2016 Quality Management System Vendor Software Benchmark Report

Quality & Regulatory Network LLC
Copyright 2016 Quality & Regulatory Network LLC. All Rights Reserved.

*Source Data 2016: LinkedIn Quality & Regulatory Network Group, other LinkedIn Groups, email campaigns.
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2Quality & Regulatory Network LLC

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INTRODUCTION
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 109,000
professionals worldwide. Over 400 members from multiple industries participated.
Percentages do not reflect data for market size, vendor market share or leadership
position. Data only reflects vendor selections from survey participants.
Listing of all Software Vendors mentioned by participants in this survey can be found in the Appendix. Not all
vendors may be represented in their category. If you are a Vendor that is not currently on our list, we welcome
the chance to have you participate in the 2017 QMS Vendors Benchmark Survey.
Any questions about this Survey can be sent to Nikki Willett, Founder/Owner LinkedIn Quality & Regulatory
Network.
The Quality & Regulatory Network would like to thank our helpers in creating the base report. I would also like
to give special recognition and thanks to my Partners C.M. Schramm and Bob Mehta for their on-going support
and help in getting this report finished. I couldn’t do this without their expertise, dedication and quality control.
Thank you Clare and Bob!
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.

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SPECIAL THANK YOU TO OUR 2016 SPONSORS
A very big thank you to our Platinum
Sponsor, Arena Solutions, and all of our
sponsors – Gold, Silver and Bronze. Your kind
support allows us the resources to research,
analyze and finalize the QMS Benchmark
Report. An additional thank you goes out to
our media sponsors helping us to announce
the Survey Launch and Final Report
availability. Thanks again!Cognizant MedVantage
Cybermetrics
FormPipe
MasterControl
Motto Systems
Traction Software
PLATINUM SPONSOR
BRONZE SPONSORS
SILVER SPONSORS
GOLD SPONSORS
MEDIA SPONSORS

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OBSERVATIONS AND COMMENTS FOR 2016
Demographics - Industry
Not surprising that the Life Sciences (Biotech, Medical Device, Pharmaceuticals) industry maintains the leadership position in responding
to the Survey as thy are the most vocal in the LinkedIn Quality & Regulatory Network group. However, we are seeing growth in other
industries such as Laboratories potentially impacted by Health Care regulations or threat to move control under FDA.
With the growing complexity of global regulatory changes and their impact on Quality, larger companies are trying to improve their
visibility across the entire enterprise by consolidating and standardizing on a single QMS platform. More large and boutique consulting
firms are now recognizing that Quality and its QMS software are taking a more prominent role in the supply chain with enterprise system
implementations. Not quite an ERP implementation complexity, but the paradigm shift from easily managed site “antiquated” systems
and paper-based models are causing challenges in enterprise-wide cultural adoption that change and automation are a “good thing.”
Greater facilitation and leadership support will be greatly needed to see the change in the Quality Maturity to the next level.
Demographics - Company Size / Revenue
Half of the participants were from small companies with revenues less than 100M. The interest in deciding on keeping paper or starting
with automation as they progress to their first product submissions is high on the minds of these companies. Although low in funding for
automation, many of these companies are seeing the benefits of starting automation now, such as Document Management, to set the
structure of the company before it becomes wild and crazy with barely a breath to stop and consider trying to fit in an electronic system
implementation. These small companies are ideal to leverage the technology, sustainability and cost of Cloud-based solutions.
Demographics – Survey Participants
More than 80% of the (blind) participants took this survey for the first time. Some participants may have not taken the survey again has
things had not changed from previous years. To be more accurate in our figures, we are looking at ways for prior participants to easily
state that the new year hasn’t really changed.
5

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Functional Categories – Vendor Profiles
A plethora of vendors were selected for each of the categories, as seen in the charts. These may be a result of companies having more
than one system and therefore doing a multi-selection or the result of the new Cloud-born solutions representing the smaller
companies embracing the technology into their overall growth plan. A few of these vendors listed last year are no longer with us
showing us only the strong survive or get acquired.
Some Feedback from Participants Concerning their System of Use:
• Licensing costs for companies consolidating into one instance for the enterprise
• Companies need to stay on top of the vendor during implementation
• Length of time some systems take to get up and running
• Global use is hindered by time zone issues
• Consolidation, migration and cultural adoption
• Workflow process is complex to configure and maintain
• Challenge or lack of interfaces to other manufacturing and document management systems
• Standard QMS does not work well with contract manufacturers
• Need better interface between call center system and complaint handling solution. Vendor does not have good business sense of
different call types.
• Need guide for country jurisdiction and regulations of complaints globally
• Many solutions not providing OOS especially for lab
• Not all QMS systems connect well with GMP Training System
• Support outside the client time zone
• Validation challenges
• Cost is high
• User interface is not intuitive
• Not impressed with Top IT provider GxP capabilities and understanding business needs
6

