While a broad enterprise content management (ECM) solution is needed in some business environments, an industry-specific or vertical solution works better in others. Those software products are geared to be functional right out of the box, with a minimum of customization. They have particular advantages for small organizations that do not have extensive in-house IT capabilities. Vertical solutions can often be up and running in a matter of days, a benefit when time is a crucial factor.
In the pharmaceutical industry, it’s all about time to market. Each lost day of sales counts against the balance sheet. Therefore, companies carrying out research and development benefit when the process of gaining approval of new drug applications is handled efficiently. A well-tailored document management system can go a long way toward expediting development while ensuring compliance.
Alimera Sciences, which specializes in prescription ophthalmic pharmaceuticals, is currently conducting Phase 3 clinical trials with an ophthalmic drug product for diabetic macular edema. In the highly regulated pharmaceutical industry, the company must carefully document its standard operating policies and procedures, as well as training for all employees.
Although the firm had been using a manual system of filing paper documents, several of its employees had worked at companies that used electronic document management systems and were familiar with their benefits. Barbara Bauschka, regulatory affairs associate director at Alimera Sciences, began exploring several options for an electronic document management solution.
After networking with some colleagues in the Drug Information Association, Bauschka developed a list of a half-dozen candidate products and began researching each one. She zeroed in on PharmaReady DMS from Take Solutions, based on functionality and cost. In addition to PharmaReady DMS, the PharmaReady suite includes the Electronic Common Technical Document (eCTD) solution for e-submission of applications to the U.S. Food and Drug Administration (FDA) and several other products.
PharmaReady DMS is built on Microsoft technology and is compliant with 21 CFR Part 11, which addresses the maintenance of electronic records for industries regulated by the FDA. More specifically, Part 11 tells manufacturers the steps to take to ensure record authenticity, integrity and confidentiality. PharmaReady DMS manages SOPs, work instructions and other documents needed by the life sciences industry in a way that complies with those FDA regulations.
All of Alimera’s SOPs and required forms are in the PharmaReady DMS, including test methods, protocols, manufacturing batch records and other documentation. The system also contains documents submitted by external contract companies for Alimera to approve.
"From an IT perspective, the system was very easy to install," says Bauschka. "We already had Microsoft SQL Server in place, and the performance of the PharmaReady document management solution utilizing Windows SharePoint Services has been very good."
An important aspect of compliance is to ensure that employees read any documents that provide new information on operating procedures. "Notification of a new document comes from PharmaReady," says Bauschka, "and the employee clicks a link to access the document."
After reviewing the information, employees verify they have read and understood the document and may also complete an assessment. That verification and assessment are then routed to their training file. PharmaReady DMS also controls who can edit documents in a way that is consistent with CFR Part 11.
"Having the compliance function built into the application saves us time and ensures that we are operating in a manner that is consistent with FDA regulations," Bauschka states.
Although PharmaReady products can serve global life sciences companies, they are aimed at small to midsize pharmaceutical companies, which constitute an underserved market with respect to vertical document management solutions.
"Specialized document management systems have been available for large pharmaceutical firms for a decade or more," says Rob MacDougall, executive VP for sales and marketing in the PharmaReady division, "but not for the smaller ones. We saw a real need for a similar product that was affordable and provided the same assurance of compliance."
Customers had in fact asked for such a solution. "We believed that the right ingredients were a Microsoft-centric product and a simple licensing model," MacDougall adds. "The Microsoft components all work well together, and the result is a cost-effective and efficient solution."
Content for transactions
Hyland Software has been building out its OnBase software suite for nearly 20 years to offer a broad range of functionality for specific businesses. In the insurance industry, for example, OnBase organizes materials by case, so that an agent can see forms, letters and video clips associated with a particular claim.
"Our solution is geared toward managing transactional content that is used in association with business processes," says Ken Burns, industry communications director at Hyland. "OnBase organizes and handles documents as correlated sets associated with a particular account, transaction or event."
It then links those documents with corresponding data managed by the primary line-of-business (LOB) application for a given process. "OnBase ensures that documents and application data will be managed in concert with one another throughout their life cycle," Burns explains.
To meet the needs of users in a given vertical, OnBase integrates with the primary applications used in that industry. "Our healthcare application is integrated with the leading healthcare records management system," Burns points out. "For finance and administrative businesses, we integrate with ERPs or business suites."
In law enforcement, the vertical application is forms-oriented. "Police officers typically carry a large number of forms with them to cover various types of incident reports, and then they have to re-enter the data electronically when they get back to the station," Burns says. "Our field reporting application lets them enter the data on a laptop in the squad car. At the station when they dock the computer, it automatically downloads the information and kicks off a workflow."