Reprint of BIT Journal Software CAPA Article

The pdf at the link provided is a reprint of an article entitled “Understanding CAPA Requirements in a Software Context” authored by Alan Kusinitz, Managing Partner of SoftwareCPR, for the AAMI Biomedical Instrumentation and Technology journal published in the Spring of 2004.

AAMI – AKusinitz CAPA – article 0504

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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