Consequently, life science companies are turning to document or content management systems with workflow features to run more efficient organizations. Systems such as those from Canto, Documentum, Open Text, and Xerox, are being used primarily to create a searchable repository of files. Once a repository is in place, organizations will want to add a structured, collaborative system that efficiently manages and reuses the information throughout a drug's entire cycle, from R&D to post-approval marketing.
BREAKING DOWN THE WALLS:
BioMérieux's Ted Walsh wanted a way to manage content and to store information in a central location.
In particular, managers are looking for help from content management systems to provide a wide range of features such as workflow, collaboration tools, and some way to ensure that everything is compliant with regulations. "We wanted one place to go for information in the company," says Ted Walsh, global account manager for information systems at bioMérieux Inc. "We wanted to break down the silos [within the company] and find synergies."
BioMérieux makes biological diagnostic products for infectious diseases that are used in hospitals and clinical trials. The company routinely reuses information created for print documents on its Web site, but reusing information requires that certain checks and balances be in place. "We deal with infectious diseases, including AIDS and West Nile, so we have to be sure information that reaches the Web is accurate," Walsh says.
Walsh and other managers in the industry are finding that content is very often reused in many different formats. For instance, a portion of a printed document might be used as part of a warning or instruction label, on a Web site, or within an FDA submission. But in most companies, the people responsible for each of these areas seldom talk to their counterparts. So someone pulling together a warning label might not know how the information contained therein was derived or generated, or if it's in fact even correct.
If companies want to reuse information, there's a problem: Most companies handle documents generated in R&D, marketing, or for FDA submissions in very different ways. "In R&D, things are more fluid — it's the Wild West," says Martin Sumner-Smith, Open Text's vice president of pharmaceutical solutions.
|"Previously, without a document management system, people would review what they thought was the final document --but it wasn't. They would have the incorrect version."
Charlie Fusco, Otsuka Pharmaceutical
Hence the need for something beyond a searchable repository of corporate information. Companies need policies that govern the use of information and procedures as to how a document is deemed usable throughout the organization. "You need standard operating procedures," Sumner-Smith says.
In other industries, these policies and procedures might be based on good business practices. In the life sciences, the obvious requirement is to ensure that everything satisfies regulatory bodies such as the FDA and its counterparts abroad. "A lot of content that is created throughout [a life science organization] is regulated," says Andy Grygiel, Documentum's director of life sciences. "That means it will probably need to go under some type of 21 CFR Part 11 digital signature."
This requirement has a major effect on how life science companies handle their documents. "The FDA with 21 CFR Part 11 has made a huge impact on the type of system you [deploy]," says Julie Heck, a systems analyst at a large pharmaceutical company. (Heck requested her company not be named.) The FDA wants to know if and when a clinical study report has been modified. To do this, "you need to keep electronic copies and [use] life-cycle workflow procedures," Heck says.
Benefits to be Gained
Applying the same document-handling procedures throughout a company has several benefits. For example, bioMérieux has leveraged its adoption of standard operating procedures when publishing information to speed customer service.
The company ships a Certificate of Compliance with all of its diagnostic products. However, it is not uncommon for customers to lose or misplace the certificate, necessitating a call to bioMérieux to obtain a replacement. Today, bioMérieux publishes Certificates of Compliance on its Web site. "This takes a lot of work off our customer service center," Walsh says. He notes that bioMérieux can do this because "as long as it's in [the electronic document management system] and the system is 21 CFR Part 11 compliant, we can publish the new certificate to the Web."
Others are also looking at standard document-handling procedures to help them run more efficient operations. "Previously, without a document management system, people would review what they thought was the final document — but it wasn't," says Charlie Fusco, manager of IT at Otsuka Pharmaceutical. "They would have the incorrect version."
The Otsuka system is designed to allow people throughout a global organization to access documents. The key is the ability to set up and enforce standard operating procedures. But any implementation like this that cuts across different groups within the company requires plenty of upfront work. Fusco had planning sessions with representatives of different functional areas including safety, quality assurance, biostatistics, and R&D. He also sought input from end-users and department managers.
"We worked extensively on where we want certain documents kept," Fusco says. To reuse information throughout the entire organization, "you need compliance at all levels," he says. "To deploy a document management system, we needed to do software validation."
