SI20-058

Service Information
e-signatures time stamp of visionCATS
May 2021/SI20-058/UB 1 page

Purpose The purpose of this SI is to inform and confirm the behaviour of visionCATS for
the e-signature time stamp.

Issue There are two different time stamps for the e-signature printed in the report.

Log information for e-signature in visionCATS (shown for version 3.1, valid for version up to 3.1)

Information
The first time stamp (in the example above 09:50:42) is referring to the local
time of the server PC of the system where the signature process has been
executed.
The second time stamp (in the example above 07:50:42Z) is referring to the
Coordinated Universal Time (UTC or Z for Zulu-time) of the system where the
signature process has been executed.

Both times are set in the PC settings (PC time and time zone).
The accuracy and correctness of the PC time has to be controlled and is in the
responsibility of the customer.
Conclusion
The time difference is due to the fact that we have to show (on the report) an
undisputable time for the e-signature. The Z behind the time in the report is
indicating Zulu time (more information under
http://wwp.greenwichmeantime.com/info/zulu ).

This behaviour is seen as fully in line with the requirements of FDAs 21 CFR Part
11 and EudraLex Annex 11.

For CAMAG

Ueli Bloesch
Head Service & Repair

support@camag.com