ECM Best Practices for the Enlightened Enterprise
Information overload in the life sciences industry is driving a pressing need for better content management. Companies are overwhelmed by content across the business, from clinical trials to regulatory submissions, to manufacturing, to marketing, to sales. All of this is made even more complex given that the vast majority of content is unstructured: 80%-90% percent, according to analysts. Life sciences companies have had to navigate complex internal and external pressures that further affect how they gather, store and access content. Among the difficulties besetting the industry are disruptions from mergers and acquisitions, shrinking pipelines, breakthrough technologies in research and development and global regulatory demands.
Despite all this, many life sciences companies have shied away from full-scale enterprise content management, choosing instead to deploy silos of departmental solutions. But today's pharmaceutical enterprise needs to operate without boundaries: between functions, divisions and operations and across the healthcare value chain. An organization that adopts a collaborative model such as this might be termed the "enlightened enterprise."
Finding Enlightenment
As the name implies, an enlightened enterprise is one that shares information, knowledge and data across the organization and with other partners in the chain. It is an organization that is transparent, extended and intelligent. The underpinnings of an enlightened enterprise include a clear and actionable enterprise content management (ECM) strategy that reflects an enterprise-wide, solution-deep philosophy.
In the enlightened enterprise, ECM takes place in a highly collaborative environment in which everyone benefits from a systematic method of managing, storing and accessing content that reduces total cost of ownership and increases return on investment. It starts with the enterprise's need for content management, knowledge management and collaboration.
ECM is supported by, firstly, a number of enabling technologies and tools; secondly, an underlying electronic document management system that easily integrates with other enterprise systems; and thirdly, supporting processes that can help life sciences organizations achieve incremental and immediate value from enterprise investments—not just departmental or functional benefits. ECM ultimately drives the way the entire enterprise can get smarter by leveraging the information that is hidden in systems spread across functions and around the globe.
Breakthroughs in ECM technologies enable enterprises to devote their time to bringing products to market rather than spending it on non-strategic areas such as data gathering, storage and retrieval. While some companies have taken the first step toward ECM by incorporating data from all of the business units in one repository, few have made the leap to a collaborative strategy that encompasses both internal and external parties or that considers interdepartmental relationships such as how savings in one area might lead to expenses in another.
However, while an ECM strategy will benefit companies in the long term, accomplishing this is neither quick nor easy. Companies must appreciate that ECM is a significant undertaking and there are important lessons to be learned in addressing content management in the life sciences. By taking advantage of the expertise of life-sciences specialists and of the experience of companies that have implemented ECM, companies can draw upon industry best practices as they press forward with efforts to manage their data, documents and knowledge.
Discovering the 10 Best Practices
Though the process of ECM implementation is time-consuming and will vary from company to company, there are several critical steps that an organization should take to facilitate ECM. The steps divide into 10 best practices—gleaned from industry leaders—that demystify the process. In addition, checkpoints should be put in place to ensure that each step is moving forward. A steering, or strategy, committee should be set up to oversee the program and identify bottlenecks, and it should include high-level representatives from throughout the organization, say Forrester analysts.
1. Establish the Vision
Start with an enterprise vision to ensure that the company will be taking a consistent approach to the content management solution. In establishing the vision, the representatives must recognize the importance of acknowledging the organization's pain points and its high-priority areas for the business. By developing an enterprise-wide goal that addresses what the enterprise is looking to achieve, the representatives will be better positioned to set in motion the process of sharing information across the industry silos that have prevailed.
2. Implement a Point Paradigm Approach
With the vision in place, it will be necessary to think strategically about aligning the organization for change. Rather than trying to solve the enterprise's content needs in one fell swoop, a company should start with the biggest pain points in the organization and allow the solution to evolve. At the same time, however, it is important to ensure that the starting points have a broad-enough scope and that there is high-level buy-in to ensure that the organization as a whole embraces the process.
3. Harmonize and Standardize Globally
It is important to build and design solutions step-by-step in a way that best fits the organization's needs and global reach. That will help the company determine the best repository design from an enterprise sales perspective. While harmonizing across the enterprise is the optimum goal, there might be instances when differences in vertical divisions will not make such harmonization possible. In these cases, those vertical departments should be given latitude to define their specific requirements. Nevertheless, it makes sense to establish a standardized guiding principle that can be built upon and tailored to each vertical team's requirements.
