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OVERVIEW
The purpose of this survey was to collect data from life sciences companies on the 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 75,000
professionals worldwide. Over 342 members from the Life Sciences industry 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 challenge on configuring and sustaining quality software
especially globally. However, more than 42% do use enabling technology for managing many
aspects of their quality systems.

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.
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.

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

2
DEMOGRAPHICS
REPRESENTATION FROM PARTICIPANTS ABOUT THEIR INDUSTRY, COMPANY
ANNUAL REVENUE AND THEIR ROLE OR FUNCTION WITHIN THE COMPANY

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

3
INTERNAL/EXTERNAL AUDIT
OTHERS
(from comments):
Arena PLM
Audit Utopia
Entropy
CIQA
CloudForge
Compliance Control
Centre
Documentum
Ensur
LabExpert
Lotus Notes
Microsoft Navision
NextDocs
QAAD
QAB
QUIPS
ServiceNow
STEMSOFT
Title 21
Veeva

Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

4
CAPA
OT H E R S (fro m c o mme nts ):
Arena PLM
Bugzilla
CIQA
CloudForge
Compliance Control Centre
Compliancewire
Documentum
Entropy
Lotus Notes
NovaTek
Quads
QPR
Service Now
SOLABS
STEMSOFT
Veeva

Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

5
CHANGE CONTROL
OT H E R S (fro m c o mme nts ):
Arena PLM
Bugzilla
CIQA
CloudForge
Compliance Control Centre
Documentum
Entropy
Epicor Dataflo
IBM Rational
LabExpert
Lotus Notes
ManageEngine
NextDocs
Novatek
Quads
Sharepoint
Siemens TeamCenter
STEMSOFT
Veeva

Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

6
COMPLAINTS
OT H E R S (fro m c o mme nt):
Arena PLM
Bugzilla
CIQA
CloudForge
Compliance Control Centre
Compliancewire
CTQ Software
Documentum
Entropy
IQMS
LabExpert
Lotus Note
PQMS 6P
Quads
Savant
ServiceNow

Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

7
DOCUMENT MANAGEMENT
OT H ER S
(fro m c o mme nts ):
CIQA
CloudForge
Compliance Control Centre
Ensur
Entropy
Epiware
LabExpert
NovaTek
Regula
STEMSOFT
Vivaldi

Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

8
EXCEPTIONS
OT H E R S
(fro m c o mme nts ):
Blue Mountain
CIQA
CloudForge
Compliance Control Centre
Compliancewire
Entropy
Epiware
Kintana
Lotus Notes
NextDocs
NovaTek
Quads
ServiceNow
STEMSOFT

Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

9
LABORATORY MANAGEMENT

OT H E R S
(fro m c o mme nts ):
H&A Scientific SLIM
Lotus Notes
Maximo
Oracle
SAP
Siemens (UniLab)
Zumatrix

Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

10
TRAINING
OT H E R S
(fro m c o mme nts ):
CIQA
CloudForge
Compliance Control Centre
Dokeos
Ensur
Entropy
HealthStream
iLearn
Learning Plus
Lotus Notes
NextDocs
NovaTek
Noverant LMS
STEMSOFT
Veeva

Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

11
SUPPLIER QUALITY
OT H E R S
(fro m c o mme nts ):
Arena PLM
CIQA
CloudForge
Compliance Control Centre
Ensur
Entropy
Lotus Notes
MS Navision
Omnify
Pharmschul
Savant
SharePoint

Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

12
ADDITIONAL COMMENTS BY PARTICIPANTS
“Sometimes getting started is the hardest part. A good systems evaluation will always
get the ball rolling”

“There is no a one system that can help you to manage your quality management
system.”
“Integration is key.”

“Trouble making business case for quality related technology.”
“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.”
“Global processes are challenging to create, deploy and maintain.”
“People sometimes forget how / what they have to do and so leave it, then the
efficiency of the system does not work.”

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

13
ADDITIONAL COMMENTS BY PARTICIPANTS
“Understand your processes and linkages and spend time mapping them out and
improving them before turning to technology.”
“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).”
“PLM seems like the trend to integrate all business.”

