Genilogix Announces Availability of Validation Accelerator with e-Signature for Mercury TestDirector for Quality Center™
Solution to allow FDA regulated companies to use the latest automated testing tools from Mercury.
Las Vegas, Nevada (PRWEB) October 17, 2005 -- Responding to a growing demand for automated testing tools by Life Sciences companies, Genilogix LLC today announced the release of their Validation Accelerator with e-Signature for use with Mercury’s TestDirector for Quality Center product. This Validation Accelerator with e-Signature is the most recent addition to the Genilogix family of tools for use by FDA-regulated customers. These tools enable clients to leverage the power of Mercury’s best-of-breed, off-the-shelf software to optimize the computer validation process.
The Validation Accelerator with e-Signature provides the following components:
| | - e-Signature, to facilitate compliance with 21 CFR Part 11 requirements
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| | - General Validation Documents, to include Validation Master Plan, System Requirements Specification, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), Requirements Traceability Matrix, and SOP Checklist
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| | - Validation consulting services to prepare the validation documents and execute/document the test protocols
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The Genilogix e-Signature component enables clients to comply with 21 CFR Part 11 while aligning the functionality of TestDirector for Quality Center with the client’s internal validation procedures.
The e-Signature component is also available separately through Genilogix.
About Genilogix
Genilogix, LLC is an Information Technology company dedicated to delivering true value to customers in target markets. As one of Mercury’s select “Titanium” partners, Genilogix is also one of Mercury’s top re-sellers. Genilogix was recently honored as being the 14th fastest-growing company in the Philadelphia area by the Wharton School of Business. The Genilogix Life Sciences practice is focused on deploying Mercury tools to increase our customers’ ROI when performing Computer Systems Validation.
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