Supports biotech, life science, and healthcare firms needing to comply with strict FDA guidelines for electronic records and signatures
SAN DIEGO, October 1, 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 validations, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule.
About AIS (American Internet Services)
AIS provides tailored data center and cloud service solutions to companies that require the best in security, compliance, connectivity, and customer service. AIS manages all aspects of IT infrastructure so that customers can focus on their core business. The company’s exclusive AIS Customer Advocacy™ service professionals have designed, implemented, and supported tailored packages for cloud, colocation, network connectivity, disaster recovery, managed storage, and managed security for more than 500 enterprises worldwide. Founded in 1989 and backed by private equity firms Seaport Capital, Viridian Investments, and DuPont Capital Management, AIS operates SSAE 16-compliant, SOC 1-, 2-, and 3-audited, redundant facilities in San Diego, Los Angeles, and Phoenix. For more information, visit www.americanis.net or call us at 1-866-971-2656.
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Brian Wood, VP Marketing, AIS
(858) 576-4272 x110