Healthcare Industry Case Study
/ DNA Pioneer Sees 10-Month Payback on FDA-Compliant Document Management System
“[Our business users] now smile when it comes to locating documents, because they can do it themselves and get an immediate response, rather than having towait for the Document Control Center to accommodate them.”
Padmaja Surapaneni, Senior Director of Applications, Affymetrix
Affymetrix, a pioneer in DNA analysis technology, needed a document management system that could accommodate its continued growth while meeting strict government regulations. It found that solution by migrating from Documentum to Microsoft® Office SharePoint® Server 2007. The new system has a projected payback in 10 months. Search time has been cut by 33 percent, and the solution provides long-term scalability.
This case study is for informational purposes only. MICROSOFT MAKES NO WARRANTIES, EXPRESS OR IMPLIED, IN THIS SUMMARY.Document published September 2009
Business Needs
Affymetrix commercialized the first DNA microarray in the late 1980s, and today remains at the forefront of technological and scientific innovation in genetic analysis. But the document management system that it used to manage much of this work wasn’t nearly as innovative.
Any company that produces products for the genetic analysis market must meet a battery of government regulations. In the area of document management, Affymetrix must adhere to strict regulations set by the U.S. Food and Drug Administration (FDA). Any document management system needs to comply with Part 11 of Title 21 of the U.S. Code of Federal Regulations (21 CFR Part 11), which determines the rules for electronic records. These rules cover system access authorization, document audit trails, electronic signatures, and validation requirements for computer systems.
Affymetrix had been meeting these requirements through manual processes and a legacy document management solution based on Documentum software. However, employees found the metadata and search capabilities of that solution limited. Because Documentum was difficult to use, they instead stored some documents on file shares and local drives. This greatly inflated the costs associated with meeting internal and external audits.
Affymetrix maintained a separate portal to give employees easier access to the document repository, meaning it had two document environments to maintain. The company had little internal expertise with Documentum, however, which put Affymetrix at risk when vendors stopped supporting the platform. So, Affymetrix began exploring its options.
Solution
Affymetrix wanted a document management solution with a built-in portal, to reduce the time and expense it was currently incurring to manage two separate solutions. It wanted metadata and search capabilities that would make it easy to locate documents quickly. It wanted a scalable solution for a 50,000-document database that was growing at 10 percent per year. And it wanted a solution that would facilitate organizing documents easily into the FDA-approved taxonomy.
Affymetrix was already deploying Microsoft® Office SharePoint® Server 2007 for its non–FDA-controlled documents, and it easily envisioned extending the benefits of the software to its FDA-controlled environment. The company held a Strategy Briefing at the Microsoft Technology Center where plans were confirmed for using Office SharePoint Server 2007 as the basis for the company’s new document management architecture.
One of the key tasks of the document migration was cleaning and validating all the original documents so they could be accepted into the new system. Affymetrix created a taxonomy that facilitates meeting FDA requirements and scales to accommodate future documents. A series of metadata tags was created for each document type, and, as documents were imported into the new taxonomy, the documents were automatically tagged to facilitate future searches.
With the document management system in place, the company’s current priority is to create an automated change-order process to replace its manual system. The system will use an Office SharePoint Server–based workflow to move digitally signed change orders through the Affymetrix management structure, with automated notifications replacing forms that must be faxed or mailed between offices. The system will capture data related to change orders—meeting an important FDA requirement—and store that information in a separate database, where it will be available for internal or external audits.
Benefits
Having completed the migration of its document repository from Documentum to Office SharePoint Server, Affymetrix sees a payback period of 10 months. The return comes mainly from enabling business users to search for and retrieve documents entirely by themselves. Previously, even with help from the IT department, the typical business user spent 1.5 hours on average per week searching for FDA-controlled documents. With workers using enterprise search in Office SharePoint Server, that figure has been cut by one-third.
Conducting faster searches has saved the equivalent of two fulltime positions with the new system. With the change order workflow capabilities, the company estimates saving 50 percent of what it took to process change orders in the manual and Documentum environment.
“When you consider that we have 60 percent of our 1,100 employees conducting searches each week, that adds up to a considerable savings of time and money,” says Padmaja Surapaneni, Senior Director of Applications, Affymetrix. “But the biggest benefit is in the faces of our business users—they now smile when it comes to locating documents, because they can do it themselves and get an immediate response, rather than having to wait for the Document Control Center to accommodate them.”
Audrey Sato, the Affymetrix Program Manager for SharePoint, sees another benefit from the migration: “We see an increase in our new product introductions and company acquisitions, which means an increase in the load of FDA-controlled documentation. We could not handle this increase in business without the shift to Office SharePoint Server.”
The return on investment could potentially accelerate to a payback period of 8 months once Affymetrix rolls out its automated change-order process system. “We’ll save from change orders being processed more quickly, with less human intervention,” says Michael Vedda, Chief Information Officer, Affymetrix. “We’ll save even more in accommodating audits and remediating our change orders in response to audits.” He sees Office SharePoint Server providing scalability—and support—well into the future. “Further growth will mean only cost-effective additions of hardware.”
This case study is for informational purposes only. MICROSOFT MAKES NO WARRANTIES, EXPRESS OR IMPLIED, IN THIS SUMMARY.Document published September 2009