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Quality Digest

FDA Compliance

Genilogix Releases Validation Accelerator with e-Signature

Published: Wednesday, October 26, 2005 - 22:00

Responding to a growing demand for automated testing tools by life-sciences companies, Genilogix LLC recently released its Validation Accelerator with e-Signature. The device is designed to work with Mercury’s TestDirector for Quality Center product, which enables clients to leverage optimal power in the computer-validation process. The Validation Accelerator with e-Signature provides the following components:
  • E-signature, to comply with FDA 21 CFR Part 11 requirements
  • General validation documents, including a validation master plan, system requirements specification, installation qualification, operational qualification, performance qualification, requirements traceability matrix and SOP checklist
  • Validation consulting services to prepare documents and execute/document the test protocols

The e-Signature component is also available separately though Genilogix. For more information, visit www.genilogix.com.

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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.