FDA CDER/CBER Electronic Labeling Guidance

The Center for Biologics and the Center for Drugs has issued a final guidance for the submission of labeling in electronic form for FDA review. (Note: it does not pertain to electronic labeling provided to users).

SoftwareCPR keywords: Blood Bank, electronic submission, online submission

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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15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.