quality management system vendor software system use benchmark march2014

OVERVIEW The purpose of this survey was to collect data from companies on enabling technology currently

used to support key areas of their Quality Management System.

Data was collected from the LinkedIn Quality & Regulatory Network group representing over 77,000

professionals worldwide. Over 620 members from multiple industries participated.

Key Findings:

• Although many enabling technologies are available for both small and global companies, the

majority of organizations still use manual methods to track and manage their Quality

Management System.

• Many participants commented on the both the benefits of an electronic system and platform and

also the challenge on configuring and sustaining quality software especially globally.

Listing of all Software Vendors mentioned by participants in this survey can be found in the

Appendix.

Any questions about this Survey can be sent to Nikki Willett, Founder/Owner LinkedIn Quality &

Regulatory Network.

2 Q U A L I T Y & R E G U L A T O R Y N E T W O R K C o p y r i g h t 2 0 1 4 Q u a l i t y & R e g u l a t o r y N e t w o r k

*Source Data: LinkedIn Quality & Regulatory Network Group, March 2014

LinkedIn, the LinkedIn logo, the IN logo and InMail are registered trademarks or trademarks of

LinkedIn Corporation and its affiliates in the United States and/or other countries. All other

references to company and product names are copyright in their own right.

Copyright 2014 . Quality & Regulatory Network by Nikki Willett. All rights reserved.

mailto:[email protected]?subject=QMS Software Vendor Survey

http://www.linkedin.com/groups?home=&gid=80327&trk=anet_ug_hm

http://www.linkedin.com/groups?home=&gid=80327&trk=anet_ug_hm

DEMOGRAPHICS REPRESENTATION FROM PARTICIPANTS ABOUT THEIR INDUSTRY


3.9% 1.0%

9.3%

1.3% 1.0%

4.3% 1.6% 1.0%

4.2% 3.2%

9.0%

2.4%

21.5%

1.0%

29.1%

1.6%

5.0%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

Note: Some answers were consolidated under one industry while those with only a single response were allocated to "Other."


DEMOGRAPHICS REPRESENTATION FROM PARTICIPANTS ABOUT THEIR COMPANY ANNUAL REVENUE

AND THEIR ROLE OR FUNCTION WITHIN THE COMPANY


9.0% 3.7%

60.4%

10.0%

1.0% 3.9%

1.3% 2.6% 0.8%

7.5%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

less than 25M 33%

26-500M 28%

500-999M 12%

more than 1B

27%

Annual Revenue Role / Function


INTERNAL/EXTERNAL AUDIT

5

Note: Some participants may have selected multiple systems if represented within their organizations.

Those software vendors with less than a 1% response are not reflected in the chart but are included in

the list of other Vendors.


Q U A L I T Y & R E G U L A T O R Y N E T W O R K C o p y r i g h t 2 0 1 4 Q u a l i t y & R e g u l a t o r y N e t w o r k

50.1%

3.4% 3.8% 1.3%

4.1% 2.7% 1.4% 3.6%

1.3% 4.9%

1.4%

9.7%

0.7%

11.5%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

Ma

nu

al

Cu

sto

m D

eve

lop

ed

ET

Q

Info

teh

na

Qu

alit

y E

xp

ert

Ma

ste

rCo

ntr

ol /

QA

AD

Ora

cle

Pilg

rim

So

ftw

are

Q-P

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e

Qu

ma

s

SA

P

Sh

are

Po

int

Tra

ckw

ise

(S

pa

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Syste

ms)

Tra

ctio

n T

ea

mp

ag

e

Oth

er

OTHERS:

123Compliance Lotus Notes

Arena PLM MetricStream

AssurX CatsWeb Microsoft Navision

Audit Utopia Montrium Connect

Bespoke Neomatics ExpressPack Quality

BLUe-CAT Synergy NextDocs

BSI Entropy Omnify Empower

Cama Software Optiva (Infor)

CIQA QA Manager Pastel

CloudForge Prodom (I.A.C.T.)

