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gpsv
Some thoughts on Requirements … using the General Principles of Software Validation to help. Many times we struggle with creating software requirements and documenting them.  The FDA General Principles of Software Validation-Final Guidance helps set the FDA expectations in this area.  Section 4.1 of the guidance states: “A documented software requirements specification provides a baseline for both...
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/Docs/SCPRed/NEBDGPresentationSlides022802GPSV-SW68-Kusinitz.PDF
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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:

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  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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