This was nothing out of the ordinary, but it did require planning. The process included saving screenshots of all installations, retaining and filing all installation logs, and validating that all hardware met the software vendor's requirements. Once everything was validated, a change-control process made sure that the system was kept compliant. In this way, a document that passes through the system is compliant and can be reused in any department, whether it needs 21 CFR Part 11 compliance or not.
Once such a system is in place, companies find they can use things such as workflow systems to their advantage. For example, in any filing, tracking information and the status of a document is very important. "We need to know, 'What did we give health authority X on day Y?'" Heck says.
Not only is this kind of information useful, but also, in some cases, the ability to know where everything stands, and where every document is, proves even more valuable. "If an item (a chemical element, for example) is no longer safe to use, we have to find where that information is in all drug submissions and make a change," Heck says.
If a company receives approval to sell an existing drug to a new age group (e.g., children five years of age and younger), or if there is a change of any kind, the ability to quickly find all the relevant documents is essential. "You're constantly asking, 'Where are we in a submission? Do we need to change our labeling? Do we need to file a new submission?'" Heck says.
Most life science companies focus a large effort on setting up formal procedures for managing normal documents. Typically, documents start life as Microsoft Word files, which then get reviewed, edited, and approved. Later on, many companies convert these files to Adobe Acrobat PDF format because of more options to lock down the content.
At some stage, work on a document is completed. "There's a point in time when you declare something is a record and you laminate it," Documentum's Grygiel says. "It never changes after that point." That usually results in a large collection of Word and PDF files, which is no problem for many document management systems.
But a shift is occurring that is altering some of the requirements for selecting a management system. For instance, bioMérieux's Walsh found that what started out as a traditional document management effort quickly expanded to include electronic documents, Web content, and rich media (such as artwork, packaging, and training information).
Incorporating these alternative types of data into one content management system allows bioMérieux to reuse information in additional ways. For example, products sold in Europe require a package insert with information in 10 languages. "We get the information in English, and put it into a workflow," Walsh says. "It goes to subsidiaries in the 10 countries to be translated into the native language." BioMérieux assembles the returned elements, and "we put them together as artwork as part of the package insert."
Indeed, it seems package labeling is the poster child for information reuse. "Labels have a clear structure, and there's great potential for reuse," says Tom Moore, practice manager for pharmaceutical document management at the consultancy Intra-sphere. "Warnings, precautions, adverse reactions, etc., all have the same components stated differently."
|"Labels have a clear structure, and there's great potential for reuse. Warnings, precautions, adverse reactions, etc., all have the same components stated differently."
Tom Moore, Intrasphere
Moore thinks XML is very well suited for such applications. And he sees an increasing need for systems that do a better job managing XML files. "We're moving in a direction where submissions, labels, and protocols are very highly structured," he says.
Today, most document systems that support these application areas are traditional, where a Word or PDF file is handled by a content management system. But as the industry starts to adopt electronic submission using, for example, electronic common technical document (eCTD) specifications, "companies must go through a Herculean effort to put information in the right form, and they must do that many times over," Moore says.
Indeed, when it comes to managing such documents, the pharmaceutical industry lags behind other industries such as automotive and manufacturing. These industries have lots of technical documents and continuously updated information that must be inserted into those documents.
Using eCTD within the life sciences would mean adopting a more granular approach to handling information. "With eCTD, you have documents broken down into very small fragments," Moore says.
Let's take the example of a clinical trial report. Currently, a revamped version might be sent to someone using Microsoft Word, who can see the modifications to the document by turning on the word processor's Track Changes option.
|XML Ideal for Data Chunks
|Standard procedure in preparing a new drug submission is to rely on Microsoft Word to create documents such as clinical trial study reports that make up a submission.
A better approach, Moore and others contend, would be to use a granular document and send only a page that lists which elements of the document changed, along with the date and version number of any changed items. But implementing such a change is unlikely to happen on a wide scale anytime soon.
Moore believes putting content into XML in repositories will help in such efforts (see "XML Ideal for Data Chunks").
Others, like Walsh, are already using traditional document management techniques in a granular approach to support multi-element package inserts, and are seeing the benefits of having a standard operating procedure and workflow policies in place throughout an organization.
For all the options available to manage information, the common thread that cuts through all applications is the need to ensure that proper policies and procedures are followed when information is created, approved, and saved. In that way, many groups within an organization can safely reuse the information, thus realizing the benefits of operational efficiency.
PHOTOGRAPH BY BOB RIVES