Product category:
Plantwide control
News Release from: Rockwell Automation Global Manufacturing Solutions | Subject: Software for 21CFR11
Edited by the Engineeringtalk Editorial
Team on 14 July 2003
Full software solution to 21CFR11
An integrated range of manufacturing execution system and Scada software reduces the cost and complexity of compliance with US Food and Drug Administration 21CFR11.
Rockwell Automation is now able to offer pharmaceutical companies an integrated range of manufacturing execution system (MES) and Scada software that reduces the cost and complexity of compliance with the US Food and Drug Administration's Title 21 - Code of Federal Regulations - Part 11 (21CFR11) Drug manufacturers must comply with 21CFR11's requirements on traceability and record keeping if they are to sell their products in the US, and it is estimated that compliance can cost each company between $100 million and $250 million
This article was originally published on Engineeringtalk on 2 Apr 2002 at 8.00am (UK)
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The latest versions of Rockwell Software's key products enable manufacturers to comply with 21CFR11 easily and cost effectively, as well as integrate their production systems seamlessly with management level ERP systems.
The FDA requires drug companies to maintain detailed records of the manufacturing process for each batch of product, including recipe data and audit trails of changes made to processes.
21CFR11 allows electronic records and signatures as an alternative to a costly and time-consuming paper trail, and many manufacturers are investing in modern control systems that automatically capture all compliance data in electronic batch records.
Rockwell Automation has long experience of developing FDA validated control systems, and its products are used by most major pharmaceutical manufacturers in the world as well as biotech companies and makers of baby care and feminine care products.
The three essential elements in a 21CFR11 compliant system are: security of data; an audit trail showing who has accessed production files and the changes made; the ability to report the information required to demonstrate compliance.
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Key Rockwell Software products - including RSView Supervisory Edition and Machine Edition Scada packages, RSBatch batch management software, RSLogix PLC editing tools and RSNetWorx network configuration software - offer all these functions as standard.
Data security and an audit trail are ensured by integrating access to the manufacturing software with the standard Windows username and password login to identify users and their rights to access and amend files.
Their activities are automatically logged by the powerful transaction manager RSSql to the relevant batch records in any ODBC-compliant database such as Microsoft SQL Server or Oracle.
Data recorded includes username, old value, new value, comments and approver.
Reports based on the data logged to the database are then generated with the data-mining tool RSBizware Historian.
RSView Supervisory Edition (SE), Rockwell Software's latest multi-user Scada platform, has a number of additional features to enable 21CFR11 compliance.
Its distributed and highly secure architecture is ideal for the multi-server/multi-client control applications often found in pharmaceutical manufacturing.
Users can log in and out of the RSView SE client stations without affecting the software components of the RSView SE servers - even if server components are run on the same computer as a client station - preventing unauthorised access to the master files.
For the ultimate in centralised security management, access control, auditing and reporting, there is Rockwell Software's powerful change management software RSMACC.
RSMACC is a client-server system 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.
Designed to integrate with other Rockwell Software and Allen-Bradley products, a key module is RSMACC Audit.
This automatically gathers data from networked Allen-Bradley devices equipped with FactoryTalk, a consistent format for sharing manufacturing data across the enterprise.
With FactoryTalk, RSMACC is able to log information on changes made to electronic files such as PLC code to the same central database as other compliance data, enabling comprehensive reports to be generated from a single source.
Rounding off the complete compliance package is the Propack Data range of specialist enterprise product management (EPM) software for pharmaceutical and life sciences manufacturers, designed specifically to achieve 21CFR11 compliance.
Rockwell Automation acquired Propack last year, and its software covering the complete process from research and development to clinical trials and manufacturing integrate seamlessly with Rockwell Software's control and Scada products.
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