Ditch Your Filing Cabinets, Go Digital: Electronic Document Management for Research
Research is becoming progressively digital, mobile and rapid-paced, making it extremely important to streamline and digitize processes. Managing paper documents for regulated processes or lab protocols takes up space, creates inefficiencies and leaves room for human error. The University of Rochester has a digital documentation solution, called OnBase, which provides a central repository for better management and control of procedures, protocols, and other departmental or regulated documentation.
OnBase is built for groups who would like to decrease their paper based files and increase compliance to regulations – be it to meet Food and Drug Administration regulations, like Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), or Good Laboratory Practices (GLP), or ISO cleanroom standards. This electronic file management system can help teams track and revise standard operating procedures (SOPs), distribute and trace required staff training documentation, ditch old fireproof cabinets for searchable databases, and streamline some of the cumbersome documentation processes.
URMC’s Upstate Stem Cell cGMP Facility recently implemented OnBase to digitize and streamline processes mandated by the Food and Drug Administration (FDA).
“Our facility is FDA-compliant and going paperless. We still work as a team in our documentation review but now it’s within the OnBase Workflow,” said Luisa Caetano-Davies, Ph.D., principal scientist and facility manager of the Upstate Stem Cell cGMP Facility “Document review dates are now difficult to miss, documents are easy to find, and once approved, they cannot be edited. Above all our documentation is easier to manage and is catastrophe-proof.”
Teams can author and edit documents within OnBase or outside of the system, then upload them to OnBase. Once in the system, all documents are secure, allowing only certain users to edit, as defined by a group’s processes. Based on a workflow designed and validated by each user team, OnBase can then distribute the documents to necessary personnel and track actions, like whether those personnel have read and acknowledged the document.
The system also safeguards against accidental use of old documents. If a new version of an existing document is uploaded, old versions are automatically archived and blocked from distribution. OnBase also complies with FDA 21 CFR Part 11 regulations, which defines requirements and control of electronic documents.
The need for this type of an electronic solution was a long time coming, says Sharyl Zaccaglino, director of Research Quality and Compliance at URMC.
“Several years ago, I interviewed groups around the university that operate in a regulated environment to understand their pain points. One thing that nearly every group said they desired was a way to electronically manage their SOPs,” said Zaccaglino. “We’re very excited to have OnBase in place, and expect it will help researchers save time and money, as well as reduce audit findings.”
If you are interested in implementing OnBase for your lab or team, contact Sharyl Zaccaglino or Academic IT. To learn more about the platform, visit OnBase.
Susanne Pritchard Pallo |
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