Day

April 16, 1996
Cobe 4/16/96 Hemodialysis 10. Failure to have adequate checks designed and implemented to prevent inaccurate data output, input, and programming errors when automated data processing is used for manufacturing or quality assurance purposes, as required by 21 CFR 820.195. For example, the computer search process for complaints by serial number is not designed to detect...
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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

Email office@softwarecpr.com
for more info!

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.