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Most of the comments were focused on the difficulty of implementation, especially global, working with the software vendor
and finally costs. Larger companies are maturing and through M&As have the need to consolidate all their systems into a
single enterprise instance. With that comes the cost not just from the vendor, but the internal costs spent on having
dedicated resources from IT and especially business throughout the entire project. Vendors need guidance and may not
understand the terminology of the business. Complexities like data migration, multiple integration, master data and archiving
are all things that need to be planned upfront before finding out too late additional requirements and complexities that just
pop up.
Some solutions like Calibration and SPC especially at a plant site, although critical to the overall manufacturing process, is not
the highest priority in converting to an automated solution and hence many are still using manual processes (including index
cards). The interest from quality and manufacturing engineers is high to help reduce work overload, but the progress is slow.
Most are satisfied if they move to the functionality contained within their ERP or just tracking solutions provided by QMS
software vendors.
Complaint handling and CAPA may be the ones that have more complex process of all the functional areas, but after all a
CAPA is a CAPA. However, those organizations that try to replicate their paper-based processes, may just find the things that
weren’t working before in a manual process are still not working when automated. This is because companies are trying to
automate every detail for every type of workflow around each specific product class, country, and other attributes, or are
trying to force-fit functionality into a software solution not built for it. Each approach causes complexity and typically results
in a user interface that is not intuitive especially for infrequent users. Customization or lengthy configurations will also make
the cost higher for implementation and maintenance. Good rule is 80% out-of-the-box and 20% formatting changes or
additional configuration. Lastly, with the changing global regulatory landscape, companies not only need to think of country
jurisdiction when a complaint occurs but bring regulatory into the fold of manufacturing release so the right product is
released to the right country at the right time.
7

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8
LIMS and MES still appear to have automation adoption challenges. A lot of companies are using
manual processes in the lab or on the shop floor. Although a lot of opportunity for growth, typically
there is no clear strategy for automation or integration with other systems. Batch records are still
predominantly paper-based, a risk for accuracy and compliance, and you can still find rooms filled
with locked cabinets.
Still considered a relatively new idea in some industries, we’ve seen changes recently with PLM. In the
past, PLM was owned by Development/Engineering. However, since Quality is across the entire
product value chain we are now seeing many organization shift the ownership to Quality resulting in
PLM vendors adding more functionality to support product quality lifecycle. Although on the rise,
many companies still lack a PLM and try to make up for it by using many different systems – adding to
the complexity for their users.
It’s not surprising to hear that Top IT providers implementing quality solutions do not have impressive
GxP capabilities nor understand the business. SMEs with a background in GMP, Validation, Quality and
how it’s applied with Vendor Software are the ones that can provide guidance to an IT provider during
a project implementation. This role is critical to any QMS implementation success. But do not think
that all delivery people whether on-shore or off-shore will have this kind of knowledge except for
what they hear when on-boarded to the project.

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Technology Trends
Last year there were a greater number of participants saying they had no cloud-based solutions within their organization. This year is
50% less. Although Cloud technologies increasingly become mainstream, only 30% of respondents think Cloud is a positive trend for
Quality Management Systems. While many organizations embrace Cloud, security and regulatory compliance concerns are a limiting
factor to broader adoption. Lack of GAMP and FDA guidelines for SaaS and Cloud-based systems are also a major concern.
Although Cloud and security was mentioned many times, the biggest trends that participants are watching are Mobility and Digital
Transformation
Other Observations – Years Used, Satisfaction, Installation, Implementation
Most participants said they have been using their systems from 1-3 years and only a small portion had something implemented within
the last year. As companies may evaluate their software lifecycle from 3-5 years, we might see an uptick in new system acquisitions
especially for CAPA, nonconformances and deviations especially on the shop floor and replacing old or adding new document
management systems. The uptick in Document Management can be either small companies embracing automation or a plethora of
lower cost Cloud solutions being available.
For the most part, even seeing issues and challenges with their system and vendor as part of the survey feedback, participants mostly
felt good about their QMS system.
Companies are still trying to everything themselves including implementing QMS systems with some help from the vendor. This
approach may be overwhelming to IT and especially to Business and may cause a company to miss out on the benefits of leading
practices that both a software vendor and service providers can provide from vast experience with customers. Over run projects,
difficulties keeping to schedules is not the fault of internal resources nor vendors, but the lack of having resources dedicating time to a
project.
Consideration on external resources may be need to help drive the strategy and roadmap before jumping directly into a large program
implementation, especially those that are enterprise-wide or have multiple business units involved.
9

