Oncogene Science

Medical device company achieves paperless management of 1300 business critical documents.

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, a manufacturer of oncology assays for the clinical immunodiagnostic market, overcame this problem by implementing a powerful but economical off-the-shelf document management solution with the flexibility to manage and control all of its documents without customization. “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,” said Don Tenney, Manager of Manufacturing for Oncogene Science.

Need to Meet Quality System Requirements

The FDA’s Quality System Requirements for medical device manufacturers helps assure that medical devices are safe and effective for their intended use. These regulations require that various specifications and controls be established for medical devices, and that devices be designed and manufactured within a quality system to meet these specifications. In addition, procedures that address device installation, servicing, market surveillance, corrective actions and customer complaint handling are vital.

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, how the company conducts corrective actions, and so on. In addition, the company must provide traceability for every kit that it ships, including which customers it was shipped to, the lot numbers of raw materials used, operator identification, the specific pieces of equipment used in each stage of kit processing, and the in-process and final testing procedures, acceptance specifications and results.

Manual Document Management Proves Insufficient

The outcome is that the company, with only 20 employees, uses over 1300 different documents., Many of these consist of work records that its employees must follow and fill out during production to track manufacturing procedures, test results, product shipments, etc. Also, all work records must be approved by supervisors or others after they are completed. 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 said. “There is an enormous amount of labor involved in copying documents, filing documents, retrieving documents, routing documents to the person that needs them, and many other tasks. Manual document management is also prone to errors such as losing documents, using outdated versions of documents, assembling documents with pages missing, etc.”

Oncogene Science makes microtiter-plate based enzyme linked immunoassays (ELISA) kits used to measure cancer-related proteins in human blood. In an ELISA assay, an antibody is immobilized onto the surface of a microtiter plate. This antibody is designed to link with a specific cancer protein that is a disease indicator and may or may not be present in an introduced sample from the patient. Sample material is then washed away and the cancer protein, if it is present, remains linked to the antibody on the plate. Next, a second enzyme-linked antibody is added that binds to the captured cancer protein. Subsequently, this antibody:protein:enzyme complex converts an introduced colorless substrate solution to a colored product that can be measured spectrophotometrically. The quantity of the protein in blood can then be determined.

Selecting An Off-the-Shelf Document Management Solution

The company faced a difficult challenge early in its life after it determined that it would not be practical to operate with a manual document management system. Large medical device manufacturers typically hire consultants to develop a custom document management system based on a framework provided by specialized document software providers. This approach has proven effective for many companies but it involves a major consulting effort that can easily cost over a million dollars and take over a year to complete. “This approach did not make sense for a company of our size,” Tenney said.

“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 a minimal investment in installation, verification, and training,” Tenney said. “We also liked the fact that Powerway has been around for a long time, has a very impressive customer list, and is clearly around for the long term.”

Powerway Document Manager provides a secure environment for document authoring, change control, revision history and audit trail for each document. The administrator function within Document Manager controls permissions for individual consumers and producers, as well as search criteria and designation of document file storage locations called binders. Document producers may perform electronic routing of new or revised documents to reviewers for comment or approval before making them current. All stages of change control are captured within Document Manager, including each phase of editing leading to final approval for each document revision. The associated Powerway Desktop, used by all document consumers, provides capabilities that include easy document search tools, review and comment functions, along with document viewing and printing. Only the most current revision of a document is available to consumers. The only major capability lacked by the application in comparison to a customized system is the automated workflow which is developed by consultants at large expense to match manufacturers’ internal business processes.

Configuring and Operating the Paperless Quality System

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. Bayer HealthCare, Oncogene’s corporate parent, has global standard operating procedures so Oncogene’s documents acknowledge and work within these specifications, often by referencing the appropriate corporate documents. 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.

Streamlining the Document Approval Process

Some of the greatest time-savings 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 that 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 documents out for editing and while these documents are checked out they cannot be modified by others. Distribution of documents 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 said. “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 with which documents move through the approval process and a corresponding reduction in the time that our managers have to devote to document approval.”

Supporting Certification Requirements

The document management system has also 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. Powerway’s Document Manager and Desktop provide 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 added.

“For obvious reasons, Quality Systems regulations place the same requirements on both large and small companies,” Tenney concluded. “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 met 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.”