ValGenesis, Inc. Achieves SSAE 16 SOC 2 Type 1 Audit Certification
Passing the rigorous SOC 2 exam solidifies ValGenesis Inc. as the trusted leader for providing hosted validation software solutions to Life Sciences companies
FREMONT, Calif., Aug. 22, 2013 /PRNewswire/ -- ValGenesis Inc., the market leader in enterprise Validation Management Software solutions, today announced that the company has successfully completed a Service Organization Control 2 (SOC 2) Type 1 certification under AT Section 101. Completion of the SOC 2 Type I certification indicates that processes, procedures and controls adopted by ValGenesis Inc. in their validated private cloud have been formally evaluated and tested by an independent accounting and auditing firm. The certification included the company's controls related to the Trust Services Principles and Criteria of Security and Availability.
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. Organizations with certification and compliance requirements such as FDA, EMA and HIPAA etc. may request and leverage the ValGenesis SOC 2 Type I report as part of their compliance strategy.
"SOC 2 exams are rigorous independent assessments, geared toward technology service providers, especially providers of hosting solutions to regulated manufacturing companies," said Siva Samy, Chief Product Strategist, ValGenesis, Inc. "With our successful completion of certification, we are able to provide our customers with greater insights into our controls, procedures and systems for our hosting solution."
This certification is also an important step for any Software-as-a-Service (SaaS) provider that supports outsourced, mission-critical, and information technology services. The audit includes a full assessment of:
- Security: Data centers are protected against unauthorized access (both physical and logical).
- Availability: Data centers are available for operation and use as committed or agreed.
A SOC 2 examination is widely recognized, because it represents that a service organization has been through an evaluation of their control activities as they relate to the applicable Trust Services Principles and Criteria.
ValGenesis, Inc. is the leading 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 http://www.valgenesis.com.
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