Easily manage all regulatory affairs content, data and workflows on one holistic, unified platform for a single source of truth. This platform accelerates innovation and reduces time to market for new therapies, devices and medicines.
Pulling together data to document processes for compliance is often difficult and time-consuming for life sciences organizations. Most have fragmented legacy systems, disparate technologies and some even use spreadsheets to manage key regulatory processes globally — impacting time to market for new products.
DXC Life Sciences Connected Platform serves as a hub to bring compliance components together and securely integrate and connect the flow of data across regulatory affairs ecosystems in a seamless manner.
This cloud-based, open digital platform simplifies the management of regulatory affairs content, data and workflows by integrating electronic document management (EDM) systems, publishing solutions such as electronic Common Technical Documents (eCTD), and regulatory information management (RIM) systems. The resulting business ecosystem reduces management and integration costs and simplifies the job of adding new applications and tools as needs change.
DXC Life Sciences Connected Platform in action
DXC Life Sciences Connected Platform provides a clear framework for the regulatory affairs life-cycle management: discovery, clinical, regulatory and safety.
The solution transforms, standardizes and streamlines content, data, workflows and end-to-end processes across the enterprise. You can easily digitize content and prove compliance. It supports extensible, common core services that track, store and control documents; connect people and processes; and drive data insights.
DXC Life Sciences Connected Platform features a modern, web-enabled interface, with a representational state transfer (REST)-based open architecture, which means you can use APIs to rapidly integrate best-of-breed applications from DXC Technology and other vendors and quickly adopt technologies such as artificial intelligence (AI) and smart automation.
Application modules from DXC that can be used to add specific functionality include: research and development (R&D), product and registration tracking, submission and publishing, quality and manufacturing (Q&M), viewing and archiving, and quality management system (QMS).
The solution can be deployed as dynamically scalable software as a service (SaaS), managed by DXC (multi- tenant with no customization, or multi- instance with customization). Or the platform can be delivered on-premises (customer-managed). This solution is mobile-ready upon deployment and supports a user base of less than 10 to more than 20,000.
The intuitive user interface is easy to navigate, can be personalized and delivers simple, ubiquitous access to all relevant regulatory affairs data. Collaborative tools are embedded to enhance teamwork; reporting is configurable; and visual layouts make it easy to review critical data in dashboards of your choice.
Life Sciences Connected Platform business value
Once deployed, DXC Life Sciences Connected Platform globalizes the management of key regulatory affairs processes, tasks and systems (such as EDM, eCTD and RIM) into a single, integrated platform that delivers:
Controlled data management. Digitize and take control of regulatory enterprise content, using best practice modules to:
- Simplify the job of meeting regulatory compliance needs by improving data quality, automating workflows and gaining visibility into content status
- Reduce business risk with standardized and streamlined business processes
- Control the distribution of data and content, centralizing planning, tracking and reporting
- Gain insights to increase performance and shorten time to market
Automation and productivity. Decrease overhead costs and improve compliance and data accuracy with advanced automation and AI capabilities, which make it possible to:
- Increase output and improve productivity and data quality, as well as reduce the time needed to complete tasks and lower overhead costs by the removing siloed systems
- Get meaningful information by integrating data from different systems and providing a real-time, holistic view of business performance
- Improve efficiencies, simplify business processes, streamline communications and reduce the chance of human error by using embedded collaborative tools
Simplified data access. Transform, standardize and streamline content, data, workflows and end-to-end processes across the enterprise, creating a single source of truth. Business leaders benefit from:
- A governance, risk management and compliance framework that ensures structured, consistent data access
- Better insights enabled by centralized data
Streamlined compliance across the regulatory ecosystem. Quickly pull together and overlay industry best practices to manage content and meet regulatory compliance requirements, enabling you to:
- Use a reliable rules engine for policy- driven control
- Lower operating costs and business risk
- Comply with the electronic records management requirement 21-CFR-Part 11 of FDA’s regulations for electronic records and electronic signatures (ERES)
Reduced cost of ownership. Start using this affordable, scalable solution with built-in security on a modern technology stack right out of the box. Our SaaS pricing and deployment models give you flexible options that scale with your business. DXC can help you:
- Maximize return on investment (ROI) with lower up-front investment costs and predictable as-a-service fees
- Reduce costs with multi-tenancy, or customize with our multi-instances option
Why DXC?
DXC Technology has served the life sciences industry for decades. DXC brings industry best practices distilled from our deep expertise and solutions together in a single, connected system to help you transform, standardize and enhance both compliance capabilities and operational efficiency.
DXC’s digital technologies give life sciences organizations the tools they need to accelerate innovation and reduce time to market for new therapies, devices and medicines. DXC’s proven expertise helps customers improve business agility and operational efficiency.