Alongside the launch of a new product, Box has brought to the fore yet another acronym some people are going to have to get to know: GxP.
GxP is a general abbreviation for "good practice" or “best practice” quality guidelines and regulations. The "x" is a placeholder for the various fields—the pharmaceutical, manufacturing, financial or food industries, for example. Using this logic, good agricultural practice would be termed “GAP.”
Along these lines, Box on Jan. 18 introduced Box GxP Validation, a new approach for maintaining GxP compliance in the cloud for a potential large group of businesses.
Box is starting its GxP Validation initiative with the pharmaceutical, biotechnology and medical device businesses to develop, validate and operate their GxP compliance standards within its platform. Box GxP Validation methodology complies with GAMP5 (good automated manufacturing process) guidelines, accelerates validation processes and lowers risk via use of daily tests to ensure a continued state of compliance for the Box cloud content management platform.
Partners with USDM Life Sciences for the GxP Package
The cloud storage and collaboration tools maker has partnered with Santa Barbara, Calif.-based USDM Life Sciences, a risk management, technological innovation and business process optimization firm for the life sciences and healthcare industries, to provide the software for the project.
Because content (digital images, documents, logs) is increasingly becoming an integral part of how life sciences organizations deliver the next generation of therapies to improve health and wellness, Box is enabling these businesses to manage both unregulated and regulated content in one centralized cloud content management platform.
“With GxP Validation, companies in regulated industries can eliminate inefficient silos between regulated and unregulated information and speed up collaboration and innovation,” Box Managing Director for Life Sciences Riju Khetarpal said.
Box GxP Validation enables users 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 and clinical study documentation;
- remain compliant with 21 CFR Part 11 requirements by integrating Box with an eSignature provider of choice, such as Adobe Sign and DocuSign; and
- use Box as a compliant content layer with life sciences ISV and SI partners.
As for the key software in the package, USDM Life Sciences is providing CloudAssurance, 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.
Since announcing Box for Life Sciences in August 2014, Box has seen continued growth in the life sciences industry, with customers that include Eli Lily, AstraZeneca, Jazz Pharmaceuticals and Boston Scientific.