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eRPortal Software Now Title 21 CFR Part 11 Certified and in Compliance with USA FDA Regulations and Guidelines for Electronic Records and Electronic Signatures (ERES)

Arbour Group, provider of global regulatory solutions, provided certification of compliance


West Springfield, Mass. (August 10, 2016) – eRPortal Software, Inc., a provider of software as a service (SaaS) and on-premise software products for managing strategic assets and operations, announces Title 21 CFR Part 11 validation and certification of compliance of its suite of products with US FDA Regulations and Guidelines for electronic records and electronic signatures (ERES).

Arbour Group, providers of global regulatory solutions, certified compliance with 21 CFR Parts 11, 21 CFR 211 current good manufacturing practice for finished pharmaceuticals, 21 CFR 820 current good manufacturing practice for medical devices, and 21 CFR 11 electronic records and electronic signatures.

Part 11, as commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. It applies to FDA regulated industries including, biotechnology companies, biologics developers, contract research organization (CROs), drug makers, and medical device manufacturers, and requires implementation and maintenance of controls (audits, audit trails, documentation, electronic signatures, systems validations, etc.) for software and systems involved in processing electronic data. Part 11 also applies to submissions made to the FDA in electronic format but exclude paper submissions by electronic methods.

“Our customers must adhere to more stringent and complex compliance mandates and it remains our focus to ensure our solutions are certified to ensure proper alignment with associated requirements. Compliance with Title 21 CRF Part 11 is a great example of this,” said Edward Garibian, president of eRPortal Software. “Part 11 compliance speaks not only to the architecture and development of best practices related to the software’s use at the GMP facility, but how that software is deployed and integrated into its intended application.”


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About eRPortal Software, Inc.

Founded in 2004, eRPortal Software, Inc. provides high performance, web-enabled, enterprise asset management, maintenance management, and materials tracking software solutions for managing strategic assets and operations. The company’s technology maximizes operations efficiencies and asset utilization level. The company serves customers in industrial and manufacturing, and higher education markets, as well as utilities and municipalities. They include Badger Meter, Caterpillar, Flowserve Corp, Sunny Delight Beverages, Johns Hopkins University, NC State University, Princeton University, and the cities of Columbus, Indiana, Lubbock Texas, and Olathe, Kansas.

eRPortal is a privately held corporation headquartered in West Springfield, Mass. More information about the company and its products is available at www.erportalsoftware.com/products/.