Date Stamping for Electronic signatures

[madannc]

In an open system such as web access, should the date stamping be local time e.g. the date and time the action was performed in the local country or should the date and time stamp be the same as the server that holds the software as in a closed system.

thx Nigel

[Gert Sorensen]

If the system is located on a server, then you should use the servers time stamp. Local time can be altered by the user, and it poses a risk of invalidating your data entry.

[madannc]

thats what I thought but wanted to make sure

thx Nigel

[Ajit Basrur]

Agree with Gert.

As per 21 CFR Part 11, section 11.30 for open systems, http://www.accessdata.fda.gov/script...h.cfm?fr=11.30

Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.