ECM Solutions for Life Sciences


Introduction

The last ten years have seen a significant evolution of solutions to support compliance in the biopharmaceutical industry. Specifically, document and content management technologies have undergone a remarkable transformation that has taken them from vertical document management systems with departmental installations to cross-department solutions with publishing, electronic signatures and document workflow capabilities to knowledge management solutions that have improved both the capture and accessibility of knowledge assets.

Today, change continues in this space, as new compliance requirements combined with shifts in market focus and evolving technologies, such as business process management and application integration tools, are compelling organizations to re-evaluate their process, technology and compliance-related strategies. The outcome of such evaluations is shaping the next-generation of solutions for compliance and the means by which industry will respond and adapt to emerging compliance and market demands.

In this increasingly complex environment, effective management of regulated information is critical to reducing regulatory risk, improving submissions and increasing the speed of development and manufacturing cycles. To address these needs, TripodSoft provides a whole set of services to support the next generation of enterprise content management capabilities by uniting document and data management with compliance-centric business process management, application integration and collaboration tools.

Industry Challenges

Several factors are driving change in the way that biopharmaceutical organizations will need to approach the next generation of enterprise content management systems. One such factor is the need to adapt to a continually changing compliance landscape. Requirements for compliance have evolved significantly over the last ten years and the industry’s understanding of the impact of these requirements has grown respectively. As compliance requirements, such as 21 CFR Part 11, HIPAA, SOX and others continue to change, the technologies that support these requirements will also need to support rapid adoption of such changes will require increased visibility of documents and business processes.

Additionally, factors such as changing market dynamics and increased competition, as well as product evolution, such as the evolution towards targeted treatment solutions, will continue to impact the requirements for content management across the enterprise. Specifically, the capability to effectively collaborate, both within organizations and with external partners, suppliers and vendors, will become more and more important. Additionally, the ability to effectively manage and control the greater volume of information anticipated as a result of regulatory and product evolutions will become an ever more important area of focus. Finally, increased competition in the marketplace will mean that organizations must find new ways of increasing process efficiency and productivity, as well as new ways of harnessing the value of existing information assets. These and other challenges will drive the requirements for a new generation of enterprise content management system; a next generation that is driven by an underlying compliance-centric architecture and is able to rapidly adapt to changing business, product and compliance environments.

Key Features

  • Support for critical industry regulations and processes, such as GXP (GCP, GLP, GMP) and 21 CFR Part 11 compliance
  • Automated content lifecycle
  • Repository-neutral architecture
  • Extensive configuration capabilities
  • Open standards (e.g., J2EE, XML, Web Services Architecture)
  • Component-based approach to support interoperability and flexibility
  • Records management and archiving

Benefits

Our Next-Generation Solution aids organizations in enabling compliance, reducing costs and accelerating revenue by providing an architecture that addresses the functions required to support data and document management, business process management, application integration and collaboration components. Specifically, we deliver business benefits in four key areas:
  • Compliance and quality
  • Efficiency/cost reduction
  • Revenue acceleration
  • IT maintenance and validation