FREMONT, Calif., June 13, 2013 /PRNewswire/ — ValGenesis Inc., the market leader in enterprise Validation Management Software solutions, today announced that it has attained Safe Harbor certification developed by the United States Department of Commerce and the European Commission reflecting its commitment to the privacy of the data hosted in its validated private Software as a Service (SaaS) platform.
Hosted ValGenesis Validation Lifecycle Management System (VLMS), through its validated private cloud, allows companies of any size to manage their Validation Lifecycle, Risk and Change management processes, as a 100% paperless process, with built-in best practices. The Safe Harbor certification allows ValGenesis Inc. to extend the hosted ValGenesis VLMS offerings to regulated Life Science companies based in the US or the European Union.
In 1998, the EU enacted a directive on data protection that would prohibit the transfer of personal data to non-EU nations (including the U.S.) that did not meet the EU standards for protection. U.S. companies can opt into the program, as long as they adhere to the seven principles outlined in the Directive. These principles must provide:
Notice – Individuals must be informed that their data is being collected and about how it will be used.
Choice – Individuals must have the ability to opt out of the collection and forward transfer of the data to third parties.
Onward Transfer – Transfers of data to third parties may only occur to other organizations that follow adequate data protection principles.
Security – Reasonable efforts must be made to prevent loss of collected information.
Data Integrity – Data must be relevant and reliable for the purpose it was collected.
Access – Individuals must be able to access information held about them, and correct, or delete, it if it is inaccurate.
Enforcement – There must be effective means of enforcing these rules.
The Safe Harbor certification facilitates business transactions without interruption when dealing with the EU. The aim of this certification program is to bridge the difference between the data protection practices of the EU with those of the U.S.
"At ValGenesis, Inc. we are committed to the safety and security of all personal data," says Siva Samy, Chief Product Strategist. "Therefore, we constantly implement and upgrade the latest security technologies to ensure the highest protection for all the private data, both while it is being stored and during times of data transfer."
To learn more about the Safe Harbor program, and to view the ValGenesis Inc's certification, please visit http://www.export.gov/safeharbor.
ValGenesis, Inc. is the provider of an innovative software platform designed to provide the foundation for compliance-based validation activities in Life Sciences companies. ValGenesis provides the first Enterprise application to manage the corporate validation lifecycle process. Through an industry peer review committee, the Parenteral Drug Association (PDA) recognized the ValGenesis solution with its very prestigious New Innovative Technology award. The ValGenesis Suite is designed to be fully compliant with FDA 21 CFR Part 11 requirements. For more information, visit the ValGenesis website at .
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