PharmComm TestScriptor, The World's First Automated Validation Solution, Transforms Computer Systems Validation For Life Sciences.Business Editors & Health/Medical Writers BIOWIRE2K WILMINGTON, N.C.--(BW HealthWire)--Oct. 30, 2000 PharmComm TestScriptor heralds a new era in validation and regulatory compliance Cetan Technologies, Inc. has introduced its revolutionary new automated validation solution, the PharmComm(TM) TestScriptor. With the automation-assisted PharmComm TestScriptor, Life Sciences companies can validate their computer systems faster, more cost-efficiently, and with less audit risk than ever before. Using PharmComm TestScriptor, pharmaceutical, biotechnology, and medical device businesses worldwide can reduce the effort of validation testing and still meet rigorous regulatory compliance requirements Compliance requirements are a series of directives established by United States Federal government agencies that summarize hundreds of Federal laws and regulations applicable to Federal assistance (also known as Federal aid or Federal funds). . Built on a breakthrough nonintrusive test methodology, PharmComm TestScriptor executes all testing on an independent hardware platform to eliminate any threat of corruption or inaccuracy in·ac·cu·ra·cy n. pl. in·ac·cu·ra·cies 1. The quality or condition of being inaccurate. 2. An instance of being inaccurate; an error. . This nonintrusive design, paired with built-in test scripting The instructions in a test program. It defines the actions and pass/fail criteria. For example, if the action is "to enter a valid account number," the expected result is that the data are accepted. Entering an invalid number should yield a particular error message. See test case. software, allows the creation of linear test scripts and test libraries that minimize the validation of the test tools while maximizing test automation. Cetan Technologies, a world-class computer systems validation provider formerly known as PharmComm, applied its extensive experience with Life Sciences system validations to create PharmComm TestScriptor. Over the past five years, while completing hundreds of validation projects, no adverse observations were obtained from regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. for the company's computer validation documents. "Life Sciences companies have previously been unable to use intrusive, automated software testing Software testing is the process used to measure the quality of developed computer software. Usually, quality is constrained to such topics as correctness, completeness, security, but can also include more technical requirements as described under the ISO standard ISO 9126, such as part of the computer system validation process. This is because intrusive test automation software resides inside the same system that's being tested," explained G. Raymond Miller, Cetan Technologies co-founder and chief technology officer. "The nonintrusive PharmComm TestScriptor eliminates this problem by leveraging an independent test platform that resides completely outside of the system under test, allowing automation-assisted validation for the first time," continued Dr. Miller. "This reduces costs, minimizes human error, improves time to market, and gives Life Sciences companies a competitive advantage in an increasingly tough pharmaceutical marketplace." PharmComm TestScriptor can aid in the validation of specialized Life Sciences systems as well as enterprise systems. Chromatography chromatography (krō'mətŏg`rəfē), resolution of a chemical mixture into its component compounds by passing it through a system that retards each compound to a varying degree; a system capable of accomplishing this is called a data systems, LIMS LIMS Laboratory Information Management System LIMS Library Information Management System LIMS Limb Infrared Monitor of the Stratosphere LIMS Land Information Management System (Canada) LIMS Logistics Information Management System (Laboratory information systems), plate reader systems, adverse event tracking systems, supply chain systems, and manufacturing control and inventory systems are some examples. Up to 80% of the validation process can be automated, assuring high quality reproducible test results in the shortest possible timeframe. PharmComm TestScriptor is designed to provide maximum flexibility and choice for today's fast-moving companies. Many Life Sciences companies choose to outsource the entire computer system validation process to Cetan Technologies. Others perform their own validations and may use standard libraries from Cetan Technologies or scripts custom-designed by Cetan Technologies. Still others may design their own validation scripts, using a simple drag-and-drop interface. To learn how Cetan Technologies can help Life Sciences businesses improve and streamline computer systems validations, call 1-866-99CETAN, or visit http://www.cetantechnologies.com . ABOUT CETAN TECHNOLOGIES Cetan Technologies is a pioneer and market leader in a new class of automated, nonintrusive testing (testing) nonintrusive testing - Testing that is transparent to the software under test, i.e., does not change its timing or processing characteristics. Nonintrusive testing usually involves additional hardware that collects timing or processing information and processes that and validation solutions, large scale testing lab services, consulting, 21 CFR CFR See: Cost and Freight Part 11 services, and outsourced testing services and training. New products and services include PharmComm(TM) TestScriptor, which automates key elements of computer systems validation; AutoValidator(TM), a complete platform-independent testing solution that resides outside the system under test to produce more pure test results; and Cetan Labs(TM), a remote testing lab that facilitates load and applications testing. TRADEMARKS AutoValidator, Cetan Technologies, the Cetan Technologies logo, Cetan Labs, and PharmComm are trademarks of Cetan Technologies, Inc. All other trademarks and registered trademarks are property of their respective owners. PRODUCT DEMO: Visit the Cetan Technologies booth, No. 1922, at the annual meeting of the American Association American Association refers to one of the following professional baseball leagues:
AAPS Association of American Physicians and Surgeons AAPS Ann Arbor Public Schools AAPS American Association of Plastic Surgeons AAPS African Association of Political Science ), Indiana Convention Center The Indiana Convention Center is a convention center located in Indianapolis, Indiana. It contains over 400,000 square feet (0 m) of open exhibit space and almost in Indianapolis, October 30 - November 2, 2000. |
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