INFINITYQS INTERNATIONAL RELEASES SPC SUITE 2004
First Product of Its Kind to Integrate Advanced Real-time Statistical Quality Control with Lot Genealogy and Support for FDA's 21 CFR Part 11.
Fairfax, VA, (PRWEB) November 19, 2003 -
Wide quality control manufacturing solutions, today announced that it has unveiled the 2004 version of its flagship solutions suite, InfinityQS SPC 2004. The new software will provide manufacturers the ability to enforce stricter quality control measures, minimize human error and increase compliance with FDAÂ’s latest regulations.
Major new enhancements include:
· Lot Genealogy Tracking and Reporting: This merges complete lot traceability with advance statistical reporting. Lot Genealogy provides powerful traceability of all component and final finished good lot numbers and combines this information with complete lot summary statistical analysis. Reporting includes bottom-up reports for component lots and top-down reports for finished goods lots. For example, users may wish to determine what materials were used in the production of a particular finished goods lot (top-down) or investigate which finished lots were created from a particular lot of incoming material (bottom-up).
· 21 CFR Part 11 Enhancements: These include Change History and Reason for Change tracking and reporting, that support FDA’s 21 CFR Part 11 regulatory requirements. These features are based on sound principles of security and traceability that must be part of all compliant quality systems. The Change History and Reason for Change provide the Who, What, When, Where and Why to any change within the quality system database – an absolute requirement for regulated industries.
· Checkweigher Data Acquisition Driver: This driver collects real time test values from checkweigher equipment, performs extended calculations on those values and stores summary subgroup information into the InfinityQS database.
Mike Lyle, president of InfinityQS, stated: "We are very excited to release this best-in-class suite of solutions for today's demanding manufacturing environment. Our customer-centric solutions will allow users to do real-time statistical process control on their component lots and track them across a product’s cycle. The benefit of this information to an organization can be measured in the millions of dollars. Imagine having the product knowledge necessary to be able to limit a recall or to avoid a product recall all together. Then, combine this functionality with our support for 21 CFR Part 11 and you get a system that provides huge benefits to regulated and non-regulated industries alike.”
Prior to its release, InfinityQS SPC 2004 software was beta tested for over ten months with several Fortune 100 companies in the pharmaceutical and food areas.
“InfinityQS SPC 2004 is the real thing. We are very impressed with its functionality,” said a member of the SPC project team of a Fortune 100 health care manufacturing firm. “We have searched far and wide and found that this product is the only one that meets our 21 CFR Part 11 requirements.”
About InfinityQS International
InfinityQS International is the trusted provider of Statistical Process Control (SPC) software and technical services to national and international manufacturers such as Rockwell Automation, Caterpillar, Honeywell, Ethicon Endo-Surgery, Ball Corporation, Duracell, Boeing, Quaker Oats, Tyson Foods, Raytheon, Osram Sylvania, and other mission-critical manufacturers. With thousands of licensed users in demanding manufacturing environments, InfinityQSÂ’ real-time quality control software and value-added consulting services support both the business and technical objectives of corporate leadership, plant management and shop floor employees. InfinityQS can be reached at 1-800-772-7978 or by visiting http://www. infinityqs. com (http://www. infinityqs. com).
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