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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Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.