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

14
QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

15
TOTAL LIST OF VENDOR SOFTWARE COMPANIES
123Compliance

Dassault (MatrixOne, Enovia)

Liberty Labs (TrainTrack)

Saba

Accelrys
Agile (Oracle)

DevTech (Pathlore)

Lotus Notes

Salesforce.com

Documentum

ManageEngine

SAP (QM, Plateau, SuccessFactors)

Arena Solutions

Dokeos

MasterControl (QAAD)

Savant Software

Aris Global

Eduneering

MetricStream (QualityStream)

ServiceNow

AssurX

Epicor

Microsoft Navision

SharePoint

Blaze Systems

Epiware

Mystic Management Systems (Ensur)

Siemens (TeamCenter,UniLab)

Blue Mountain

ETQ

Solabs

BLU-e-CAT Synergy

GMP Software GmbH (Pharmschul)

need ot look up company name and product
NextDocs

BSI (Entropy)

Novatek International

StarLIMS

Bugzilla

H&A Scientific (SLIM)
HealthStream

Noverant

STEMSOFT

Cama Software

HP Software (Kintana)

Omnify Software

SumTotal

CambridgeSoft

IBM (FileNet Maximo, Rationale)

Oracle (Agile, Argus, PeopelSoft, Quality, Siebel)

Sword Achiever

Camstar

IBS

Orcle (iLearn)

TEDS Inc.

Cebos

Intelex

Partner Point (Grand Avenue)

Thermo Scientific

CIMCON Software (eTraininfo)

Invensys (Wonderware)

Pilgrim Software

Title 21

CIQA

IQS

PQMS 6P

Veeva

CloudForge

IQMS

PSC Software (Audit Utopia)

Zumatrix

Compliance Control Centre

ISOTrain

PTC (NetRegulus, NetRM, Global Quality, Windchill)

Compliance360

ISS AG (Regula)

QIS (Quads)

Compliancewire

LabExpert

Q-Pulse

CoreLIMS

Labtronics

QPR Software

Cornerstone

LabVantage

Quality Advisory Board (QAB)

CSC (FirstDoc)

LabWare

Qumas

CTQ Software

LearningPlus

Rockwell

Sparta Systems (Trackwise)

QUALITY & REGULATORY NETWORK
Copyright 2014 Quality & Regulatory Network

16

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Life sciences quality management system vendor software benchmark survey feb2014