CloudQMS Q5 Systems

ComplianceControl Centre QAD

DNV.GL Synergi Qasys Software (Umbani)

Documentum QPR

eMatrix Quality Online (Icologiq)

Ensur Mystic Quality Works

Entropy (BSI) Qualtrax

Harrington Group

International Rivo Safeguard

HP Quality Center Salesforce

IBS ServiceNow

Ideagen Workbench SoftExpert Excellence Suite

IHS SoftTech QMS

InfoRouter Solabs

Intelex Stemsoft

Intertek Sword Achiever

ION Simple Trak TipQA

IQS Veeva

Jira (Atlassian) Vivaldi Software

LabExpert WQS

CAPA

6






40.7%

2.4% 1.1%

3.6% 1.5%

3.4% 2.6% 3.2% 2.4% 3.2% 1.1%

4.5%

1.1%

12.8%

1.1%

15.1%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

45.0%

Ma

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lop

ed

Assu

rX C

AT

SW

eb

ET

Q

Info

teh

na

Ma

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oft

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Da

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ult,

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Tra

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(S

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Tra

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ea

mp

ag

e

Oth

er

OTHERS:

123Compliance NovaTek

BLUe-CAT Synergy Process Pro

Bugzilla Prodom

Cama Software Q5

Cebos Qasys

CIQA QA Manager QPR

CloudForge QSTAT

CloudQMS Quads

CloudQMS Quality Online Icologiq

ComplianceControl Centre Quality-Works

Compliancewire Qualtrax

Documentum QuickControl

Ensur QUIPS

Entropy Redmine

Grand Avenue Rivo Safeguard

HP Quality Center ServiceNow

IBS Simple Trak

Ideagen Workbench Soft Expert

Intelex SoftTech QMS

Intertek SOLABS QM

IQS STEMSOFT

JIRA Sword Achiever

Job Boss The QAB

Lotus Notes TipQA

MetricStream Title21

Montrium Connect Veeva

Neomatics Vivaldi Software

NextDocs

CHANGE CONTROL

7






40.7%

2.6% 1.1% 2.0% 1.3%

3.3% 2.2% 2.0%

6.7% 3.2%

1.3% 3.2%

1.1%

13.9%

1.1%

14.9%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

45.0%M

an

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Do

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Sie

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ise

(S

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Tra

ctio

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ea

mp

ag

e

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OTHERS:

123Compliance LabExpert

AssurX CATSWeb Lotus Notes

Audit Weaver MetricStream

BLUe-CAT Synergy Micros Inspire

Bugzilla Montrium Connect

Cama Software Neomatics

CIQA QA Manager NextDocs

CloudForge NovaTek

CloudQMS PDXpert

ComplianceControl Centre Process Pro

Ensur Prodom

Entropy Q5

e-Packmat Qasys

Grand Avenue Quads

Harrington Group

International Quality Online

IBM Rational Change Qualtrax

IBS QuickControl

Ideagen-Workbench SoftExpert Excellence Suite

IHS Solabs

Intelex STEMSOFT

IQS Sword Achiever

ITSM TipQA

JD Edwards Title21

JIRA Veeva

Kintana Vivaldi Software

Lab Vantage ZenDoc

COMPLAINTS






53.9%

4.7% 4.7% 1.9%

4.7% 3.3% 1.4% 5.8%

1.9% 4.4%

1.1% 4.1%

10.2%

1.4% 1.7%

19.6%

25.7%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%M

an

ua

l

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eve

lop

ed

ET

Q

Info

teh

na

Ma

ste

rCo

ntr

ol

Ora

cle

Arg

us

Ora

cle

Sie

be

l

Pilg

rim

So

ftw

are

PL

M (

Ag

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Are

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Q-P

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Sa

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orc

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SA

P

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Tra

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ea

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ag

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Tra

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(S

pa

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ms)

Oth

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OTHERS:

123Compliance JIRA

ARISg Lotus Notes

AssurX CATSWeb MetricStream

Beacon Microsoft CRM

Bespoke systems Microsoft Dynamics

BLUe-CAT Synergy Montrium Connect

Breeze Neomatics

Bugzilla NetRegulus

CALLS (Volos) NorthStar

Cama Software Optiva

CIQA QA Manager PQMS

CIS Prodom

CloudForge Q5

CloudQMS Qasys

ComplianceControl Centre Quads

CTQ Quality Online

CTS Quality-Works

Documentum Qualtrax

Donor Dialogue's DRM

Touch QuickControl

Ensur Sage

Entropy SCEPTRE

ePowerCenter

SE SUITE -

SOFTEXPERT

EthicsPoint ServiceNow

Grand Avenue Simple Trak

Harrington Group

International SoftTech QMS

IBS Sunquest

Ideagen Workbench Sword Achiever

Infor TIP QA

Intelex Vivaldi Software

IQMS WMS

IQS WQS

DOCUMENT MANAGEMENT






50.8%

2.5%

13.6%

1.4% 5.6% 4.5%

2.0% 1.4%

10.2%

3.7% 2.8% 3.7% 8.5%

5.1% 4.2% 5.1%

23.2%

1.4% 1.7%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

Ma

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Do

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me

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m

En

su

r

ET

Q

Fir

stD

oc

Info

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Lo

tus N

ote

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Ma

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ocs

Op

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Te

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Pilg

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So

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Ag

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Qu

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Tra

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ag

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Ve

eva

OTHERS:

