Technology Solutions for the Life Sciences Industry
NexAge specializes in providing Technology Solutions in a range of business areas covering clinical, regulatory, content management, safety, quality, supply chain, data analytics and business intelligence. We have adopted global standards across all services covering ISO, GAMP5, GxP and 21-CFR Part 11 compliance needs. These alignments ensure that the product or services offered are in line with the statutory requirements. We offer solutions that are most suited for the customers’ business context and growth by utilizing a combination of our own Product / Service portfolio and from the clients Business Partners. This approach has yielded good results in meeting client business objectives.
Systems Validation Solutions
Validation is a key process in the life cycle of a computerized system. The validation process is mandated for regulated systems. Life Sciences organizations spend a lot of effort in making sure the system performs consistently to produce specifications and quality goals. NexAge has significant experience working with GxP guidelines. We understand the regulatory context and are driven by the desire to implement pragmatic approaches that meet compliance requirements. Our processes comply with all categories of GAMP Guidelines and we are able to perform qualifications at the Design, Installation, Operational and Performance levels.
NexAge Advantage: Validation services has multiple advantages including deep domain expertise in regulated industry, vast experience with 21 CFR Part 11 requirements with our professionals having successfully performed multiple DQ/IQ/OQ/PQ assignments with clients, and finally we have a flexible and cost effective delivery model enabling rapid deployment.
Supply Chain Solutions
The Life Sciences industry is experiencing challenges due to patent expiry, high cost and long lead time to bring out new drugs, pricing regulations, global competition, regulatory norms, and stringent quality protocols. Life Sciences supply chain solutions are complex and are required to be designed not only to ensure patient safety and regulatory compliance, but also to provide the firms with sustainable competitive advantage. An appropriate supply chain solution is necessary for a Life Sciences organization to execute in a compliant and profitable manner. Planning for raw materials sourced from global suppliers, dealing with manufacturing constraints across facilities, managing availability by establishing and monitoring distribution inventory levels, and tracking and responding to demand changes, are some of the challenges that Life Sciences companies face. It is necessary to implement adequate controls to ensure compliance across the supply chain solution.
NexAge Advantage: In the supply chain domain, NexAge specializes in delivering products, solutions and services for effective enterprise mobility & material tracking. NexAge has implemented mobility frameworks to a variety of industrial and personal mobile smart devices using Windows, Android & iOS platforms. Our solutions facilitates additional system controls real time during operations along with reduced information latency and improved data accuracy.
Big Data Analytics and Data Migration
Many Life Sciences organizations face the challenges of a multitude of legacy tools that operate in silos and prevent efficient use of critical data technology and with no clear measurement of business value and ROI. Often times varying engagement models provide inadequate cost and operational efficiencies and business needs and IT not aligned
NexAge Advantage: We offer Data warehousing, Data Migration, and Master Data Management services that help enterprises collect data from their ERP and other Business applications and from external and non-conventional sources to build strong enterprise-wide Data Analytics / BI capabilities for the organization.
NexAge uses collaborative processes for collecting, understanding, and sharing the information that can improve the organization’s business performance. Our implementation targets vital business priorities, selection of the right technology tools to suit existing IT and information resources and architecting a solution that addresses specific industry concerns and performance goals. Central to our solution is the simple idea of reuse; documented knowledge can be re-used, industry practices can be referred. Faster realization of business value could be obtained through reusable: libraries such as KPIs, data models, common data collection and processing routines.
Implementing BI and Analytics solutions is a complex and time consuming process and often no single solution will meet all requirements. However, we use documented knowledge and used Packaged Analytics solutions to provide a quick answer to the challenge of embedding knowledge and industry best practices into organizational processes.