San Diego, CA (PRWEB) October 01, 2013
AIS (American Internet Services), a Southwestern provider of tailored data center and cloud service solutions, today announced successful completion of an audit for Title 21 CFR Part 11 of the United States Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures (ERES). Attaining this important milestone helps FDA-regulated clients of AIS—including drug makers, medical device manufacturers, biotech companies, biologics developers, food manufacturers, and contract research organizations (CROs)—meet their own rigorous compliance requirements.
Conducted by Moss Adams LLP, one of the largest accounting and business consulting firms in the nation, the third-party audit of AIS data center operations demonstrates high standards in an area that is particularly sensitive for the Southwestern life sciences community.
“AIS continues to invest in the people, processes, infrastructure, training, and certifications needed to help clients pass their most stringent audit requirements regarding security, privacy, and integrity of sensitive information,” stated Greg Rollet, CEO of AIS. “Through action and oversight, we’ve demonstrated our commitment to this important industry segment so that companies facing FDA requirements can have confidence in working with AIS for fully compliant data center services.”
Francis Tam, Partner and National IT Practice Leader at Moss Adams, commented, “Completion of this Title 21 CFR Part 11 audit helps demonstrate the elevated importance which AIS places on being subject to independent scrutiny as it serves its federal customers.”
Title 21 of the Code of Federal Regulations (CFR) Part 11 defines the criteria under which electronic records and signatures are considered to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. Part 11 requires controls including audits, system v
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