Prism Plus Consulting and ColumbiaSoft bring document control solutions to Florida’s medical device manufacturers
The combination of regulatory savvy and practical technology equips quality managers with a straightforward approach for FDA compliance.
Portland, Ore. – March 8, 2012 - ColumbiaSoft, a leading developer of document control software, and Florida-based Prism Plus Consulting are working together to bring advanced regulatory compliance solutions to medical device manufacturers.
Mary McCoy, President and CEO of Prism Plus Consulting said, “Our firm is delighted to connect our expertise in regulatory compliance, operations, and quality with the solutions developed by ColumbiaSoft to offer a comprehensive approach for solving regulatory challenges.”
“There’s a natural synergy with the practical application of our document control platform and the acumen Prism Plus Consulting possesses in quality management,” commented ColumbiaSoft Executive Vice President, David Pogue. “Working together, our clients benefit from the best of both technology and expertise.”
Prism Plus Consulting is skilled in helping firms regulated by the FDA (Food and Drug Administration) improve operational efficiencies and meet stringent regulatory requirements. The firm’s strategic execution of compliance programs comes with the benefit of years of experience in information systems and technology, business process management, regulatory compliance and best practices, and project management.
Implementation of compliance programs requires tools to manage and automate document-centric procedures. ColumbiaSoft’s document control solutions built on the Document Locator platform manage documents and regulated processes with automated workflow, approvals, audit logging and more. The system integrates quality procedures such as corrective and preventative action (CAPA), change management, and standard operating procedures (SOP) within Microsoft Windows Explorer and Microsoft Office. This helps ease user adoption by embedding complex procedures within a familiar working environment.
About Prism Plus Consulting
Prism Plus Consulting is an IT services and business consultancy dedicated to helping organizations become more effective, efficient and profitable. We align the company’s goals and objectives to the processes, regulatory requirements, systems and technology and pull it all together with strong project management. We are proud members of the Board of Directors of Tampa Bay Technology Leadership Association (TBTLA), University of Tampa IT Advisory Board, Armed Forces Communication and Electronics’ Association (AFCEA), Florida Medical Manufacturers Consortium (FMMC), Project Management Institute (PMI), and the Association for Information and Image Management (AIIM). Led by CEO and President Mary McCoy, who is ISO 13485 Lead Auditor Certified, Prism Plus Consulting is nationally certified by the Women’s Business Enterprise National Council (WBENC) as a woman-owned and managed business. Learn more at:
About ColumbiaSoft Corporation
ColumbiaSoft is a leading provider of document control solutions that help businesses in regulated industries reduce risk and improve productivity. Information workers use ColumbiaSoft software to manage and share digitized paper and electronic documents, e-mail, faxes, and other electronic files to lower costs, automate business processes, and meet regulatory requirements. As a Microsoft Gold Certified ISV Partner, an Autodesk Authorized Developer, ARX Strategic Partner, and an Adobe Solutions Network partner, the company’s products fully integrate with familiar applications such as Microsoft Windows, Office, Outlook, SharePoint, CoSign, Adobe Acrobat, AutoCAD, and more. ColumbiaSoft is a privately held company based in Portland, Oregon and was founded in 1998. For more information, visit http://www.documentlocator.com.
Marketing Communications Manager, ColumbiaSoft Corporation
President- Prism Plus Consulting
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