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True efficiency requires the move to a company-wide ECM solution that supports the entire content lifecycle.
Over the past 10 years, the life sciences industry has faced the twin forces of fierce competition and ever increasing regulatory pressures. To get products to market faster and foster deeper innovation, a higher level of collaboration needs to occur between a company's traditional silos of information, and this collaboration needs to include outside partners and their extended business ecosystems.
At the same time, pharmaceutical firms must be acutely aware of industry regulations and standards set by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). The management of information is essential to reduce compliance risks and improve submissions to these regulatory agencies.
Photography: Getty Images Illustration: Paul A. Belci
With the advent of more robust discovery tools such as high throughput screening, the increased volume of information available from the human genome project, and the amount of unstructured content in the form of complex documents existing in multiple revisions within the enterprise, there is an explosion of information. This, coupled with the desire for companies to differentiate themselves through the creation and protection of intellectual property, leads to many firms becoming bogged down when it comes to managing content.
Through our many conversations with multiple customers across the industry, it has become clear that there are multiple versions of the corporate truth with respect to discovery, development, sales and marketing, and manufacturing. There are multiple data vendors, with varying data formats, all of which must be utilized in the enterprise management of content. This has shown that data inconsistencies, as well as a lack of discoverability, categorization, and dependability, have become the norm rather than the exception.
In such an environment, the need for pharmaceutical and biotechnology companies to better manage their documents and content is greater than ever. This has opened the door for next generation enterprise content management (ECM) solutions—solutions that better adapt to how researchers, marketers, clinicians, and other employees work, while seamlessly adhering to regulatory requirements.
Poorly managed data is most problematic when submitting content to regulatory agencies like the FDA. According to several of our customers, there are multiple documents that make up the entire electronic common technical document (eCTD) submission. These documents are linked to one another in that they refer to one another and are therefore linked. This link is maintained as part of the submission. A typical FDA submission can contain more than 100,000 links. Companies have to manually check the links before finalizing submissions and turning them over to the government. Moreover, they have to find a way to relate unstructured content stored in file systems, users' computers, and content management systems to other content located throughout the organization.
Three Keys to ECM Success
A typical submission requires input from many people that spans departments, organizations, and years. All of the documents in a New Drug Application (NDA) submission, for example, need to be reviewed by various people in the organization before they are included in the submission. The movement of these documents around the organization and the sign off and approval that must happen during that movement constitute a workflow. Today, submission workflow is an incredibly inefficient process. It consists mainly of authoring a document in Microsoft Office Word, rendering the document to PDF, and then setting links using a multitude of Adobe Acrobat plug-ins. If the relative path of the target document changes after the links are set, the links break.
The ultimate goal, of course, is to meet the requirements of an eCTD submission, which can be found at http://estri.ich.org/eCTD/eCTD_Specification_v3_2.pdf. An unstructured content authoring environment, however, makes it difficult to create intelligent documents without major customization.
What's needed is a central and trusted repository for all content that is subject to regulation. A central and trusted repository is secure and validated. It is available across the organization to those individuals who need to have the information. It can be audited at any time and the movement of documents in and out of this repository can be tracked and detailed. The content should be moved to and managed in this repository based on metadata and lifecycle rules. For example, what is the status of a particular piece of content? Which is the original and which are the copies? Where is the latest approved version of a document? A large portion of corporate content is redundant, and there is no way to know which document is the authoritative original.
Life science organizations must realize that the ECM lifecycle is extensive, with the ability to move information from creation and capture to management, to sharing and collaboration, to publication, and to archival or disposal. These considerations have forced organizations to review the challenges of content management within their enterprises and move beyond traditional filing and document repository systems.
The digital age has brought with it a wealth of content in a multitude of formats, such as images, text documents, Web pages, spreadsheets, presentations, graphics, drawings, email, instant messages, video, and multimedia. The magnitude of structured and unstructured content can be complex and difficult for organizations to manage.
Life science organizations have considered many strategies on how to structure and manage the content they generate and consume, both from a recordkeeping and a document management standpoint. In the context of an overall ECM strategy, organizations need to address explicit requirements within three major areas: document management, records management, and forms management.
In records management, for instance, some of the particular requirements include establishing retention and expiration policies and minimizing outdated information within the organization. These specific requirements and others could all be addressed with an ECM solution, by maintaining a controlled environment wherein access is based on roles and is time-bound—one can control who sees the information and in what time frame that information is available. Once a document reaches its expiration, it can be moved (through business rules that are part of the system) to a repository that can only be accessed through auditing and not be accessed for reference as a live document. That way it is retained but not used. With an ECM solution, one can "time-bomb" documents so that they cannot be referenced or used passed a certain date.
The requirements of 21 CFR Part 11 on industries regulated by the FDA has been wide-ranging. The rule affects electronic records stored in databases as well as electronic records created by word processors, spreadsheets, and graphics programs. The capabilities of conventional productivity applications need to be supported by a solution that can control the integrity and security of electronic records authored in those tools.
Regulatory requirements and legislation, such as the Sarbanes-Oxley Act, have changed ECM from an optional nice-to-have capability, to a must-have system. Enforceable document retention policies, consistent records management, and systems for managing unstructured information are all requirements from the standpoint of compliance legislation and regulations.
Although legislative requirements are a major factor, there are other reasons to consider an ECM solution. Organizations need to exert control over a massive volume of records and documents as a way to reduce task duplication and minimize the time employees waste looking for out-of-date documents or, worse, recreating documents.
