Workshop - IT support

Aims

Photo from Leuven workshop on IT support

The aims of the workshop are threefold. Firstly, let participants discover what is on the market for supporting their quality management system.

Secondly, through presentations and by practice and discussion, to define more precisely which criteria are important to them for implementing in a software package.

And thirdly, to better understand possible ways of organizing quality systems, independent of particular software solutions.

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15/16-09-2005 Leuven

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Report on workshop on IT support for quality management - Leuven

a. Focus and approach

Based on feedback from the first workshop, the decision was made to address software packages to support quality management systems. The successful format of mixing lectures and interactive sessions was maintained.

A quality management system should at least include document control, auditing, training of personnel, follow-up of corrective and preventive actions, maintenance and calibration of equipment and reagent and batch control (figure 1). All these aspects can be included in a software package, to optimally support the quality system. Laboratory Information Management Systems (LIMS), which only include tracking and monitoring of laboratory data, were not included in the scope of the workshop.

FIGURE 1 - ASPECTS OF A QUALITY MANAGEMENT SYSTEM

During the first part of the workshop, three companies presented their software solutions. Afterwards, all participants had the chance to work hands-on with the software, alternating with brief question-and-answer sessions. On day two, further time was available for working with the software, and presentations were given by three further companies. To exchange and analyse experiences best, a full group debate was held, after individual analysis and sub-group 's. A number of advantages and disadvantages of implementing a software package became clear, and a group consensus was reached for a list of criteria for selecting a software system. A significant finding and a subject of animated ', were the relative advantages of managing the QMS in a databasecentred or a document-centred fashion. The conclusion was essentially that both approaches can work and the choice is a matter of preference.

b. Outcome

A thorough internet search ^e was performed to identify QMS software on the market. EuroGentest has no intention to sell or to give preference to any package, and consequently the list in box 4 is only a random selection and could be a starting-point in the selection of a proper software programme that fits a particular laboratory's workflow. It will help to give an idea what IT support could include, or rather what the different approaches and possibilities are to support a quality management system. The software companies marked, contributed to the workshop either by a presentation alone (*) or by a presentation and providing installed demo versions (**), permitting the participants to evaluate and test the software. These companies were also asked to provide details of the different modules in their software, the technical requirements, the possibility to link with other programmes (e.g. hospital information systems), support, maintenance, training and prices. This comparison revealed huge differences between the available software solutions.

BOX 4 - QMS SOFTWARE SYSTEMS IDENTIFIED BY INTERNET SEARCHING
(this list is provided 'as is' - EuroGentest does not sell or give preference to any package)

Amadeus Solutions - eQRP (France)	Master - ControlIntegrated Quality Suite (US)
http://www.amadeussolutions.com/	http://www.mastercontrol.com/
Autoscribe - Matrix LIMS (UK)	Noweco - JKT9000 (Germany)
http://www.autoscribe.co.uk/	http://www.noweco.com/
Bitos - Mithras (Belgium) **	Pilgrim Software - SmartSolve (The Netherlands) *
http://www.bitos.com/	http://www.pilgrimsoftware.com/
bizzApps - Quality Manager (The Netherlands)	PQ Systems - Quality Workbench Professional (UK)
http://www.bizzapps.com/	http://www.pqsystems.com/
Gael Quality - Q-Pulse (UK) **	Quality On-Line - Quality On-Line (The Netherlands)
http://www.gaelquality.com/	http://www.qualityonline.com/
Genial Genetic Solutions - iPassport (UK) **	Qualsys - EQMS (UK) *
http://www.genialgenetics.com/	http://www.qualsys.co.uk/
Interax Group - Paradigm II (US)	SoftTech Health - SoftTech Lab QMS (US)
http://www.interaxgrp.com/	http://www.softtechhealth.com/
LabWare - LabWare LIMS (UK)	Software Compliance - ISOXPERT (US)
http://www.labware.com/	http://www.softwarecompliance.com/
Lysoft - Quallys laboratoire (Switzerland) *	Sparta Systems - TrackWise (Israel)
http://www.quallys.ch/	http://www.sparta-systems.com/

The test sessions on the computers were focused with concrete questions, exercises and road maps developed by EuroGentest and the companies. Through the exercises and the 's, participants developed their understanding of the different elements of a quality system, for example document control (see figure 2, based on David Burnett, A practical guide to accreditation in laboratory medicine, p71-72 1 ). So participants not only had an overview of how IT can support their QMS, but were also introduced to different ways of organizing quality systems.

FIGURE 2 - DOCUMENTATION CONTROL

STEP 1 PREPARATION
Registration of a new document as a draft document.
It is a requirement that documents are uniquely identified.

