Box, Inc, a provider of cloud content management, today announced Box GxP Validation, an innovative new approach for maintaining GxP compliance in the cloud. Box GxP Validation enables Pharmaceuticals, Biotechnology and Medical Device businesses to develop, validate and operate their GxP compliance standards within Box. Box GxP Validation methodology complies with GAMP5 guidelines, accelerates the validation process, and lowers risk via use of daily tests to assure a continued state of compliance for the Box cloud content management platform.
Box GxP Validation creates new opportunities for customers to build, manage, collaborate and distribute regulated content in Box as they work cross-functionally within their organization or with external business partners that are critical to the clinical development and drug manufacturing processes. Box GxP Validation provides businesses in the life sciences industry with a Validation Accelerator Pack (VAP) and daily reports to show that Box is functioning as intended to qualify and maintain compliance of their Box instance, so that they can:
– Exchange clinical content between sponsors, Clinical Research Organizations (CROs), contract manufacturing organizations, and investigator sites
– Collaborate and exchange regulated content during joint development or M&A activities
– Secure archival of Standard Operating Procedures (SOP) and clinical study documentation
– Remain compliant with 21 CFR Part 11 requirements by integrating Box with an eSignature provider of choice, like Adobe Sign and DocuSign
– Leverage Box as a compliant content layer with life sciences ISV and SI partners
As part of Box GxP Validation, Box is partnering with USDM, a leading risk management, technological innovation and business process optimization firm for the life sciences and healthcare industries, to provide Cloud Assurance, a new compliance maintenance methodology that continually tests all key functionality of the Box service prior to its release into production. Cloud Assurance validates change in the production environment to ensure that the change has not impacted the intended use of the service. USDM also works with clients directly to ensure their own configurations and customizations are unaffected by these changes on a case by case basis.