Large and expensive enterprise document management systems provide a powerful solution for the massive amounts of documentation required to conform to the Food and Drug Administration's (FDA's) quality system requirements. But these systems are generally far too expensive to purchase, customize and maintain for small medical device manufacturers.

Oncogene Science (Cambridge, MA), a manufacturer of oncology assays for the clinical immunodiagnostic market, overcame this problem by implementing an off-the-shelf document management solution. "Going paperless has saved immeasurable amounts of time while ensuring a highly reliable level of accuracy and control than can be achieved with paper-based systems," says Don Tenney, manager of manufacturing for Oncogene Science.

The FDA's quality system requirements for medical device manufacturers help ensure that medical devices are safe and effective for their intended use. In essence, medical device manufacturers must document every aspect of their business from management to shipping to customer satisfaction. For example, Oncogene Science is required to document every formulation, every manufacturing process, every test procedure, labeling for each bottle, how to use every piece of equipment, how to manage the company's facilities and how the company conducts corrective actions.

The outcome is that the company, with only 20 employees, uses more than 1,300 different documents. When the company first began manufacturing it tried managing these documents manually using a paper-based archive.

"We quickly discovered that managing even a small volume of documents was an impossible task for a company of our size," Tenney says. "There is an enormous amount of labor involved in copying documents, filing documents, retrieving documents, routing documents to the person who needs them and many other tasks. Manual document management is also prone to errors such as losing documents, using outdated versions of documents and assembling documents with pages missing."

The company faced a difficult challenge early on after it determined that it would not be practical to operate with a manual document management system. "We looked at various alternatives and discovered that the Powerway Document Manager and associated desktop met all of our requirements at a low cost, required no customization and had a minimal investment in installation, verification and training," Tenney says.

Powerway Document Manager provides a secure environment for document authoring, change control, revision history and audit trail for each document. The administrator function in Document Manager controls permissions for individual consumers and producers, as well as search criteria and designation of document file storage locations called binders.

Configuring the software was a relatively simple process. The first step was defining a hierarchical structure for the company's documents and entering their naming conventions content. For each type of document, various individuals in the company are designated as producers, consumers or administrators. Consumers have read and print-only access to the latest versions of the documents. Producers are responsible for creating, changing and registering documents and have access to all revisions of each document.

Documents are distributed across the network through every step in their life cycle. The access privileges to the documents are controlled by the system administrator. Obsolete documents are hidden automatically. When a revision to a document is released, the previous version is stored in the system repository and can only be recalled by those with producer privileges. A unique indexing scheme provides fast and easy retrieval of documents with user-defined query filters. Documents may be configured with an effective date that automatically releases the approved version and removes the obsolete version from circulation.

Some of the greatest timesavings were experienced during the approval process. For each class of documents, an approval workflow was configured that routes the draft from the producer to others in the organization who need to review and approve it. The document management system provides a platform for obtaining input from approvers while maintaining an audit trail of all changes. Producers can check out documents for editing, and while these documents are checked out, they cannot be modified by others. Document distribution is carefully controlled so that documents cannot be released until they have been approved by appropriate individuals and earlier revisions of documents cannot be distributed.

"The program routes documents to people selected by the producer, automatically notifies reviewers and makes it easy to see exactly where the approval process stands," Tenney says. "Everyone involved in the approval process can see who has approved or rejected a document and can also see any comments they might have made. The result is a large increase in the speed documents move through the approval process and a corresponding reduction in the time that our managers have to devote to document approval."

The document management system also has substantially reduced the time required to develop a robust quality system and achieve ISO 9001: 2000 certification. Document control plays a key role in a quality system. This new system provides a level of control that meets their requirements. "The document management system also saves time during inspections by allowing us to access documents requested by the inspectors in a matter of seconds," Tenney says.

"For obvious reasons, quality systems regulations place the same requirements on both large and small companies," Tenney says. "While a complicated and expensive enterprise document management system could make sense for the largest companies, smaller companies need a less expensive system that can be deployed in less time. The Powerway Document Manager and Desktop system meets our needs by delivering substantial time savings and improvements in accuracy by helping us go paperless at a cost and administrative workload that is appropriate to a company of our size."

Benefits

• The document management system allows operators to access documents requested by the inspectors in seconds.
• Everyone involved in the approval process can see who has approved or rejected a document and can see any of their comments.
• The document management system has substantially reduced the time to achieve ISO 9001: 2000 certification.
• The system has a low cost, requires no customization and has a minimal investment in installation, verification and training.

Powerway Inc.
(800) 964-9004
www.powerwayinc.com
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