FREMONT, Calif., May 10, 2016 /PRNewswire/ — ValGenesis Inc., the market leader in enterprise Validation Lifecycle Management Software solutions, announced today that it has completed its Service Organization Controls 2 (SOC 2) examination under AT Section 101, Attest Engagements (AICPA, Professional Standards) for the period of January 1st 2015 through December 31st 2015 for the second consecutive year.
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The SOC 2 examination is performed in accordance with AT Section 101, Attest Engagements (AICPA, Professional Standards) with completion denoting that selected ValGenesis Inc. processes, procedures and controls have been formally evaluated and tested by an independent accounting and auditing firm. The examination included the company's controls related to the Trust Services Principles and Criteria of Security, Availability, Processing, Integrity and Confidentiality. Further, the SOC 2 is designated as an acceptable method for user entity management thereby obtaining assurance of service organization internal controls over Security, Availability, Processing Integrity and Confidentiality without conducting additional assessments.
As a widely recognized exam, the SOC 2 examination indicates that a service organization has been through an evaluation of their control activities as they relate to the applicable Trust Services Principles and Criteria. A Type II report not only includes the service organization's system description, but also includes detailed testing of the design and operating effectiveness of the service organization's controls.
Through its validated private cloud, hosted ValGenesis Validation Lifecycle Management System (VLMS), 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. Organizations with certification and compliance requirements such as FDA, EMA and HIPAA etc., may request and leverage the ValGenesis SOC 2 Type 2 audit report as part of their compliance strategy.
"With our successful completion of SOC 2 Type 2 audit for the second consecutive year, we are able to provide our customers with greater insights into our controls, procedures and systems involving our hosting solution" stated Siva Samy, Chief Product Strategist, ValGenesis, Inc. "Regulated life science companies continue to choose ValGenesis primarily because we embrace the changing regulatory and compliance landscape. Our ability to successfully pass this rigorous, in-depth audit confirms that ValGenesis has the proper controls and processes in place thus delivering the highest-quality validated hosting services to our clients."
"ValGenesis' leadership and IT teams demonstrate an exceptional commitment to transparency, proactively implementing controls and protocols for security, availability, processing, integrity and confidentiality through the audit of ValGenesis VLMS," stated Scott Price, Managing Partner at A-lign. "It has been our pleasure to work with a company determined to follow the approved processes and procedures, a company that has truly achieved best practices with their cloud solution."
About ValGenesis
ValGenesis, Inc. is the creator of an innovative software platform serving as the foundation for managing compliance-based validation activities in Life Sciences companies. ValGenesis, Inc. provides the first enterprise application to manage the corporate validation lifecycle process. As the only system for managing validation execution and approval 100% electronically, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award. The solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. For more information, visit www.valgenesis.com.
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