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NUMBER ONE CHALLENGE
Although cost is always on the top 3 of the
list of challenges in implementing a Quality
system, the feedback on the number one
challenge is cultural adoption. Users
comfortable with paper need early training
on the benefits of automation for their
own job, department and company. In
addition, the voice of the company needs
to be heard even if implementation will be
done in another phase or year. Leaders
need to be very supportive and help
commit to the long term investment. If
culture is not considered as part of
planning phase of a new Quality system,
there will be greater potentials for failures.
10

IF YOU’RE GOING TO RISE TO
THE CHALLENGE, YOU HAVE TO
BE PREPARED TO CHANGE.

Internal/External Audit
Calibration & Maintenance
CAPA (Corrective & Preventive Actions)
Change Control
Complaints
Document Management
Exceptions (Deviations, Non-conformances)
Environmental Health & Safety (EH&S)
Laboratory Management (LIMS, ELN)
Manufacturing Execution System (MES)
Product Lifecycle Management (PLM)
Statistical Process Control (SPC/PAT)
Supplier Quality
Training
SaaS / Cloud Systems Usage
Challenge in Implementation
Technology Trends Impacting QMS
Resources Needed for On-Going QMS success
Selected Comments from Participants
Appendix I –Selected Vendor Profiles
Appendix II –Vendor List

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DEMOGRAPHICS
REPRESENTATION FROM PARTICIPANTS ABOUT THEIR INDUSTRY
1.1%
1.3%
1.1%
1.3%
10.5%
1.3%
1.6%
11.1%
2.9%
2.6%
2.1%
1.3%
1.6%
12.4%
10.3%
1.8%
21.1%
3.4% 11.2%
Academic Research
Aerospace & Defense
Airlines / Aviation
Automotive
Biotechnology
Chemicals
Contract Partner
Consulting
Electrical & Electronic Manufacturing
Food & Beverages
Hospital & Health Care
Information Technology & Services
Laboratory
Life Science Multi-Sector
Medical Device / Diagnostic / Software
Mining, Metals, Paper, Plastics
Pharmaceuticals
Software Vendor for QMS
Other
Bio
Med
Pharma
Life Science
Multi-Sector

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COMPARISON OF INDUSTRY TO 2015
1.1% 1.3% 1.1% 1.3%
10.5%
1.3% 1.6%
11.1%
2.9%
2.6%
2.1% 1.3% 1.6%
12.4%
10.3%
1.8%
21.1%
3.4%
11.2%
3.5%
1.5%
12.4%
1.1%
1.3%
4.3%
3.8% 4.6%
17.6%
35.5%
14.4%
0%
5%
10%
15%
20%
25%
30%
35%
40%
2016 2015

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DEMOGRAPHICS
REPRESENTATION FROM PARTICIPANTS ABOUT THEIR COMPANY ANNUAL REVENUE
M – Million B - Billion
31.8%
15.8%
8.4%
12.4%
3.7%
3.9%
10.5%
6.6%
2.9% 1.6% 2.4% less than 25M
26-50M
51-100M
101-500M
500-750M
750M-1B
1-5B
5-10B
11-25B
26-50B
Over 50B

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COMPARISON OF ANNUAL REVENUE TO 2015
38.4%
34.8%
8.9%
17.9%
31.8%
15.8%
8.4%
12.4%
3.7% 3.9%
10.5%
6.6%
2.9%
1.6%
2.4%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
2015 2016

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DEMOGRAPHICS
REPRESENTATION FROM PARTICIPANTS ABOUT THEIR ROLE OR FUNCTION WITHIN THE COMPANY
5.5%
5.5%
2.1%
8.7%
4.5%
4.2%
39.2%
3.4%
3.4%
0.5%
0.8%
1.6%
0.3%
0.5%
0.3%
2.9%
16.6%
Compliance
Engineering
Exec/C-Suite
IT
Management
Manufacturing
Quality Assurance
Quality Control
Regulatory
Risk
R&D
Safety
Security
Supply Chain
Sustainability
Training / HR
Validation

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COMPARISON OF ROLES TO 2015
Note: Some answers were consolidated under one industry while those with only
a single response were allocated to "Other."
8.2%
5.7%
8.7%
3.1%
35.3%
15.4%
7.5%
0.1%
2.7%
0.6% 0.7% 0.3%
11.7%5.5%
5.5%
2.1% 8.7%
4.5%
4.2%
39.2%
3.4% 3.4%
0.5%
0.8%
1.6% 0.3%
0.5% 0.3% 2.9%
16.6%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
2015 2016

