21 CFR Part 11 Electronic Signatures for manual data entry
Support 21 CFR Part 11 regulatory requirements for Electronic Signatures when manually entering data.
Kenji Hashimoto commented
Include functionality to support the pharmaceutical industry electronic record and electronic signature requirements (21 CFR Part 11) when putting manual entry data by PI Manual Logger or PI Manual Logger Web. Forcing of putting Username / Password and users/administrators should be able to see these records correctly.
Carl Van Laer commented
ES is one item; manually entered values should also be audit trailed