elproLOG ANALYZE QLS - ELPRO BUCHS AG

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	elproLOG ANALYZE QLS: Audit Trail \| System Requirements \| Complete Qualification Documentation
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A personal logon is performed at software startup.

Software package for qualified Systems

elproLOG ANALYZE QLS is the software package for qualified systems. This software helps you comply with the provisions of FDA 21 CFR Part 11, GMP, GAMP4, GLP and Annex 11. The detailed validation manual contains IQ/OQ templates for easy software qualification.

elproLOG ANALYZE QLS includes all ANALYZE software functions and implements numerous important tools to facilitate your work in qualified environments. For ELPRO, as for many of our customers, safety and traceability in processes are central issues. Consequently, all ELPRO development complies with GMP specifications. This guarantees the quality and security you expect.

Security for validated environments

	Software validation with ELPRO validation manual for 21 CFR Part 820
	Forgery and manipulation protection – coded data transfer from logger to PC
	Multipath transmission with check sums
	Compact coded data file
	Compliance with FDA 21 CFR Part 11
	Automatic audit trail created at data readout

All activities related to measured data are recorded in an audit trail.

Audit Trail

An audit trail is created automatically during data readout from the datalogger. All data-relevant transactions are recorded. Each file generated in this manner is an individual and completely safe document. The raw data (source file) cannot be manipulated. The audit trail is attached to the file that contains the measured values. The resulting electronic document has the advantage of being a completely independent record that can easily be e-mailed or printed at any time.

Advantages of an audit trail solution

	All requirements for electronic documents are in compliance with FDA 21 CFR Part 11.
	You can send the files from any PC.
	Security: The elproLOG ANALYZE QLS software is required to open the generated data files. For this reason, the audit trail function guarantees a complete data security solution.
	Clear, understandable audit trail documents all previous modifications.
	Audit trail cannot be removed from the source file (*.mdf).

System Requirements

	Operating system: Windows 2000, Windows XP, Windows Vista *
	PC requirements: Pentium 1.5 GHz
	Memory: 512 MB RAM
	Free memory on HD: 50 MB
	Screen resolution: Min. 800x600 pixels
	Interface: RS232, USB or LAN

* Windows® is a registered trademark of Microsoft Corporation in the United States and other countries.

Qualification documentation for elproLOG
ANALYZE QLS

Complete Qualification Documentation

elproLOG ANALYZE QLS is not just the result of many years of industryoriented software development; it‘s a complete qualification solution. In combination with the software package, you receive a complete set of qualification documentation that passes on our know-how in the form of guidelines and templates for your qualification process. We take you step by step through the individual stages of the qualification process, saving you time and money.

Software installation: elproLOG ANALYZE and ANALYZE QLS software can be implemented as a stand-alone application or as a network-based solution. It is installed locally on each computer, either from a CD or via the network. Running the software directly from the CD or network drive without performing an installation is not possible. An additional licence is required for each QLS version installation. It is possible to define a working directory for access to shared data.

Qualification Documents - Summary

With elproLOG ANALYZE QLS, you receive two binders of valuable qualification documents for your ELPRO datalogging system.

How to use
Our goal is to make the qualification work as easy and smooth as possible for you. Therefore, we included detailed checklists that guide you step by step through the qualification procedure.

Vendor Software Quality
The ELPRO QLS Workbook includes important information about the GMP-compliant product development process at ELPRO. It also includes a declaration of compliance to FDA 21 CFR Part 11 and a copy of our company‘s ISO 9001 certificate.

Installation Qualification
The Installation Qualification (IQ) templates in the workbook ensure easy step-by-step qualification. For additional assistance, we included a complete IQ, referred to as vendor qualification, on yellow pages in the workbook.

Operation Qualification
During the Operation Qualification (OQ) all relevant functions of the elproLOG ANALYZE QLS software are tested, from data read-out to report generation. All qualification steps are listed in clearly laid-out forms to to help you perform the qualification. And to simplify your work, we included a complete ELPRO vendor qualification.