Server simplifies FDA compliance

The FactorySuite Industrial Application Server and InTouch 8.0 human-machine-interface software provide significant enhancements to companies challenged with meeting FDA 21 CFR Part 11 regulations.

The new FactorySuite Industrial Application Server and InTouch 8.0 human-machine-interface (HMI) software provide significant new software enhancements to companies challenged with meeting FDA 21 CFR Part 11 regulations.

These products represent a major milestone in Invensys' strategy to lower the maintenance and development costs involved in engineering FDA 21 CFR Part 11 applications.

The FactorySuite Industrial Application Server provides an infrastructure for simplifying the development, deployment, maintenance and administration of distributed automation applications.

It offers real-time data acquisition, alarm and event management, data manipulation services and collaborative engineering capabilities, which have been designed from the ground up for use in industrial automation applications.

When developing the Industrial Application Server and InTouch 8.0 software, Wonderware consulted with the FDA-compliance experts at Invensys Validation Technologies, an Invensys Pharmaceutical Solutions group that specialises in computer systems validation and regulatory compliance in FDA-regulated industries.

Through the combination of Invensys Validation Technologies' FDA-compliance expertise and Wonderware's extensive background in the industrial control software field, Wonderware has developed features and functionality that make it easier for customers to build systems that comply with FDA 21 CFR Part 11 and other regulatory requirements.

"Wonderware asked Invensys Validation Technologies to consult on how well its Industrial Application Server and InTouch 8.0 software work for applications that must be compliant for FDA 21 CFR Part 11 regulations, and we were very satisfied by our findings", said Richard Fecteau, General Manager of the Invensys Pharmaceutical Solutions group.

"Clearly, in designing this generation of products, Wonderware gave high priority to facilitating regulatory compliance".

With the InTouch 8.0 HMI, users now have enhanced security configuration capabilities specifically designed with FDA 21 CFR Part 11 in mind.

New security script functions provide easy configuration of access levels, audit trails and integrated operating system (OS) security.

Users can configure audit trails, which are tightly coupled with the application's OS security model.

In addition, the release of the Industrial Application Server offers unparalleled robustness for industrial applications because it provides data-model security at the lowest possible level of granularity.

It extends Microsoft's Windows security model down to the hardware layer, providing even greater security capabilities that specifically match factory requirements.

At this level, data is arranged according to area and the plant models.

Users also benefit from the Microsoft model's simple, centralised login procedures.

The Industrial Application Server expands upon these procedures after the clients reside in the system by carrying the security model down to the equipment and process-loop level, providing much greater granularity of secured access.

This level of security is needed because, while plants typically have a lot of highly skilled engineers and technicians who may be capable of making changes in applications, those applications must be secured at a low enough level that only authorised persons can make adjustments at authorised times.

The skill and authority levels are matched against the user's role for any specific piece of equipment or process loop, not just with individual permissions.

To further assist companies to lower the cost of engineering of FDA 21 CFR Part 11 applications, Wonderware has also released a new deployment and best-practices guide for FDA-regulated engineering applications, using the InTouch 8.0 HMI and the Industrial SQL Server 8.0 historian.

An Industrial Application Server FDA-regulation guide is also available from the FDA Resource Centre on the Wonderware website.

Wonderware's FDA 21 CFR Part 11 solutions complement other Invensys regulated industry offerings.

For example, Eurotherm offers two electronic data recorders with electronic signature and audit trail features, which allow users to securely gather and store data in tamper-proof electronic format.

For users of Foxboro's I/A Series automation system, Invensys offers a comprehensive program of automated tools and expert services that allows users to upgrade their existing I/A Series systems, eliminating the need to purchase, engineer, install and validate an entirely new system to comply with FDA 21 CFR Part 11 regulations.

Prism, Baan Process Solution's enterprise software for the IBM iSeries computing environment, can also assist with FDA compliance.

Back to top