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.
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DEMOGRAPHICS REPRESENTATION FROM PARTICIPANTS ABOUT THEIR INDUSTRY, COMPANY
ANNUAL REVENUE AND THEIR ROLE OR FUNCTION WITHIN THE COMPANY
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INTERNAL/EXTERNAL AUDIT
4
Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014
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
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
CAPA
5
Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014
OT HERS (fro m co mme nts):
Arena PLM
Bugzilla
CIQA
CloudForge
Compliance Control Centre
Compliancewire
Documentum
Entropy
Lotus Notes
NovaTek
Quads
QPR
Service Now
SOLABS
STEMSOFT
Veeva
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
CHANGE CONTROL
6
Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014
OT HERS (fro m co 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
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
COMPLAINTS
7
Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014
OT HERS (fro m co mme nt):
Arena PLM
Bugzilla
CIQA
CloudForge
Compliance Control Centre
Compliancewire
CTQ Software
Documentum
Entropy
IQMS
LabExpert
Lotus Note
PQMS 6P
Quads
Savant
ServiceNow
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
DOCUMENT MANAGEMENT
8
Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014
OT HERS
(fro m co mme nts):
CIQA
CloudForge
Compliance Control Centre
Ensur
Entropy
Epiware
LabExpert
NovaTek
Regula
STEMSOFT
Vivaldi
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
EXCEPTIONS
9
Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014
OT HERS
(fro m co mme nts):
Blue Mountain
CIQA
CloudForge
Compliance Control Centre
Compliancewire
Entropy
Epiware
Kintana
Lotus Notes
NextDocs
NovaTek
Quads
ServiceNow
STEMSOFT
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
LABORATORY MANAGEMENT
10
Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014
OT HERS
(fro m co mme nts):
H&A Scientific SLIM
Lotus Notes
Maximo
Oracle
SAP
Siemens (UniLab)
Zumatrix
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
TRAINING
11
Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014
OT HERS
(fro m co mme nts):
CIQA
CloudForge
Compliance Control Centre
Dokeos
Ensur
Entropy
HealthStream
iLearn
Learning Plus
Lotus Notes
NextDocs
NovaTek
Noverant LMS
STEMSOFT
Veeva
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
SUPPLIER QUALITY
12
Only represents those vendors that had selections from the entire list.
*Source Data: LinkedIn Quality & Regulatory Network Group, February 2014
OT HERS
(fro m co mme nts):
Arena PLM
CIQA
CloudForge
Compliance Control Centre
Ensur
Entropy
Lotus Notes
MS Navision
Omnify
Pharmschul
Savant
SharePoint
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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.”
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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.”
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TOTAL LIST OF VENDOR SOFTWARE COMPANIES
16
123Compliance Dassault (MatrixOne, Enovia) Liberty Labs (TrainTrack) Saba
Accelrys DevTech (Pathlore) Lotus Notes Salesforce.com
Agile (Oracle) 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 need ot look up company name and product Solabs
BLU-e-CAT Synergy GMP Software GmbH (Pharmschul) NextDocs Sparta Systems (Trackwise)
BSI (Entropy) H&A Scientific (SLIM) Novatek International StarLIMS
Bugzilla 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
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