For pharmaceutical companies, documentation is crucial. In developing and testing new drugs, regulators require an audit trail to ensure that procedures are followed right down the line.
“”Any type of procedure that we perform here, in any department of the company, has to be well documented,””
said A.J. Simon, director of information technology at Isotechnika Inc., an Edmonton-based biopharmaceuticals company that develops immunosuppressive treatments such as anti-rejection drugs for organ transplants.
Until last year, Isotechnika relied on storing all the required documents on a file server, with a table of contents to help find them. Not satisfied with this “”very basic”” system, the company has adopted some new technology from Microsoft Corp. to improve its document management.
One key is InfoPath, an application released with Microsoft Office System 2003. Based on Extensible Markup Language (XML), InfoPath can create forms for entering and managing data. Simon said Isotechnika uses InfoPath to create forms which are the main documents used to collect information throughout processes such as drug development and testing.
Microsoft’s SharePoint Services, a collaboration system provided with Windows Server 2003 or with the company’s SharePoint Portal Server, is a way to make documents available to whoever needs them. Kevin Hunter, product manager for Windows System Server at Microsoft Canada Co. in Mississauga, Ont., said SharePoint both allows companies to post official information such as human resources policies and provides for work groups to create informal collaboration areas to share information and meet online.
Simon said Microsoft’s digital rights management technology is also important to his company’s application, allowing Isotechnika to ensure the integrity of documents created in Microsoft Word. In the past, he said, the drug developer had to convert documents to Adobe Systems Inc.’s PDF format to ensure they were not changed.
Isotechnika upgraded to Windows Server 2003 to make the system possible. Simon estimated the total cost, including server upgrades, at around $50,000.
Simon said the system now creates a history of document versions and a complete audit trail automatically. “”It won’t be a manual process any more.”” This means Isotechnika staff can spend more time on research rather than on administrative tasks.
Compugen Inc., an Edmonton-based systems integrator and Microsoft partner, helped develop the system. Tim Peterson, senior consultant at Compugen, said his company’s early adopter program provided Isotechnika with pre-release access to InfoPath and SharePoint Services, allowing the company to begin testing last summer and have the system ready to accept data by February 2004. Implementation took three to four months, Peterson said.
Peterson said customers have shown considerable interest in the document management capabilities of the latest Windows releases. Compugen had nine customers involved in its early adopter program, he said.
Mike Bulmer, product manager for Microsoft Office System at Microsoft Canada, said InfoPath has applications in almost any industry. “”Pretty much anyone can quickly see processes within their companies that can gain from having data collected”” using InfoPath forms, he said.
Hunter said SharePoint Services is also broadly applicable, with work groups turning to it to build collaboration platforms for various purposes.
Simon said about 85 people – “”basically everyone in our company”” – uses the new document management system. He noted that he has seen more specialized document management tools in use at other pharmaceuticals companies, but “”I find this more beneficial.””