elproLOG QLS qualified Software according to FDA 21 CFR Part 11

D | E | F

PC evaluation software for qualified systems

elproLOG QLS: Specifications | Audit Trail | Personalization | Example Audit Trail + Action Log

One software - one validation - for 38 different dataloggers.

made to comply to:
GAMP, GLP, GMP
21 CFR Part 11
21 CFR Part 58
21 CFR Part 210
21 CFR Part 820
with IQ / OQ Documentation

Security features:

	Software validation in accordance with ELPRO validation manual for 21 CFR 820
	Forgery and manipulation protection
	Coded logger to PC data communication
	Multipath transmission with check sums
	Compact coded data file
	Logger programming protection possible with pin code
	Complies to 21 CFR Part 11, Electronic Records

elproLOG QLS is the extended version of the elproLOG standard software. In addition to the standard functions, elproLOG QLS has an audit trail function and an extended qualification manual for qualification and validation of pharma and medicine systems.

You will find all the information about the standard software in the elproLOG QLS at Software standard.

elproLOG Software QLS	Part Nr: 2339-BL base license
	Part Nr: 2339-FL additional license

	Single place version (local or server)
	Languages: ENG, GER, FRE, (ESP), (ITA)
	Windows NT, Windows 2000 and Windows XP
	Audit trail in all MDF files (for 21CFR11)
	Documentation for IQ / OQ and for software validation (with basic license only)

QLS Manual for qualification and validation.

Qualification and validation with the elproLOG QLS audit trail

ELPRO dataloggers are sent to destinations all over the world. This requires that .MDF data files be mobile. For this reason, audit trail is created automatically during datalogger readout and is attached to the file which contains the measured values.The elproLOG software files are not based on a database system. Each file is an individual, completely safe document. It is not possible to manipulate the raw data in the files. The complete MDF data files is protected by a checksum.

The advantages of an audit trail solution are:
	All requirements for electronic documents met.
	The user can send the files from any destination.
	Security: the elproLOG QLS program is required to make changes to MDF files and is required by other persons who want to work on the files. For this reason, audit trail offers a complete security solution.
	Comprehensible audit trail for documentation of all previous modifications.
	Audit trail can not be removed from the MDF file.

Audit trail consists of a time-stamp to record all entries and actions: create, convert, save as, save configuration, modify or delete information in the MDF record. It can be displayed on the screen and an overview can be printed in a paper form.

Datenlogger elproLOG QLS Software Screen

Start Screen QLS.

Personalization in start-up window due to audit trail entries

Computer name:
	From operating system generated system name
	Can not by altered when starting elproLOG
User name (system):
	From operating system generated by user log-in (access rights by user name and user password)
	Can not by altered when starting elproLOG
User name (custom):
	Optional clear-text user name for easier identification of the user, as system user names often use ambiguous abbreviations or even numbers
	This option is not a CFR requirement, as the authorized user access and verification is realised by the operation system
	It is recommended to use the full name of the user for confirmation purposes

Example QLS Audit Trail + Action Log