April 30, 2015
Soft Computer Consultants, Inc.Product: Class I/II software systems Date: 4/30/2015 1. Failure to adequately establish procedures for CAPA as required by 21 CFR 820.100(a). Specifically, A. Product Change Controls (PCCs) which are corrective and preventive actions for handling software coding defects do not always include investigating the cause of all nonconformities relating to product, processes...
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Hospira Lifecare PCA infusion pump running “SW ver 412” does not require authentication for Telnet sessions, which allows remote attackers to gain root privileges via TCP port 23.  The U.S. Department of Homeland Security has been working with Hospira to get this resolved and Hospira will be performing a recall to correct this.
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Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
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