FDA ORA Software Glossary

FDA’ s Office of Regulatory Affairs “GLOSSARY 1 OF COMPUTERIZED SYSTEM AND SOFTWARE DEVELOPMENT TERMINOLOGY” issued in August 1995. This glossary contains definitions for many software engineering and validation terms. In most cases these definitions are taken from external standards organizations. CDRH references this glossary from several guidance documents.

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.