  • 1.
  • 2. OVERVIEW The purpose of this survey was to collect data from life sciences companies on the 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 75,000 professionals worldwide. Over 342 members from the Life Sciences industry 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 challenge on configuring and sustaining quality software especially globally. However, more than 42% do use enabling technology for managing many aspects of their quality systems. 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. 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. QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 2
  • 3. DEMOGRAPHICS REPRESENTATION FROM PARTICIPANTS ABOUT THEIR INDUSTRY, COMPANY ANNUAL REVENUE AND THEIR ROLE OR FUNCTION WITHIN THE COMPANY QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 3
  • 4. INTERNAL/EXTERNAL AUDIT OTHERS (from comments): Arena PLM Audit Utopia Entropy CIQA CloudForge Compliance Control Centre Documentum Ensur LabExpert Lotus Notes Microsoft Navision NextDocs QAAD QAB QUIPS ServiceNow STEMSOFT Title 21 Veeva Only represents those vendors that had selections from the entire list. *Source Data: LinkedIn Quality & Regulatory Network Group, February 2014 QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 4
  • 5. CAPA OT H E R S (fro m c o mme nts ): Arena PLM Bugzilla CIQA CloudForge Compliance Control Centre Compliancewire Documentum Entropy Lotus Notes NovaTek Quads QPR Service Now SOLABS STEMSOFT Veeva Only represents those vendors that had selections from the entire list. *Source Data: LinkedIn Quality & Regulatory Network Group, February 2014 QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 5
  • 6. CHANGE CONTROL OT H E R S (fro m c o mme nts ): Arena PLM Bugzilla CIQA CloudForge Compliance Control Centre Documentum Entropy Epicor Dataflo IBM Rational LabExpert Lotus Notes ManageEngine NextDocs Novatek Quads Sharepoint Siemens TeamCenter STEMSOFT Veeva Only represents those vendors that had selections from the entire list. *Source Data: LinkedIn Quality & Regulatory Network Group, February 2014 QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 6
  • 7. COMPLAINTS OT H E R S (fro m c o mme nt): Arena PLM Bugzilla CIQA CloudForge Compliance Control Centre Compliancewire CTQ Software Documentum Entropy IQMS LabExpert Lotus Note PQMS 6P Quads Savant ServiceNow Only represents those vendors that had selections from the entire list. *Source Data: LinkedIn Quality & Regulatory Network Group, February 2014 QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 7
  • 8. DOCUMENT MANAGEMENT OT H ER S (fro m c o mme nts ): CIQA CloudForge Compliance Control Centre Ensur Entropy Epiware LabExpert NovaTek Regula STEMSOFT Vivaldi Only represents those vendors that had selections from the entire list. *Source Data: LinkedIn Quality & Regulatory Network Group, February 2014 QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 8
  • 9. EXCEPTIONS OT H E R S (fro m c o mme nts ): Blue Mountain CIQA CloudForge Compliance Control Centre Compliancewire Entropy Epiware Kintana Lotus Notes NextDocs NovaTek Quads ServiceNow STEMSOFT Only represents those vendors that had selections from the entire list. *Source Data: LinkedIn Quality & Regulatory Network Group, February 2014 QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 9
  • 10. LABORATORY MANAGEMENT OT H E R S (fro m c o mme nts ): H&A Scientific SLIM Lotus Notes Maximo Oracle SAP Siemens (UniLab) Zumatrix Only represents those vendors that had selections from the entire list. *Source Data: LinkedIn Quality & Regulatory Network Group, February 2014 QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 10
  • 11. TRAINING OT H E R S (fro m c o mme nts ): CIQA CloudForge Compliance Control Centre Dokeos Ensur Entropy HealthStream iLearn Learning Plus Lotus Notes NextDocs NovaTek Noverant LMS STEMSOFT Veeva Only represents those vendors that had selections from the entire list. *Source Data: LinkedIn Quality & Regulatory Network Group, February 2014 QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 11
  • 12. SUPPLIER QUALITY OT H E R S (fro m c o mme nts ): Arena PLM CIQA CloudForge Compliance Control Centre Ensur Entropy Lotus Notes MS Navision Omnify Pharmschul Savant SharePoint Only represents those vendors that had selections from the entire list. *Source Data: LinkedIn Quality & Regulatory Network Group, February 2014 QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 12
  • 13. ADDITIONAL COMMENTS BY PARTICIPANTS “Sometimes getting started is the hardest part. A good systems evaluation will always get the ball rolling” “There is no a one system that can help you to manage your quality management system.” “Integration is key.” “Trouble making business case for quality related technology.” “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.” “Global processes are challenging to create, deploy and maintain.” “People sometimes forget how / what they have to do and so leave it, then the efficiency of the system does not work.” QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 13
  • 14. ADDITIONAL COMMENTS BY PARTICIPANTS “Understand your processes and linkages and spend time mapping them out and improving them before turning to technology.” “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).” “PLM seems like the trend to integrate all business.” QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 14
  • 15. QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 15
  • 16. TOTAL LIST OF VENDOR SOFTWARE COMPANIES 123Compliance Dassault (MatrixOne, Enovia) Liberty Labs (TrainTrack) Saba Accelrys Agile (Oracle) DevTech (Pathlore) Lotus Notes Salesforce.com Documentum ManageEngine SAP (QM, Plateau, SuccessFactors) Arena Solutions Dokeos MasterControl (QAAD) Savant Software Aris Global Eduneering MetricStream (QualityStream) ServiceNow AssurX Epicor Microsoft Navision SharePoint Blaze Systems Epiware Mystic Management Systems (Ensur) Siemens (TeamCenter,UniLab) Blue Mountain ETQ Solabs BLU-e-CAT Synergy GMP Software GmbH (Pharmschul) need ot look up company name and product NextDocs BSI (Entropy) Novatek International StarLIMS Bugzilla H&A Scientific (SLIM) HealthStream Noverant STEMSOFT Cama Software HP Software (Kintana) Omnify Software SumTotal CambridgeSoft IBM (FileNet Maximo, Rationale) Oracle (Agile, Argus, PeopelSoft, Quality, Siebel) Sword Achiever Camstar IBS Orcle (iLearn) TEDS Inc. Cebos Intelex Partner Point (Grand Avenue) Thermo Scientific CIMCON Software (eTraininfo) Invensys (Wonderware) Pilgrim Software Title 21 CIQA IQS PQMS 6P Veeva CloudForge IQMS PSC Software (Audit Utopia) Zumatrix Compliance Control Centre ISOTrain PTC (NetRegulus, NetRM, Global Quality, Windchill) Compliance360 ISS AG (Regula) QIS (Quads) Compliancewire LabExpert Q-Pulse CoreLIMS Labtronics QPR Software Cornerstone LabVantage Quality Advisory Board (QAB) CSC (FirstDoc) LabWare Qumas CTQ Software LearningPlus Rockwell Sparta Systems (Trackwise) QUALITY & REGULATORY NETWORK Copyright 2014 Quality & Regulatory Network 16