niaid’s integrated solution delivers functional, technical ... · microsoft sharepoint (formerly...

SUCCESS STORY

E N T E R P R I S E I N F O R M A T I O N M A N A G E M E N T

Industry

Government

Customer

National Institute of Allergy and Infectious Diseases (NIAID)

Challenges

n Communicate and collaborate across numerous different locations

n Centralize safe and efficient storage of information with real-time access

n Adherence to government regulatory requirements

solutIon

n OpenText Document Management n OpenText Records Management n OpenText Archive Server n OpenText Application Governance &

Archiving for Microsoft® SharePoint®

BenefIts

n Improved collaboration that overcomes geographical barriers

n Increased productivity and efficiency with real-time access to information

n Cost savings through integration with existing technology

NIAID had been experiencing exponential growth of electronic documents that needed to be shared among thousands of staff and contractors worldwide. The agency had been using Microsoft® SharePoint® to facilitate basic content management and collaboration, but needed to find additional Enterprise Content Management (ECM) capabilities, including sophisticated work-flow and advanced document and records management functions to meet the Institute’s growing needs.

To address these requirements, NIAID created a unique, integrated ECM strategy to establish synergy between its existing infrastructure and the OpenText suite. This integration enabled NIAID to leverage the advantages of SharePoint’s ease of use while enhancing the Institute’s storage, management, and collaboration capabili-ties. NIAID benefited from important effi-ciency and accuracy improvements as the Institute can now effectively store and share information among its 3,600 onsite staff and contractors across several divisions

nIaId’s Integrated solution delivers functional, technical, Compliance, and Cost requirementsThe unique integration of OpenText Application Governance & Archiving for Microsoft® SharePoint® with existing technology enhances collaboration across NIAID’s widespread workforce

and many locations. This approach also ensured the Institute’s ability to comply with a complex array of government and industry regulations.

NIAID is part of the National Institutes of Health (NIH), which is an agency within the U.S. Department of Health and Human Services and the primary federal agency for conducting and supporting biomedi-cal research. NIH’s key objectives are to prevent diseases and to investigate causes, treatments, and cures for common and rare diseases. It is made up of 27 institutes and centers, including the National Cancer Institute, the National Library of Medicine, and NIAID.

NIAID was established 50 years ago and is the second largest NIH institute in terms of funding, a close second to the National Cancer Institute. NIAID focuses its research on infectious diseases like HIV/AIDS, flu, tuberculosis, and malaria, as well as tropical diseases and a number of other emerging and re-emerging infec-tious diseases. For example, research

Remote access and geographically dispersed business models have become the norm in today’s global business economy, making the efficient storage, management, and

collaboration of documents not only essential, but a critical success factor. This was the case with the National Institute of Allergy and Infectious Diseases (NIAID).

NatioNal iNstitute of alleRgy aNd iNfectious diseases (Niaid)

SUCCESS STORY


supported by NIAID contributed to the development of nearly 30 antiretroviral drugs that have helped transform HIV from a fatal infection into a manageable chronic condition. Eighty percent of NIAID’s budget is extramural and is used to fund research throughout the world. The other 20 percent is mainly intramural, including clinical research activities at the NIH hospi-tal on campus and global clinical trials in Africa in Mali, Uganda, and Nigeria, and in China, South Korea, and India.

Background In 2007, NIAID’s document and records management, storage, and collaboration issues came to a head when the Institute realized that most of its business processes were paper based and that it was experiencing exponential growth of electronic documents.

The challenges of managing these processes and growth were exacerbated by NIAID’s reliance on shared network disk drives for document management. It was difficult for users to identify current versions of documents; there were no processes to remind users when updates were required or had been made, backup times were growing, and safeguards to prevent the accidental deletion or overwriting of files were limited. With no version control, documents were mushrooming, and numerous dupli-cate documents were taking up valuable storage space. In addition, no enterprise search capability existed, making it impos-sible to search across shared drives in a meaningful way.

