August 2, 1999
Linweld 8/2/99 Significant deviations include, but may not be limited to the following: Failure to maintain a computer system with validated program capabilities for operating a medical gas facility [21 CFR 1-11.68]. Examples include: No testing of the system after installation at the operating site. Operating sites are part of the overall system and lack...
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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

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