Encore Systems Solutions for
Food & Pharmaceutical (FDA)
GENESIS32™ makes it easy to create applications that comply with the latest FDA regulations. Audit trails, enforced logins and restricted security access are integrated into every GENESIS32™ software system.
Industries Served
Benefits
For systems requiring FDA oversight, the following industries are benefiting from ICONICS' solutions:
Drug and Pharmaceutical
Food and Beverage
Medical Device
Customers who are deploying GENESIS32™ in an FDA 21 CFR 11 application will enjoy these benefits:
Maximum security with integrated popular biometrics
Operational accountability through sequence checking
Accurate audit trail information of who did it what, when, where, and why
Applications that are designed for the FDA 21 CFR Part 11 regulation
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Designed for FDA 21 CFR 11 Compliance and Accountability
The Food and Drug Administration has recently started enforcing the rules of compliance as outlined in the FDA 21 CFR 11 (Code of Federal Regulations: Food and Drug Administration Title 21, Chapter I, Part 11) - "Electronic Records; Electronic Signatures." GENESIS32™ offers many features that will help you build a system that complies with FDA 21 CFR 11. It enables proper handling and recording of FDA-regulated electronic information and applies "electronic signatures" such that the FDA considers them to be "equivalent" to that of handwritten signatures and documents.
Secure Audit Trails Track Operator Input and Control Changes
Using the GenEvent™ Server, a standard part of GENESIS32™, keeping track of operator input changes is automatic. This tracking system records the date and time stamp along with the name of the person performing the action, as well as the value entered and the tag name being affected. In addition, GENESIS32™ also captures the node name, thus recording information pertaining to who, what, when and where.
One Software System Reduces Development Time
Create applications with one common development studio and deploy them to popular Microsoft® Windows® operating systems such as Windows® 98, ME, 2000, 2000 Server, XP and Windows NT®. Deploy applications to Web browsers such as Microsoft® Internet Explorer and Terminal Servers as well as dedicated wireless Pocket PCs, Windows® CE, Embedded NT and Embedded XP devices.
Record and Report Operator Comments
Create applications with one common development studio and deploy them to popular Microsoft® Windows® operating systems such as Windows 98, ME, 2000, 2000 Server, XP and Windows® NT. Deploy applications to Web browsers such as Microsoft Internet Explorer and Terminal Servers as well as dedicated wireless Pocket PCs, Windows® CE, Embedded NT and Embedded XP devices.
Record and Report Operator Comments
Both the AlarmWorX™32 Logger and the TrendWorX™32 Logger record their information to industry standard databases, including Microsoft® SQL Server, MSDE, Microsoft Access and Oracle®. Using such standard corporate databases provides long-term maintenance, reporting and retrieval throughout the retention period.
Create Operational Sequence Checking for Operators
For applications that require operational system checks to enforce permitted sequencing of steps and events, GraphWorX™32 (the visualization component of GENESIS32) is ready to help.
Configuration and Runtime Password Revision, Control and More
The GENESIS32™ suite of applications offers many standard features. From password revision controls to timeout enforcement, from document revision control to unauthorized access detection and prevention, ICONICS' products are ready to assist in the overall management and accountability of today’s pharmaceutical industry related to meeting FDA 21 CFR 11 regulations.
Integrated Security Enforces Logins and Restricts Access with Biometrics
The GENESIS32™ suite offers a powerful Security Server component designed to restrict user access rights to various parts of the system. Not only are certain files and/or applications restricted, but specific features within each module may also be restricted on a per-user basis. Central to the FDA 21 CFR 11 is the absolute confirmation of users' unique IDs and the association of these with each employee’s actions. GENESIS32™ seamlessly integrates Biometric mice, hand, face and eye recognition as well as other Biometric technologies, providing the most comprehensive identification system available.
International Language Switching Technology
Companies needing to deploy their reports and documents anywhere in the world can now define multiple languages with automatic engineering units conversion.
Traceable Alarm and Event History
Record operator set-point and control changes using the GenEvent™ Server component. The GenEvent Server also creates a traceable history of other "system events." Include important items such as startup/shutdown sequences and times, operator login events, security issues, trouble reports, and much more.
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