FDA Draft Guidance for Electronic Submission Rev 1

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.

This guidance is jointly issued by the Device center as well as Drugs, Biologics, Food, and Veterinary medicine. Some of the considerations may be relevant to creation of valid Part 11 records as pdfs as well although this is not the purpose of this guidance.

View guidance at this link:  http://www.fda.gov/cber/gdlns/elecgenrev1.pdf

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

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