Day

October 25, 2003
Guidance for Industry and FDA Staff Providing Regulatory Submissions in Electronic Format — General Considerations.  Document dated Oct 22, 2003. This guidance focuses on use of pdf files. It provides many specific requests in construction of the pdf for suitability for electronic submissions. These include resolutions, pagination, preference for digital instead of scanned source documents....
Read More

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!

Corporate Office

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