GxP Validation: Compliance for an agile cloud
By Riju Khetarpal, Managing Director, Global Life Sciences at Box
Organizations in the life sciences industry, including pharmaceuticals, biotech and medical device companies, are rapidly transforming. Outsourcing is increasingly commonplace, and a continuous rise in M&A and joint ventures is fueled by a desire to rationalize portfolios and speed up innovation to bring therapies to market. While effective collaboration and speed to market remain critical for market leadership, a lack of effective risk management of intellectual property and proper information governance on regulated systems can lead to regulatory fines, legal exposure and revenue loss.
Due to this complexity, life sciences organizations haven't been able to move their content to the cloud as aggressively as they'd like. Many maintain legacy on-premises ECM systems in order to meet stringent guidelines issued by the FDA and other regulatory bodies on how information is stored, managed and distributed when it pertains to drug development, medical device development, clinical trials and patients. These systems, inflexible to user needs and time-consuming to maintain and validate, have created inefficient silos between regulated and unregulated information, and have slowed down collaboration and innovation.
Manage regulated and unregulated content with Cloud Content Management
At Box, our mission is to help organizations transform the way they work, even in the face of all this complexity. We now have Box GxP Validation, an innovative approach for maintaining GxP compliance in the cloud, which enables organizations to leverage a single secure, compliant Cloud Content Management platform to manage both unregulated and regulated content. Life sciences companies can now create, collaborate, manage, distribute and archive regulated content associated with clinical development and manufacturing processes.
Box GxP Validation provides customers with a Validation Accelerator Pack (VAP) and daily testing to qualify and maintain compliance of their Box instance. The innovative validation methodology from Box accelerates initial validation and lowers risk with the use of daily automated tests to assure a continued state of compliance for the Box platform. With access to regulated and unregulated content in a single repository that's highly secure, compliant and accessible anywhere, customers can find the information they need, whenever they need it, in a cost effective manner.
As part of Box GxP Validation, Box is partnering with USDM, a leading firm for risk management, technological innovation and business process for life sciences, to provide Cloud Assurance, a service that validates changes in the production environment of Box. USDM can also work with customers to ensure their own configurations and customizations are unaffected by these changes.
One cloud platform for a wide range of use cases
Box GxP Validation creates new opportunities for customers to create, manage, collaborate on 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. We're excited to enable new life sciences use cases with Box, including:
- Exchange of clinical content between sponsors, CROs, CMOs and investigator sites
- Collaboration and exchange of regulated content during joint development or M&A activities
- Secure archival of SOPs and clinical study documentation
- Compliance with 21 CFR Part 11 requirements by integrating Box with eSignature providers
- Use of Box as a compliant content layer with life sciences ISV and SI partners
Today, 800+ life sciences organizations are using Box, including Eli Lilly, Boston Scientific, GlaxoSmithKlein, AstraZeneca, Edwards Life Sciences, Daiichi-Sankyo and Shionogi. Box enables them to manage day-to-day operations, research, sales, marketing and global product launches in a secure and compliant way. With Box GxP Validation, these organizations and many others will be able to transform the way they work with both their regulated and unregulated content.
To read more about the validation process and qualifications for a GxP application, download our white paper.