AssurX CATSWeb Montrium Connect

Audit Weaver Neomatics

BLUe-CAT Synergy NovaTek

BPLM Oracle Contract Manager

Cama PDXpert

CIQA PMED

CloudForge PONDUS

CloudQMS Prodom

ComplianceControl

Centre Product Vision

DCS Qasys

Docspace QSi

eDocs Quality Online

eMatrix Quality-Works

Entropy Qualtrax

Epiware Regula

Grand Avenue SE SUITE - SOFTEXPERT

HP Quality Center Simple Trak

HQMS SoftTech QMS

IBM FileNet Solabs

Ideagen Workbench STEMSOFT

Intelex Sword Achiever

IQS The QAB

JIRA TIP QA

Knowledge Tree Title21

LabExpert TRIM

Liquent Vivaldi software

LiveDrive Xerox

MetricStream ZenDoc

EXCEPTIONS (DEVIATIONS, EVENTS, NONCONFORMANCES, OUT OF SPEC/TOLERANCE/TREND)






62.8%

2.9% 1.1% 2.9% 1.6% 1.1% 5.6%

1.3% 1.1% 1.9% 4.3% 4.5% 4.3% 1.6%

8.8%

20.3%

1.1%

18.7%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

Ma

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lop

ed

Ca

ma

So

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are

ET

Q

Info

teh

na

Lo

tus N

ote

s

Ma

ste

rCo

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ol

ME

S (

Ca

msta

r, E

pic

or,

Ro

ckw

ell,

Sie

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SA

P,…

Me

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Str

ea

m

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Pilg

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So

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PT

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Q-P

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Qu

ma

s

SA

P

Tra

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ise

(S

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ms)

Tra

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ea

mP

ag

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OTHERS:

123Compliance Neomatics

AssurX CATSWeb NextDocs

Blue Mountain NovaTek

BLUe-CAT Synergy Prodom

CIQA QA Manager Qasys

CloudForge Quads

CloudQMS Quality Online

Compliance 360 Quality-Works

ComplianceControl Centre Qualtrax


eDocs Rivo Safeguard

eMatrix SE SUITE - SOFTEXPERT

Ensur ServiceNow

Entropy SharePoint

Epiware Simple Trak

Grand Avenue SoftTech QMS

IHS STEMSOFT

Intelex Sword Achiever

IQS Synergi

JIRA TIP QA

Kintana Title21

Montrium Connect Vivaldi Software

LABORATORY MANAGEMENT




Multiple lab products provided by a Vendor were consolidated under the Vendor's name. Those

software vendors with less than a 1% response are not reflected in the chart but are included in the list

of other Vendors.

69.0%

2.4% 1.7% 5.4%

1.4% 4.4%

17.7%

5.1% 8.2% 6.1%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%M

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Acce

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La

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La

bV

an

tag

e

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bW

are

Sta

rLM

S

Th

erm

o S

cie

ntific

Oth

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OTHERS:

ApolloLIMS

Blaze LIMS

FoxPro

Lims1

Maximo

Northwest Analytics

Oracle Harvest

SAP

SLIM (InterCAX)

SQL*LIMS

UniLab (Siemens)

ZuMatrix

TRAINING






63.3%

4.1% 1.2% 1.5%

7.0%

1.2% 2.1% 2.1% 1.8% 1.2% 5.0% 5.9% 4.1% 3.2% 3.8% 1.8% 2.1%

10.3%

2.1% 1.2% 1.2% 4.4%

23.2%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

Ma

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Ca

ma

So

ftw

are

Co

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rsto

ne

Co

mp

lian

ce

wir

e (

UL

Ed

un

ee

rin

g)

En

su

r

ET

Q

eT

rain

info

Info

teh

na

IQS

Iso

Tra

in

Ma

ste

rCo

ntr

ol

Ora

cle

(P

eo

ple

so

ft,

Le

arn

.co

m,

etc

.)

