FDA SOPP 8116 Electronic Signatures

FDA Center for Biologics Evaluation and Research released SOPP 8116 “Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff” Version #4

Effective Date: August 10, 2010. This describes their approach to using electronic signatures for certain regulatory approvals (including correspondence and premarket submissions) and is based on applying each person’s network profile identification via the Adobe Electronic Signature Process. More information is at this link:  http://1.usa.gov/1bAnodB

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.