Product category:
Process Control and Monitoring
News Release from: Eurotherm | Subject: 21CFR Part 11
Edited by the Processingtalk Editorial
Team on 21 January 2003
Product enhancements to suit FDA
validated systems
Eurotherm Limited has announced a major raft of product enhancements designed to satisfy the requirement of 21CFR Part 11 for US FDA Validation of pharmaceutical and food manufacturing processes
By ensuring that a number of key control and data acquisition products meet the demanding data storage and security requirements of the FDA 21CFR Part 11 (Electronic Records and Electronic Signatures) ruling, Eurotherm say that its customers will find it much easier to match regulatory requirements of their processes around the world 21 CFR Part 11 is a set of guidelines passed in 1997 by the FDA (the USA based Food and Drug Administration)
This article was originally published on Processingtalk on 22 Apr 2003 at 8.00am (UK)
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It requires companies providing drugs used by humans in the US to follow certain procedures regarding the tracking, tracing and authentication of records relating to the development and manufacture of those drugs.
The FDA requires continual record archiving during the life history of the drug production, which can be inspected at any time.
To assist customers in the pharmaceutical, food and related industries meet this type of regulatory requirement, Eurotherm has now added functionality to a number of products to match the requirements of 21CFR part 11.
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These new features are designed to provide a tamper proof log of process values and every change (including alarms, events and operator actions with associated user approvals) that happened during the drug production life cycle.
This functionality includes secure electronic signatures, tamper-proof data storage and audit trail traceability back to the batch.
The ability to connect all the Eurotherm range of products via secure networks allows these features to be applied to the lower cost and less configurable products.
Three key product families have been given added functionality to aid compliance to 21CFR Part 11.
These families are: the EurothermSuite Operations Viewer/Server; the Visual Supervisor (T800) Multi-Function Controller; and the 5000 Series data acquisition and management products.
A new software package, called 'Security Manager', simplifies the ability to manage and control all access security issues network-wide by providing a central environment to set-up user accounts and carry out regular account functionality, such as password changes.
The EurothermSuite Operations Viewer/Server is a PC based system designed to provide overall management and control of the complete process.
It includes the Invensys Wonderware world leading software InTouch and is designed to meet the diverse needs of operations, maintenance and plant management.
The simple to use display structure provides data to users in a fast and meaningful way.
Standard features include Client/server architecture with master/backup servers, defined display structure, trending, sophisticated alarm functionality, single global database, and time synchronisation.
21CFR Part 11 related security issues in this product are now handled by the Security Manager utility, which removes any dependency on and limitation of third-party software packages.
It provides updates to user accounts, logins etc, and the ability to distribute the security set-up to all nodes.
The Visual Supervisor (T800) is a powerful multifunction controller with data logging and integrated display.
It provides all the features required to control and monitor processes, functioning as either a stand-alone unit or as a building block within a larger system.
Standard features include batch management to ISA-S88 with batch log, recipe and set-point programmer, accurate continuous and sequential control, support for Modbus and Profibus, barcode reader and printer support, as well as time synchronisation.
The Visual Supervisor Auditor feature supports Electronic Records and Electronic Signatures.
Additionally on multiple Visual Supervisor node systems, the central control of all security functionality can be achieved with the Security Manager utility.
The Series 5000 Data Acquisition Product family (also known as graphic recorders) are designed to acquire process data and then to display, transfer and manage that data using secure means.
The Series offers multi batch recording, networking via Ethernet, remote viewing via Bridge software, time synchronisation, and report generation via an Excel add-in option.
21CFR Part 11 compliance is provided in this case by the built-in Auditor feature, covering electronic signatures and authorisation, secure, embedded, time-stamped audit trails and other security related features.
The ability to integrate any 2000 Series product with any of the above allows 21CFR Part11 functionality to be used plant wide.
The 2000 series consists of over 15 different PID controllers and indicators and standard features include: One to many PID loops; maths functions; logic functions; automatic PID tuning; support for Profibus, Modbus and DeviceNet.
For use in 21CFR Part 11 compliant applications, a lockout front panel key feature is provided.
Vince Lendrum, the recently appointed Eurotherm International Sales and Marketing Director, believes that the new additions to product functionality are a key requirement to increase the Eurotherm market share of global pharmaceutical and food business.
He comments: "A growing proportion of our international control systems business now comes from major drug manufacturers around the world, and the vast majority of these have to run FDA validated processes.
By providing them with carefully tailored product functionality designed to help them achieve that validation as painlessly as possible, we hope to develop many more working partnerships at all technical levels.
Our own offerings, added to those of other closely related specialists within Invensys Product Management Division, will form a powerful portfolio of solutions for customers wishing to meet FDA requirements".
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