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Genzyme streamlines business processes with collaboration, knowledge management system. (Editor's spotlight: 21 CFR Part 11).

Genzyme Corporation has embraced collaboration and knowledge management technology to improve operations and to support FDA compliance. Since 1995, the company has evolved its use to improve operations and to make the system a fundamental part of the way people work at the company. Genzyme's efforts are a case study for how pharmaceutical companies can embrace a technology, evolve it to their needs and use it effectively to meet growing challenges.

Genzyme, like many pharmaceutical companies, has been looking to new IT technology to help improve productivity. The need for powerful but easy to use computing solutions to speed drug discovery, to improve manufacturing processes, and to realize supply chain efficiencies is becoming paramount. Process automation for research and development, supply chain management and services execution are key organizational requirements. But success also hinges on the technologies used to store, analyze, interpret and share information as part of automated processes--that's where collaboration and knowledge management come in to play.

The drive to bring new products to market faster is behind Genzyme's strategy of adopting collaboration and knowledge management, and integrating it into its operations. Knowledge management and collaboration software helps companies improve the way their teams work together, manage and share information, while making critical information immediately accessible and providing dynamic ways to use that information. These benefits can be obtained whether users work together in real time or asynchronously. The impact on operations can be dramatic in an industry, such as pharmaceuticals, where regulatory requirements and the demands of managing huge volumes of information are sometimes at odds with the industry's rapid time-to-market demands.

Genzyme uses Open Text's Livelink as its designated knowledge management and collaboration standard. Livelink provides a broad platform that integrates online team collaboration tools with knowledge/document management, records management, and other capabilities such as business process automation, enterprise group scheduling and information retrieval services.

Scaling for Team Collaboration

In recent years, Genzyme has experienced tremendous growth and Livelink has been growing with it to accommodate the company's growing number of projects. Livelink is highly scalable, in part, because it's Web-based and integrates easily with a wide range of systems. Over the last few years, the company has doubled its Livelink user base in order to manage the rapid increase in both employees and the number of research projects underway.

Livelink has been useful to teams within Genzyme using team collaboration capabilities in Livelink to help manage projects. Livelink's project areas provide an online environment for these teams to collaborate on critical documents. The result has been greater efficiency and less time "reinventing the wheel." These project workspaces give users a sense of "place" online, which helps teams stay organized and operate more effectively. At the same time, because workspaces are integrated with Livelink's knowledge management capabilities, the company can capture information generated by project teams, so that it can be stored and leveraged as part of the company's knowledge base.

The Library

Superior security features enable Genzyme to use Livelink as its central library. With appropriate permissions, Genzyme employees around the world can access regulatory submission development, correspondence, filings and other critical documents without compromising confidential and proprietary information. And Livelink's document management capabilities support Genzyme's compliance with the FDA's mandate for electronic records requirements. Other information employees can access include: Standard operating procedures (SOPs) and manufacturing documentation, which promotes quality processes across the organization; and global development plans, which includes information such as engineering and project related documents for the construction of new factories.

Improving User Adoption

Genzyme has also implemented capabilities that give employees one-click access to Livelink functionality directly from Microsoft Office, and applications such as Word, Excel and PowerPoint. This has been important to Genzyme's efforts to make online knowledge management and collaboration a part of the culture and a way of doing business, because it integrates Livelink with applications employees most often use. A successful collaboration and knowledge management solution depends upon how well the technology is accepted by its users.

Integrating Livelink with common applications improves user adoption, ensuring that the technology becomes the standard way of working together, not just a tool for occasional use.

E-Signatures

Genzyme is currently developing Livelink workflows to automate and standardize business processes across the organization. Plans are also being considered for implementing Livelink eSign to improve efficiency and speed approval processes. Meeting the FDA's 21 CFR Part 11 rules, Livelink eSign gives companies an electronic process for managing legally binding e-signatures across a large enterprise.

Records that pharmaceutical companies keep and the electronic signatures that are applied to them must comply with the regulations in 21 CFR Part 11 by ensuring that: 1) The software products function in a way that enables them to comply with the requirements of 21 CFR Part 11; and 2) Policies and procedures are in place to ensure that the software is deployed and validated to perform in the required manner, and that users are trained and required to use it according to defined and expected processes. Where electronic signatures come in to play, this can get tricky. Electronic Signatures are any symbol or series of symbols authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. An effective e-signatures solution requires an entire system of controls, checks and balances that are essentially an audit trail. Solutions must be integrated with security, workflows and other features.

With Livelink eSign, users collaborating in Livelink can easily follow processes for document certification and management that meet regulatory requirements. The product provides detailed signing workflows, which can be initiated directly from a document requiring a signature. When setting up a workflow, users are able to choose authorized signers from a pre-established list. Once a document is signed, the signature is recorded in audit trail logs, which include the signer's name, title, the date and time of signing, and the meaning of the signing, as well as a link to the signing workflow. Livelink eSign also offers security features to ensure electronic signatures are authentic, including name and password authentication for each signer, each time a document is approved. A special "signing password" can also be required of all document signers for added security.

Genzyme, and pharmaceutical companies in general, play an important role in evolving solutions such as Livelink, and in the development of specific tools such as Livelink eSign to serve their needs. Trends in the industry will continue to require new solutions. According to Gartner, IT-enabled marketing and research and development are among the factors that will have the greatest impact on pharmaceutical companies over the next few years. It's easy to see why when you consider the challenges of the industry: Average expenditures to get a drug to market are about $800 million over a 10-15 year drug approval lifecycle. Only one third of drugs that make it to market deliver a positive return on investment. Because the research and development process is so prone to data and process inefficiencies, it's ripe for the kind of process improvements, and corresponding cost reductions, new IT solutions can deliver. By finding innovative ways of adopting and integrating new technology, such as collaboration and knowledge management tools, companies such as Genzyme are creating process improvements that can give them a competitive edge.

Open Text Corporation, 185 Columbia Street West, Waterloo, Ontario, Canada, N2L 5Z5.

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Martin Sumner Smith,
Vice President
Pharmaceutical Solutions
Open Text Corporation
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Author:Smith, Martin Sumner
Publication:Pharmaceutical Processing
Geographic Code:1USA
Date:Feb 1, 2003
Words:1235
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