STEP 2 AUTHORIZATION OR APPROVAL
The document moves from a draft to being an active document. The responsibility for authorization is normally that of the person in a direct line management relationship.

STEP 3 ISSUE AND DISTRIBUTION
Date of issue should be added.
Version (edition) number should be added.
Distinguish between the circulation of authorized and unauthorized copies.

STEP 4 REVIEW
Reviewing a document is to ascertain its continuing ‘fitness for purpose’.

STEP 5 REVISION
When major changes come to light, the document can be revised and a new version issued.

The motivation to change to a software-based quality management system could include issues like saving time due to reduced paperwork, better traceability, simplified follow-up of audits and corrective actions, and programmable notifications. Furthermore, a central data store, accessible from everywhere, makes work more efficient and well-organized. On the other hand, besides the initial cost, it will take significant time and effort to implement the system and to win everybody over to its advantages.

A necessary starting point when selecting a system is compiling a requirements list of what is needed to fit with the own laboratory workflow. Define what is essential for your laboratory, based on what you have already in place, the size of the laboratory, IT experience, long-term expectations and existing data. During the workshop, such a list of criteria was drawn up during group 's (see box 5), which can provide a starting point or guidance for each laboratory.

BOX 5 - CRITERIA WHICH SHOULD BE TAKEN INTO ACCOUNT WHEN SELECTING A SYSTEM

User-friendly	Familiar interface Restricted access so that only relevant information is shown Intuitive and simple Logical structure Multiple languages possible Designed for laboratories . results recording from routine EQA It has to appeal to the lowest common denominator Easy to implement all the data you already have Does it require exclusive training of all staff?
Complete	Follow up of documents, audits, non-conformities, corrective and preventive actions, complaints, training, equipment, reagents, suppliers � Extra: statistic information, printing possibilities of labels, graphics Make a combination of modules and buy extra modules when laboratory is ready for it. Customization, a flexible system built for purpose Co-develop a system (expensive! / maintenance?) The system should fit with the laboratory requirements and integrate with the current processes, databases etc.
Support	All aspects: product updates, new versions, maintenance Populate it with all the data Helpful/efficient after sales service Confidentiality (confidence that the company will be there in 5 years) Support from local IT-department involve from the beginning Support from people in your own laboratory with a strong training or experience User groups of people using the same software afterwards coming to the company to try to implement it consensus in the group Customer forums: feedback, questions
Costs	Especially for small laboratories Initial costs + hidden costs (new hardware, training, update, manual, extra license?) Long-term cost: what if new requirements emerge?
Systems	Database-based (database centric): advice for the future Document-based (index centric): ok for small laboratories Is the system validated? Robust and reliable Possibility to link with other existing

e Using combinations of the following key words: compliance, quality, management, software, ISO, laboratory, audit, document control

c. Discussion

During the 's it became clear that everybody was strongly in favour of implementing a software package to support their quality system. Some barriers were identified, including convincing the management, or extra workload and costs; suggestions were formulated to overcome these problems.

The principles of managing change processes can be applied. Start by involving all relevant people from the beginning, including technicians, secretaries and the IT personnel, as well as the quality manager and laboratory director. Listen to their ideas and distribute responsibilities to increase motivation. When people have the impression that they contribute to the decision-making, they will be more open to implement and to put effort into the new system.

Take your time to educate yourself via colleagues, internet and demo versions. Visiting a laboratory that uses a system could help convince personnel of the value of changing. To reduce the excess workload, invest in training and work in a phase-to-phase approach, implementing and optimizing one module before you start implementing others; to reduce or spread the costs, purchasing of modules can be phased.

General consensus was reached on criteria which should be taken into consideration before choosing a software system. When comparing currently available software with these criteria, it was evident that all packages had interesting aspects, but that none yet really fulfilled all the ideal criteria for quality management in genetics laboratories.

Based on the feedback afterwards, it was clear that every participant took something out of this workshop, despite the difference in experience with software packages. Existing users had the opportunity to discover which features their software has (or not), in comparison with other packages; new ideas were obtained for optimizing their own system. Non-users became aware of the usefulness of software for their QMS, and now have an idea how to choose and implement a system.

In addition to the benefit for participants, the companies present - who could participate freely in all sessions - collected information and feedback. They were able to talk to users or potential clients and hear their concerns and wishes. Based on the criticism and comments they received, promising new versions were released by Gael Quality and Genial Genetics Solutions.

Some of the participants are now in the process of selecting a system; some have already acquired a software package that was shown at the workshop. EuroGentest Unit

(The whole report can be downloaded in html or pdf Download PDF Document .)

D. Burnett. A practical guide to accreditation in laboratory medicine, (ACB Venture Publications, 2002).
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Last changed: 2008-02-06

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