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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.”
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