Pilg

rim

So

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Q-P

uls

e

Qu

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Sa

ba

SA

P (

Su

cce

ssF

acto

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Pla

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etc

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Su

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ota

l

Tra

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mP

ag

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Tra

in T

rack (

Ha

log

en

)

Tra

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ise

(S

pa

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ms) O

the

r

TRAINING (VENDORS LIST)

Q U A L I T Y & R E G U L A T O R Y N E T W O R K C o p y r i g h t 2 0 1 4 Q u a l i t y & R e g u l a t o r y N e t w o r k 13

OTHERS:

AssurX CATSWeb Entropy Noverant Taleo

Axentis (Omnicare) FoxPro OCS TEDS

CAP Software Grand Avenue Pilgrim TIP QA

Cebos Harrington Group International PLM (Agile, Omnify) Title21

CIQA HealthStream Quality Online Uperform

CloudForge iLearning (Seertech) Qualtrax Veeva

CloudQMS Intelex SE SUITE - SOFTEXPERT Vivaldi Software

Compliance 360 Learning Plus SharePoint WindFarmManager

ComplianceControl Centre MetricStream Simple Trak Workday

Dokeos Montrium Connect Smart HR ZenDoc

eMatrix NextDocs Solabs

Engage (HR Software) NovaTek Sword Achiever





SUPPLIER QUALITY






69.4%

2.3% 2.9% 1.6% 3.6% 2.6% 2.1% 3.6% 1.3% 1.8%

15.3%

1.3% 1.0%

10.6%

20.0%

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

Ma

nu

al

Cu

sto

m D

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ed

ET

Q

Info

teh

na

Ma

ste

rCo

ntr

ol

Ora

cle

Pilg

rim

So

ftw

are

Q-P

uls

e

Qu

ma

s

PL

M (

i.e

. A

gile

, A

ren

ea

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mn

ify)

SA

P

Sh

are

Po

int

SR

M (

Ari

ba

, E

pic

or,

EP

IQ,

JD

A,

SA

P,

etc

.)

Tra

ckw

ise

(S

pa

rta

Syste

ms)

Oth

er

OTHERS:

AssurX CATSWeb Infor Movex M3

Audit Weaver MS Navision

Bespoke Neomatics

BLUe-CAT Synergy Optiva

BPCS Pharmschul (GMP Software)

Cama Software Prism

CIQA Prodom

CloudForge PROTEAN

CloudQMS Qasys

Compliance 360 Qualtrax

ComplianceControl Centre QUBE


Ensur Rover Data systems Millenium 3

Entropy SE SUITE - SOFTEXPERT

FoxPro Simple Trak

Harrington Group International Sword Achiever

HP Quality Center The QAB

IBS TIP QA

Intelex Title21

IQS Traction Teampage

Job Boss Vivaldi Software

Lotus Notes WMS

MetricStream

ADDITIONAL COMMENTS BY PARTICIPANTS



• Make use of secure / cloud based document repository. • We are in the process of implementing an ERP system and this will make it much easier to manage our Quality system. Full integration is

definitely the way forward. • It needs to be integral part of overall approach over all areas of the value chain QMS, DMS, Dossier management, RIM, IDMP, R&D, Clinical, PV. • Bite the bullet and go for it. Best thing we have done. • We have been planning an EQMS system, but there are only few systems that are available also for small companies. And systems that are able

to serve our company though the growth are in current situation expensive for us when costs for the start e.g. validation of the system are about the same as the system itself.

• I can't find a good one. They all look clunky at the back despite nice display functions at the front. They lack user interface capability to be intuitive. I get the impression they are all working off a similar 10-15year old backbone.

• Whichever system is used needs to be customized to suit needs of individual company, especially when transitioning form paper based. • Make sure they have a compliance consulting group available for help. • Sometimes getting started is the hardest part. A good systems evaluation will always get the ball rolling. If you don't have those resources on-

site using a consulting company can be a great place to start. really great job. No pressure, told us just what we needed with no overselling. • The best would be a QMS to incorporate all these modules and have reports for Management Review. • Integration is key. • Trouble making business case for quality related technology. • I prefer one large system that can manage as many aspects of my QMS as possible. • Next generation is SAP. • Commercial systems are complicated and not very intuitive. Always need customization (extra time and cost) and cost more than original

quotes. • If done correctly and with one system, the system can deliver the Annual Report for each product within hours instead of weeks if done

manually.

ADDITIONAL COMMENTS BY PARTICIPANTS • Global processes are challenging to create, deploy and maintain. • "Quality efforts should always be embedded in, and supportive of, the business operations. In my view, too many of the QMS software

systems are too standalone - they don't integrate with what the business is doing." • "QMS software systems are never accessible to everyone, which defeats the object." • "I have developed and implemented QMS software systems in some very large international companies - they weren't entirely successful

(the clients were happy) because the company culture prevented access by all." • People sometimes forget How / What they have to do and so leave it, then the efficiency of the system does not work. • Understand your processes and linkages and spend time mapping them out and improving them before turning to technology. Ensure

whatever system is chosen is scalable. • My company will introduce company wide SW platforms for these topics in the coming 1-2 years, as part of a Quality improvement

program. • Software tools are great, but the downfall I have found with multiple systems is the initial configuration that causes problems once in use.