Although SharePoint was used for limited unstructured collaborations, NIAID didn’t have robust workflow and metadata

tools for document-sharing communities. NIAID’s geographically dispersed opera-tional structure compounded the burdens because many paper documents had to be routed to numerous locations for review and ink signatures. The reliance on paper and physical routings made it increasingly difficult for NIAID to comply with a complex array of industry and government regula-tions such as the Federal Drug Administra-tion Act, Freedom of Information Act, and Department of Defense (DoD) records management standards.

defining specific requirements to make the best choice NIAID set out to find a comprehensive ECM solution that met its functional, technical, compliance, and cost requirements. An overriding criterion was that the ECM solu-tion be able to meet the Institute’s wide range of requirements, while seamlessly integrating with other existing applications used at NIAID. As opportunities presented themselves in the future, the selected ECM system would also have to have customization capabilities, as well as a qualified pool of technical expertise, at the ready.

The organization recognized that its new solution would become the cornerstone for enabling the rapid delivery of small and medium-sized projects using standard functionality, while at the same time, keeping the door open for NIAID software engineers to create more complex and custom solutions based on the ECM package. This way, the selected ECM solution would help address the immediate issues with the existing system but would also become a solid foundation for future

To date, NIAID has undertaken 25 projects of a complex nature— too complex to previously have been possible without the enhanced document management, storage, and collaboration provided by the OpenText ECM solution.

growth. To ensure that the selected ECM solution would meet all requirements, the selection effort became an organization-wide process. NIAID established a panel of scientific and business experts who defined a set of specific functional, technical, and compliance criteria that became the basis for the ECM solution selection process.

The selection team determined that ECM from OpenText provided NIAID with one integrated solution that included advanced capabilities for document management, records management, and sophisticat-ed yet user-friendly workflow, as well as forms-driven data management — with limited initial customization but customization capabilities available as required by the user.

The OpenText ECM solution also met all of NIAID’s next-level criteria, such as provid-ing sophisticated, multi-tiered storage to help with better information lifecycle management so that the organization could manage long-term data retention requirements with the confidence that its legacy data was accurately saved and securely stored.

focused team approach enhances accuracy and speed To integrate OpenText and NIAID’s other applications, NIAID established a core ECM program management group to undertake the technical architecture and implementa-tion. In keeping with its integration strategy of mainly configuring rather than customizing, the team was mostly comprised of product specialists supported by a limited number of engineers. Within the program, individual project teams liaised with business units across the organization as needed.


SUCCESS STORY


The selection team determined that ECM from OpenText provided NIAID with one integrated solution that included advanced capabilities for document management,records management, and sophisticated yet user-friendly workflow, as well as forms-driven data management — with limited initial customization but customization capabilities available as required by the user.

Each project team works on multiple projects and is comprised of dedicated product specialists and developers. The teams are highly focused and agile so they can rapidly deploy new solutions and value to the business community while maintaining a high-level of quality. Each project engage-ment also includes training and change management as required components.

The first projects were limited to a single business unit with a small number of users—a strategy NIAID quickly adopted as a best practice. NIAID recommends this approach of initially selecting projects that can start small and then grow horizontally and vertically because it allows the organization to gradually become more comfortable with the technology before pursuing larger, more complex organization-wide opportunities.

Today, NIAID attributes a large part of their ongoing success of the ECM solution to a commitment to the team approach that includes a full-time program manager in charge of the solution and a dedicated technical team focused 100 percent on the OpenText program. Team members are either building ECM solutions or adding ECM capabilities to the transactional systems. This team model also includes adherence to rigorous quality assurance and change request processes that are developed for transactional applications.

Defining key enterprise level parameters at the onset, where possible, was also an important lesson learned. NIAID defined the overall enterprise architecture, commu-nity information, security model, taxonomy, metadata, roles, and responsibilities as early on as possible. This provided a road map that could be adapted as needed along the ECM implementation journey.

Integration creates synergy to leverage the benefits of the old with the new Throughout the ECM solution implementation, the OpenText ECM solution delivered on its promise of integration ease and effective-ness. For instance, in terms of coordinating with the existing NIAID practices, the solution handles authorizations based on the Institute’s creation of a number of groups and then assigns rights to the groups. In NIAID’s efforts to retain the SharePoint environment, the Institute used out-of-the-box OpenText web parts available in Application Governance & Archiving for Microsoft SharePoint (formerly Content Lifecycle Management (CLM) Services for SharePoint). The web parts allow docu-ments stored in the OpenText document management repository to be downloaded and viewed from within SharePoint. In

addition, OpenText workflows were inte-grated with a database that stores all of the Institute’s staff and roles, enabling NIAID to use just one organizational structure for all of its workflows.

