HIMA 1998 Software Validation Talk Transcript

Alan Kusinitz, Managing Partner of SoftwareCPR, chaired the Production Software Validation sessions of the 1998 HIMA Software Conference. The attached pdf file is a transcript of his talk “Validating Manufacturing Process Software: Regulatory Issues” and a transcript of the Q&A session for all of the talks on this topic. During the Q&A there is some informative discussion with Steward Crumpler of FDA on several issues including validation of compilers.

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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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