disaster and the latest version of programming software is always used when configuring hardware.

Once a day, RSMACC automatically uploads the files running in PLCs and other control devices and compares them with the master files stored in the central repository.

Reports on any differences between the two versions - including when the changes were made and by whom - can then be compiled and delivered in a variety of formats, including posting to a web page or email.

RSMACC offers a range of other important benefits for any manufacturer's maintenance, repair and operation (MRO) department.

The system helps to increase plant uptime and cut maintenance costs by centralising, managing and maintaining all the information needed for engineers to stay on top of maintenance requirements.

By integrating information from a variety of sources on the plant floor, RSMACC allows maintenance managers to access all relevant information from the server-based central repository via any RSMACC client workstation.

It gathers information directly from Rockwell Automation software packages such as RSLogix, RSNetWorx, Entek Emonitor Odyssey and even third-party applications to manage power and energy data, predict machinery failures and collect warnings, errors and other information for easy analysis.

For manufacturers in highly regulated industries, RSMACC offers a cost effective means of collating all the data required for regulatory compliance.

All manufacturers however will benefit from the product traceability and software version control offered by this all-encompassing change management software.