To date, NIAID has undertaken 25 projects of a complex nature— too complex to previously have been possible without the enhanced document management, storage, and collaboration provided by the OpenText ECM solution.

malaria Vaccine development Branch (mVdB) NIAID’s first project for the Malaria Vaccine Development Branch (MVDB) was particularly challenging. MVDB was commissioned in 2001 to research, develop, and produce prototype malaria vaccines and to conduct early phase clinical trials of promising vaccine candidates. By the time this project began in 2007, MVDB had accumulated 6 years worth of data supporting 8 investiga-tional new drug applications and 12 master protocols. This equated to more than 17,000 data files, more than 1,000 animal and laboratory protocols, 128 associated Standard Operating Procedures (SOPs), and at least 50 different users accessing the data on a daily basis. MVDB’s use of network shared drives and a combination of Microsoft Office documents, including Word and Excel, to manually manage its business process and associated data caused inefficiencies and put the organi-zation at risk for data loss. The metadata for all of the files was maintained in a single shared Excel document.

To address issues like manual tracking of protocol data that was cumbersome and error-prone and misplaced documents due to shared drives that provided limited access controls, NIAID used OpenText to develop a system to eliminate manual document numbering and allow for distrib-uted metadata management.

In addition to cleaning up the 17,000 documents, re-organizing them, using the metadata, and migrating all data into the new environment (including the migration of 128 SOPs), the NIAID team designed the primary interface to include a custom dashboard that integrates search, work-flow, initiation, and tracking. The dash-board included highly structured views


SUCCESS STORY

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of the information with filtering capabilities, extensive search functions, and the ability to launch workflows straight from the dashboard. The solution also included the ability to clone entire protocols, includ-ing protocol structure, sub-protocols, and SOPs. As part of the cloning process, the application directly manipulates document content to reflect the new protocol by updating signature blocks, headers, footers, and numbering. Document content is also automatically updated as a protocol or SOP moves through its lifecycle.

Users can bypass the dashboards and go directly to the native OpenText ECM interface to view and edit documents. The documents are consistently organized and end users can also upload data files and reports directly into a data reports folder during protocol execution. Users also have the ability to view and edit documents from email links so that document approval and rejection does not have to be done solely from within the MVDB application.

Through this challenging project, NIAID met its business objectives of providing secure and convenient access to this collection of important documents and, although Federal Drug Act (FDA) requirements are not yet formally necessary, the system can be scaled to support future FDA 21 CFR Part 11 compliance. The team also automated management of staff’s SOP certification and association of SOPs and protocol.

research Information management system portal The ECM system is also a major component of the Research Information Management System (RIMS) portal, which was devel-oped as part of a much larger solution for managing multi-year grant and research contract awards. NIAID awards about $2 billion annually through this system. As the Institute’s project team designed and built the system, the core platform was flexible enough to be able to accommodate new and refined requirements.

Deployment of the system resulted in significant improvements regarding timelines… the Institute was able to reduce the number of late awards to approximately 50 percent.

(06/2013)01054.7EN

For each award, NIAID needs to simul-taneously manage the workflow of 19 documents across eight groups with approximately 300 end users and 10 NIAID departments. Before RIMS, the Institute used a combination of email and shared drives with no workflow, making it very difficult, if not impossible, to check the status of the overall award process. This project involved several customizations including providing external users access to the OpenText repository through the SharePoint portal via web parts available in Application Governance & Archiving for Microsoft SharePoint.

Deployment of the system resulted in significant improvements regarding time-lines, as well as greatly reducing the effort involved in managing complex document management processes and reducing the number of emails. Most importantly, the Institute was able to reduce the number of late awards to approximately 50 percent.

solving the issues of today while paving the way for tomorrow NIAID’s unique integration strategy paid off in terms of meeting its functional, techni-cal, compliance, and cost-related require-ments. Using OpenText ECM Suite, NIAID has built a solid foundation for future document, collaboration, and business process improvement activities. It is the framework in which NIAID will continue to build repeatable and reusable applications that can horizontally and vertically scale throughout the Institute. Implementation of records management, transition from shared drives and personal email folders to the ECM system, and integration with enterprise disaster recovery and continuity of operation plans are all on the horizon. In the meantime, NIAID can feel confident that it can successfully meet its business challenges with staff and contractors who can now efficiently organize and securely store documents while sharing effortlessly among each other—no matter where their work may take them. n


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