4. Select Enterprise Architecture Tools
Enterprise architecture refers to the data elements the enterprise is seeking to manage; how those elements interrelate—including data and metadata (or data about data); and how they support the enterprise's objectives with regard to the way the information is managed, stored and accessed. The technology suite that will support the ECM solution must be adaptable to the enterprise's needs and should meet end-user training needs. It should also have a tool-set that is predominant in the industry so it can be used not only by those across the organization but also by external partners, vendors and customers. The tools an enterprise selects should be consistent throughout each phase of implementation and as project updates occur. In addition, companies should have a centralized IT function to support implementation and maintain a common platform.
5. Pick Off-the-Shelf, Configurable Products
A series of off-the-shelf enterprise suites, referred to by analysts as smart suites, have emerged in the ECM marketplace in recent years, particularly in the life-sciences market. Analysts from research firm Gartner Inc. recommend that off-the-shelf suites make it possible to substantially reduce integration costs for support of extended enterprise processes for knowledge management, content management and collaboration. Those making the IT decisions should take the time to evaluate the choices available, selecting a package that is flexible and configurable to the enterprise as a whole.
6. Avoid Customizations
Past experiences have left companies wary of expensive and inflexible customized solutions. Not only can implementation, updating and migration to new technologies set a company back tens of millions of dollars, proprietary data formats can also create enormous difficulties with regard to sharing data across different platforms. Over the years, life sciences companies have adopted a mixed bag of information technology solutions from multiple vendors with proprietary data formats, making it next-to-impossible for data to be shared across the different platforms. Standardized systems embrace industry best practices and are designed to meet the growing regulatory requirements that weigh upon the industry.
7. Organize a Shared Service Model
From early on, it is important to bring in support staff who will manage and maintain the system after it goes live. Failure to bring such key support staff on board early on is often the reason systems are not embraced after initial deployment. Setting up a shared-services model helps with corporate buy-in and systems standardization, which in turn will help propel the success of the solution.
8. Assemble Well-Defined Teams
Deploying a large-scale initiative to manage a company's documents and data will hinge on the quality and commitment of the people put in place to initiate and carry out the project. It is therefore vital to clarify roles and responsibilities and ensure strong, continuous communications throughout the program. First, the project team is paramount. The deployment teams must understand the geography, where requirements might differ, and whether there are limitations or benefits to certain aspects of the project. Before deployment, it is important to ensure that users are properly trained and that any gaps between the project team and end users have been bridged. Finally, the support team must be well-defined and established before rolling out the ECM solution.
9. Don't Overlook Migration and Deployment
Companies often forget about the migration effort until the very end. This is a mistake because in almost every case, deployment turns out to be more complex than companies anticipated. Failing to plan migration and deployment early enough will mean important content may not have been transferred to the new ECM system, thereby defeating one of the key purposes of an ECM solution, which is to have centralized access to all of the knowledge, information and data that exist within the organization and with partners. Early on, the decision-makers should determine which tools should be migrated to the new content management system and which should be retired.
10. Keep Ownership at the Business Level
ECM should not be seen as an IT initiative. Despite the huge amount of money an enterprise might invest in an ECM solution, such programs often fail when a project is viewed solely from a technology perspective rather than as a business function that is supported by technology. With ownership at the business level, it becomes possible to derive the drive and passion needed to ensure the solution is embraced across the business.
It's All in the Planning
While ECM as a concept is becoming increasingly recognized for the value it can bring to the life sciences industry, disjointed decision-making and poor implementation have left many companies disillusioned about what ECM can do for their organization. Careful planning that begins at the senior level and permeates throughout the organization as well as adherence to best practices will enable life sciences companies to avoid the pitfalls of systems updates and become truly "enlightened enterprises."
FCG Best Practices in Action
A top-10 pharmaceutical company began ECM implementation by building its vision, with a focus on rapid return on investment from an enterprise perspective. The company standardized on an enterprise platform and from that developed a two-pronged approach: (1) Process-centric content management for the core business needs within the organization, including research and development data, submission data, manufacturing for standard operating procedures and marketing and sales material for advertising and promotion; and (2) a "process-lite" approach, or lightweight document management system, for internal operations such as legal contracts, budgetary information and human resources policies. A leading pharmaceutical company began with a solution for submissions and global manufacturing and quickly found that because the solutions were scalable, they could share information across silos and expand into other arenas without interruption to workflow. In addition, the company has since implemented a content management solution for sales and marketing. The adoption of interoperable solutions across departments has led to savings of more than $1 million a year from cuts to production costs and has improved regulatory compliance through better access to information.
First Consulting Group is an industry-leading professional services firm focused on helping healthcare providers, health plan insurers, government healthcare, and life sciences companies solve complex business issues. To download the entire Best Practices white paper, visit www.fcg.com/ecmbestpracticeskm or visit www.fcg.com