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DEMOGRAPHICS 2016
REPRESENTATION FROM PARTICIPANTS ABOUT THEIR GEOGRAPHICAL REGION
64.7%
1.6%
0.8%
12.6%
0.3%
2.1%
0.8% 17.1% North America
Central America
South America
Europe
Eastern Europe
Africa
Middle East
Asia Pacific

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COMPARISON OF GEOGRAPHICAL
REPRESENTATION TO 2015
62%
14%
20%
2% 2%
13%
64.7%
1.6% 0.8%
12.6%
0.3%
2.1%
0.8%
17.1%
0%
10%
20%
30%
40%
50%
60%
70%
North
America
Central
America
South
America
Europe Eastern
Europe
Africa Middle East Asia Pacific
2015 2016

Please note that each Category has 5 parts:
• Top 2016 Vendors Selected
• Vendor list of “Other” with less than 1%
response
• Time & Satisfaction with the System
• Installation & Implementation of the System
• Comparison to the 2015 Benchmark

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INTERNAL / EXTERNAL AUDIT SYSTEM
21
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 “Other.” Those vendors with no selection are still reflected in the Appendix.
24%
1%
27%
1%1%
10%
4%
1%
7%
1%
3%
3% 5%
2%
2%
5%
Manual / Microsoft Office
Custom/Internally Developed
ACE (PSC Software)
AutoSHEQ
Cebos
ETQ
GMPPro (MOTTO Systems)
JIRA (Atlassian)
MasterControl
Q-Pulse (Gael)
SAP
SharePoint (Microsoft)
Trackwise (Sparta Systems)
Verse
ZenQMS
Other

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LIST OF OTHER AUDIT VENDORS*
123Compliance (Sparta Systems)
AMPLEXOR
Compliance Control
ComplianceQuest
Documentum Compliance Manager
Ennov Software Solutions
Enovia PLM (Dassault Systemes)
Formpipe.GxP (Formpipe Software AB)
Harrington Group International
HP Quality Center (QC)
IQS, Inc.
MetricStream
NextDocs
Optiva PLM (Infor)
Oracle
QA Systems (QASYS)
QAD
QPR Software PLC
Qualtrax
Qumas (Dassault Systemes)
Rescop
Salesforce
ServiceNow
* Those software vendors with 0% response are not reflected in this table but are included in this list of Vendors in the Appendix.

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4%
8%
24%
37%
28%
Awful Poor Average Good Excellent
20.9%
27.2%
13.7%
5.1%
14.3%
< 1 year 1-3 years 4-6 years 7-9 years > 10 years
TIME SATISFACTION
TIME & SATISFACTION WITH AUDIT SYSTEM

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INSTALLATION & IMPLEMENTATION OF AUDIT SYSTEM
33.7%
31.6%
2.1%
0.9%
0.9%
Totally Internal
Worked with Software Vendor
Used a local service provider
Used boutique service provider
Used top IT service provider
32.8%6.6%
8.7%
5.4%
On-Premise
3rd Party Hosted
Cloud/SaaS Single Tenant
Cloud/SaaS Multiple Tenant
INSTALLATION IMPLEMENTATION

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COMPARISON OF AUDIT TO 2015
23.6%
1.2%
27.4%
1.7% 1.7%
10.1%
3.7%
0.0%
1.7%
7.5%
0.9% 0.3%
1.4%
3.2% 2.6%
5.5%
2.0% 2.0%
24.6%
7.1%
17.9%
0.0% 0.5%
1.5%
0.7%
2.1%
1.2%
6.0%
2.3% 1.8% 1.8%
4.6%
3.5%
6.9%
0.3%
1.0%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0% 2016 2015

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CALIBRATION & MAINTENANCE (CMMS & PM)
26
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.
21.7%
4.5%
21.3%
1.4%
3.6%4.5%
1.4%
5.4%
1.8%
5.9%
1.4%
1.8%
1.4% 4.5%
1.8%
1.4% 5.9%
10.4%
ACE (PSC Software)
AutoSHEQ
Blue Mountain
Calman (SpectraCal)
Cebos
ETQ
GAGEtrak (CyberMetrics Corporation)
IQS, Inc.
JD Edwards (Oracle)
MasterControl
Maximo (IBM)
ProCAL (Prime Technologies)
Q-Pulse (Gael)
SAP
Other

