White Paper for 21CFR 11-Compliance D-SE-3207Eh, March 2005 elproLOG
Test Plan for all ELPRO Data Logger Systems using PC Evaluation Software elproLOG 3.3x - QLS
Conclusions:
Client Responsibilities
Tested and validated are all relevant points of the elproLOG PC software regarding 21 CFR Part 11.
Additional client responsibilities are indicated in the document. Main points to be considered by the user are:
- PC and operating system security
- Operating System Access rights
- IQ / OQ procedure
The evaluation software for dataloggers elproLOG V 3.3x QLS is fully compliant to the requirements of 21CFR11.
This evaluation software elproLOG can be used for the evaluation and documentation of the complete range of elpro dataloggers

[...]

Alle weiteren Informationen erhalten Sie in diesem Dokument (Download PDF-Datei)

[Startseite der Datenbank]	[zurück zur letzten Seite]	[Artikel als Email verschicken]

Diese Seite drucken