elproLOG EVENT- ELPRO BUCHS AG

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	elproLOG EVENT: Event Analysis & Reporting \| Functionality
	Datasheets

Audit Trail for elproLOG Software

Ensuring traceability of parameter changes and user actions is a key aspect for monitoring systems used in regulated environments.

elproLOG EVENT generates a central audit trail for all ELPRO software components (elproLOG MONITOR, elproLOG ANALYZE, ANALYZE QLS, elproLOG CONFIG). All GMP-relevant changes to parameters and user actions are recorded by the software. elproLOG EVENT makes it easy to answer the core question when operating in regulated environments: Who operated what and when?

elproLOG EVENT Functions

	Every entry is stored with information about the event, user, date and time.
	Data is stored in a tamper-proof database.
	elproLOG EVENT supports compliance with FDA 21 CFR Part 11 / GMP / GLP / GAMP 4 and Annex 11.
	elproLOG EVENT includes comprehensive documentation for IQ/OQs.

Event Analysis & Reporting

Data recorded by elproLOG EVENT is displayed in a clearly laid-out table. Data can be filtered to display only events from a specific period or from a certain user.

Functionality

elproLOG EVENT operates completely in the background and ensures gapless traceability. The following example shows how elproLOG EVENT operates:
1.	13 Mar 2008, 14:02 – A laboratory worker is assigned to reconfigure a datalogger. She runs the elproLOG ANALYZE QLS software and performs the steps required: 1. Readout of the datalogger 2. Storage of the recorded data 3. Re-configuration of the datalogger 4. Re-configuration of the alarm levels
2.	14 Mar 2008, 22:15 – Due to a door left open inadvertently, the temperature of a freezer rises above the specified alarm level. The datalogging system issues an alarm.
3.	14 Mar 2008, 22:30 – A laboratory worker closes the freezer and confirms the alarm using elproLOG MONITOR.
3.	14 Mar 2008, 22:51 – The freezer temperature is back to normal.