FARMINGDALE, NY (04-14-07): EtQ has announced the release of the EtQ eValidator, an automated validation tool that runs Process Qualification (PQ) scripts in a matter of minutes.
For companies regulated by the Food and Drug Administration (FDA), systems validation is a necessary requirement to ensure a secure environment. The process of validation an enterprise system involves running test scripts at the installation level, the process level and the operational level (called IQ, PQ, and OQ, respectively). These scripts are often long and time consuming, and can take months, if not a whole year to compile and run.
Recognizing this incredible task of validation, EtQ has released the eValidator utility, which is designed to automate the PQ process. The eValidator is a comprehensive set of commands that, when executed, will run the test scripts automatically, and generate a full report of the results of this script.
"In a typical validation scenario, the process of running PQ scripts can take a long amount of time," says Mohammad Nobani, President of EtQ,Inc. "Using EtQ's eValidator, a typical workflow that would normally take 3 hours to complete can now be run, assessed and approved in 3 minutes."
The ramifications of the eValidator are staggering. Streamlining the validation process can have a tremendous effect on both a company's implementation time and personnel resources. Using eValidator to automate the validation process will cut a company's validation time by as much as 400% - a 4 day validation project can be done in less than a day using EtQ's eValidator. Furthermore, the eValidator can be run by a single employee, and can eliminate the extensive resources needed to dedicate to a typical validation project. Finally, eValidator is able to compile a comprehensive report library of all tests and scripts run on the system. When audited by the FDA or other governing body, the validation reports are immediately available for review.
EtQ has plans to further extend the eValidator concept, in building validation test scripts into EtQ's planned configuration management application, allowing new workflows and applications to immediately generate and run a validation test script. This concept will not only allow the management of configuration made to the system, but also enable validation of these new configurations almost immediately.
EtQ is the leading Enterprise Quality and Compliance Management Software for identifying, mitigating, and preventing high-risk events through integration, automation, and collaboration. EtQ uses best-in-class, integrated modules and enterprise application integration to manage and measure quality and compliance processes and execute organizational change. Key modules within the product include: Document Control, CAPA (Corrective and Preventive Action), Audit Software, Complaint Handling, Risk Management, Change Management, Employee Training, Project Management, Nonconforming Materials, Enterprise Reporting, and more than 20 additional compliance-oriented modules. With its world-class flexible workflow, collaborative platform, EtQ has developed a unique niche to support enterprises involved in various compliance management initiatives such as; cGxP (FDA), ISO 13485, ISO 9001:2008, ISO/TS 16949, ISO 14001, ISO 22000, AS 9001, TL 9000, OHSAS 18001, RoHS, Sarbanes-Oxley, HACCP, SQF and similar standards for compliance and regulatory management. EtQ has been providing compliance solutions to a variety of markets for over 15 years.
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