Pharmaceuticals and Life Science Regulations
Comply with regulatory agencies requirements for electronic communication
U.S. FDA 21 CFR Part 11
This covers the use of Electronic Informed Consent and includes guidance for institutional review boards, investigators, and sponsors.
It clarifies that it is relevant for all forms of electronic media, and Q15 covers the archiving of information.
Q3 clarifies that the consent process “…may be accomplished by in-person discussions with study personnel or
through a combination of electronic messaging, telephone calls, video conferencing, or a live
chat with a remotely located investigator or study personnel”
Read the full guidance here
EU Pharmaceutical Legislation (EUDRALEX Annex 11)
The EudraLex covers rules governing medicinal products in the European Union.
Volume 4, Annex 11 covers Computerised Systems, good manufacturing practices while producing medicinal products for human and veterinary use.
Subsection 17 covers archiving of data that includes communication.
(This is the European equivalent of the FDA 21 CFR Part 11).
Read the full requirements here