It is well worth the time and effort engaging the software vendors early and getting robust feedback from your sites regarding how the system will be used in 5 years time to ensure that the configuration is thought through properly. Usually the system gets blamed for the problems a company has when it was the set up and knowledge regarding how it was to be used that was at fault.

• The full benefits of introducing an enabling technology are difficult to define but also, the costs of implementation and maintenance are often not well understood ( training and validation in particular).

• Enterprise Quality Management needs to lead to global corporate process standardization. • It is never what you want. You have always to change your existing process. • Many products tend to be 'over-built'. • PLM seems like the trend to integrate all business. • Would love to have QMS software system(s), but unable to afford at this time. • Virtual company - just starting our QMS electronically.



TOTAL LIST OF VENDOR SOFTWARE COMPANIES



123Compliance CIQA QA Manager Ensur Mystic

Accelrys CIS Entropy (BSI)

ApolloLIMS CloudForge e-Packmat

Arena PLM CloudQMS Epiware

ARISg Compliance 360 ePowerCenter

AssurX CatsWeb ComplianceControl Centre EthicsPoint

Audit Utopia Compliancewire (UL Eduneering) ETQ

Audit Weaver CoreLIMS eTraininfo

Axentis (Omnicare) Cornerstone FirstDoc

Beacon CTQ FoxPro

Bespoke CTS Grand Avenue

Blaze LIMS DCS Harrington Group International

BLUe-CAT Synergy DNV.GL Synergi HealthStream

Blue Mountain Documentum HP Quality Center

Breeze Docspace IBM FileNet

Bugzilla Dokeos IBM Rational Change

CALLS (Volos) Donor Dialogue's DRM Touch IBS

Cama Software eDocs Ideagen Workbench

CAP Software eMatrix IHS

Cebos Engage (HR Software) iLearning (Seertech)

Note: Many of the company and product names captured within the Comments section

of each question have not been validated.




Infor Movex M3 Learning Plus NovaTek

Infor Optiva Lims1 Noverant

InfoRouter Liquent OCS

Infotehna LiveDrive Omnify Empower

Intelex Lotus Notes OpenText LiveLink

Intertek MasterControl / QAAD Oracle

ION Simple Trak Maximo Oracle Argus

IQMS MES (Camstar, Epicor, Rockwell,

Siemens, SAP, Wonderware) Oracle Contract Manager

IQS MetricStream Oracle Harvest

IsoTrain Micros Inspire Oracle (Peoplesoft, Learn.com, etc.)

ITSM Microsoft CRM Oracle Siebel

JD Edwards Microsoft Dynamics Pastel

Jira (Atlassian) Microsoft Navision PDXpert

Job Boss Microsoft SharePoint Pharmschul (GMP Software)

Kintana Montrium Connect Pilgrim Software

Knowledge Tree Neomatics PLM software (i.e., Agile, Arena, Dassault,

Omnify, PTC, Siemens)

LabExpert NetRegulus PMED

Labtronics NextDocs PONDUS

Lab Vantage NorthStar PQMS

LabWare Northwest Analytics Prism






Prodom (I.A.C.T.) Rover Data Systems Millenium 3 Sword Achiever

Process Pro Saba Taleo

PROTEAN Sage TEDS

Q5 Systems Salesforce.com The QAB

QAD SAP Thermo Scientific

Qasys Software (Umbani) SAP (SuccessFactors, Plateau) TipQA

QPR SCEPTRE Title21

Q-Pulse ServiceNow Trackwise (Sparta Systems)

QSi Simple Trak Traction Teampage

QSTAT SLIM (InterCAX) Train Track (Halogen)

Quads Smart HR UniLab (Siemens)

Quality Online (Icologiq) SoftExpert Excellence Suite Uperform

Quality Works SoftTech QMS Veeva

Qualtrax Solabs Vivaldi Software

QUBE SQL*LIMS WindFarmManager

Qumas SRM (Ariba, Epicor, EPIQ, JDA, SAP) Workday

QuickControl StarLMS WMS

Redmine Stemsoft WQS

Regula SumTotal XEROX

Rivo Safeguard Sunquest ZenDoc

ZuMatrix



quality management system vendor software system use benchmark march2014

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