In addition, managing content helps ensure that the right information in the right format reaches the right decision makers. After decisions are made, content management practices help preserve the why, when, and how of those decisions.
Another challenge that a life science organization needs to overcome is integrating the various components of an ECM solution. For example, an organization might start by implementing a records management solution and then quickly find that they also need collaboration capabilities to develop content that is under records management.
In our many conversations with industry players, it is clear that in many cases an organization has more than one ECM solution in place that span across multiple departments. This is sometimes due to the tendency of the industry toward inorganic growth through acquisitions, but it is also due to multiple departments with different IT initiatives. As an organization moves toward having a company-wide ECM strategy, it becomes important for a new solution to interoperate with existing solutions using industry standards. Organizations need to gradually build up their ECM strategy by deploying components in a way that doesn't require constant user retraining or pose an architectural and deployment challenge for IT.
Finally, user acceptance of a solution is among the largest challenges. Even if users accept implementing an ECM solution in principle, they will not embrace a system unless it can be integrated well with their current work styles. A solution must be intuitive and should not require users to rely heavily on their IT departments.
The solution must also fit into the organizational culture. For example, an organization that operates with strong individual teams is not likely to embrace a solution that is rolled out to the entire enterprise. These same departments, however, might embrace a solution that makes collaboration easier for their teams. Because user adoption is essential to the success of a solution, ensuring that users recognize the usefulness of ECM in streamlining their workloads is very important.
There are five main components of a good ECM solution: metadata management, document management, records management, forms management, and discoverability. Here's a brief summary of the capabilities each component should provide:
Metadata management. The ability to detect, create, and manage metadata is the cornerstone of any good ECM system. The fully integrated system will detect metadata during the authoring process, suggesting the metadata as the user types, thus reducing the need for end users to manually input metadata when they save the document—a task that usually goes unfinished. This system will also help companies avoid the taxonomy wars that often accompany traditional metadata management systems by utilizing search technologies to automatically build out the taxonomy of the metadata, which can then be reviewed and managed and the metadata versioned by the appropriate experts.
This metadata can then be used throughout the document or content lifecycle: discovering the information, filtering the results of content searches, and driving workflow and lifecycle management. The key is to make the creation of metadata as easy for the end-user as possible.
Document management. Document management capabilities harness the collective expertise of the organization and facilitate collaboration through document check-in and check-out, version control, and out-of-the box workflows to automate the approval and review processes. Centralized repositories also improve information discovery. Policies can be set that facilitate a document's tracking throughout the organization by using labels and barcodes. Additionally, centralized and managed storage results in an increased ability to predict storage requirements and better protect information assets against unauthorized use and inadvertent loss through item level security and information rights management.
For example, life science companies can use this feature to create a document repository, a central location for storing organizational content such as clinical trial reports. Users can then define document sets based on their shared behaviors and apply consistent metadata for categorization. Each content type can specify a document template, a schema, edit and display forms, policies, workflow processes, and even customized behaviors.
Records management. Today, with the need to ensure compliance with government regulations such as 21 CFR Part 11 and Sarbanes-Oxley, organizations are starting to give high priority to their records management. Imperatives in this area include clearly assigning responsibility for records management, continuously updating records to minimize outdated information within the organization, and maximizing transparency to protect the organization from audit and legal worries. Finally, a records management policy ensures the preservation of vital company information, which in turn ensures business continuity in the case of disaster.
Life science companies can use this feature to create a records repository that ensures the integrity of the files stored within it. First, it ensures that records are never automatically modified by the system, which means that records uploaded to a records repository and then downloaded again later will be identical. Second, it has default settings that prevent direct tampering of records by versioning a document when changes are made to its contents and by auditing specific types of changes. Default permissions are also in place to ensure that only records managers have delete rights, and even this action is audited. Finally, records managers can add and maintain metadata on items separately from the record's metadata so that information such as ownership can be changed without modifying the underlying record.
Forms management. Forms are a main component of any business process and are typically used to capture and validate the data driving the process. They usually hide the complexities of the business process that sits behind it.
A life sciences company can use this feature to reach more customers, partners, and suppliers, among others. Organizations can create forms that can be filled out with a variety of Web browsers, enabling a large number of people to initiate business processes such as entering a customer service request. This work can occur through the Internet, an extranet or an intranet.
Discoverability. This is one of the last frontiers of document management systems—and it is termed discoverability and not search for a reason. Discoverability implies that the document or content (or the expert generating the information) can be found easily. It goes beyond traditional search: finding precisely the right document through metadata filtering, finding the experts responsible for producing that document or, more importantly, for producing other information that may be needed. It also goes beyond the traditional search metaphor by allowing discoverability to happen in context during the authoring of the document or during the construction of the submission, instead of through an out-of-context "search" screen.
A good ECM solution supports the entire content lifecycle, from creation through collaboration, management, publication, reuse, archiving, and expiration. Although enterprise content management might seem like a daunting task, organizations are starting to understand that ECM is integral to business processes and essential to business success.
Michael Naimoli* is director, life sciences industry solutions, at Microsoft Corporation, 45 Liberty Boulevard, Suite 210, Malvern, PA 19355. Gabor Fari is also with Microsoft, serving as industry market development manager within the health & life sciences industry unit.
*To whom all correspondence should be addressed.