E- xmatch FDA Reviewer Checklist

FDA CBER “Computer Cross match reviewers checklist”. We’re not sure of the date of issue of this checklist. It is intended for use by FDA reviewers reviewing blood establishment Blood Bank applications for approval to use electronic cross matching. of primary used to reviewers and to blood establishments it provides blood bank Computer System manufacturers insight into what their customers must provide to obtain approval to use the electronic cross matching features oficomputer systems.

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!

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