Sponsored by
LIST OF OTHER CALIBRATION & MAINTENANCE
VENDORS*
Access Automation (UCAL)
Ape Software
CERDAAC (Simco Electronics)
Gage Insite (Indysoft Corporation)
GageManager (Altegra)
GAGEpack (PQ Systems)
iBASEt
IBS US
Infor EAMS
LabVantage
Labware
QAD
Quality Systems Toolbox
Rescop
TrackPro
uniPoint Software
Vintara

Sponsored by
TIME & SATISFACTION WITH CALIBRATION &
MAINTENANCE SYSTEM
TIME SATISFACTION
11.5%
23.4%
8.7%
4.8%
31.7%
1-3 years 4-6 years 7-9 years Other
3%
13%
29%
32%
23%

Sponsored by
INSTALLATION & IMPLEMENTATION OF
CALIBRATION & MAINTENANCE SYSTEM
31.7%
3.2%
4.8%
2.2%
On-Premise
3rd Party Hosted
37.3%
37.3%
3.1%
0.3%
0.7%
21.4%
Totally Internal
Other

Sponsored by
COMPARISON OF CALIBRATION &
MAINTENANCE TO 2015
17.0%
3.5%
16.6%
4.6% 4.6% 4.2%
3.5% 3.5%
2.8%
1.4% 1.4% 1.4%
14.4%
3.2%
0.9%
1.4%
4.5%
0.9%
0.2%
4.2%
8.0%
0.0%
1.7%
0.9%
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
2016 2015

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CAPA (CORRECTIVE & PREVENTIVE ACTIONS)
16.0%
2.3%
21.7%
1.0%
13.7%
4.3%
1.3%
8.7%
1.0%
1.7%
1.0%
2.0%
2.3%
8.0%
2.3%
3.3%
9.3%
ACE (PSC Software)
AutoSHEQ
ETQ
IQS, Inc.
MasterControl
Pilgrim
Q-Pulse (Gael)
SAP
Verse
ZenQMS
Other

Sponsored by
LIST OF OTHER CAPA VENDORS*
123Compliance
Cebos
ComplianceQuest
Empower PLM (Omnify Software)
Ideagen PLC
JIRA (Atlassian)
MetricStream
Omnex
QPR Software PLC
Qualtrax
Redmine
Rescop
TeamPage (Traction Software)
uniPoint Software

Sponsored by
TIME & SATISFACTION WITH CAPA SYSTEM
TIME SATISFACTION
18.0%
35.3%
12.9%
6.1% 11.2%
4%
8%
23%
35%
31%

Sponsored by
INSTALLATION & IMPLEMENTATION OF CAPA
37.3%
37.3%
3.1%
0.3%
0.7% 21.4%
Totally Internal
37.3%
6.4%
8.5%
6.4%
On-Premise
3rd Party Hosted

Sponsored by
COMPARISON OF CAPA SYSTEM TO 2015
14.7%
2.1%
19.9%
0.0%
12.6%
4.0%
0.0%
8.0%
0.0%
1.5% 1.8% 2.1%
7.4%
2.1%
3.1%
22.0%
7.1%
9.9%
1.1%
2.4%
1.3% 1.1%
6.6%
1.1%
1.5% 3.3%
1.5%
11.5%
0.2% 0.7%
0%
5%
10%
15%
20%
25%
2016 2015

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CHANGE CONTROL
19%
3%
21%
1.0%1.3%
7%
4%
1.0%
1.0%
10%
1.0%
1.0%
2%
5%
1.3%
2%
18%
ACE (PSC Software)
Agile PLM (Oracle)
AutoSHEQ
ETQ
IQS, Inc.
JIRA (Atlassian)
MasterControl
SAP
Verse
ZenQMS
Other

Sponsored by
LIST OF OTHER CHANGE CONTROL VENDORS*
Arena Solutions
Documentum (EMC)
eMatrix/Matrix One PLM (Dassault Systemes)
ISTM (Remedy)
QAD
Qualtrax
Remedy ARS (BMC)
Rescop

Sponsored by
TIME & SATISFACTION WITH CHANGE CONTROL
SYSTEM
TIME SATISFACTION
16.2%
28.9%
11.6%
6.1%
9.7%
4%
9%
26%
34%
27%

Sponsored by
INSTALLATION & IMPLEMENTATION OF CHANGE
CONTROL SYSTEM
35.2%
4.2%
8.0%
5.2%
On-Premise
3rd Party Hosted
33.0%
23.1%
1.3%
0.3% 1.0%
Totally Internal

Sponsored by
COMPARISON OF CHANGE CONTROL SYSTEM
TO 2015
19.0%
3.0%
21.0%
1.0%
0.3%
7.0%
4.0%
10.0%
0.0%
1.0%
2.0%
5.0%
1.3%
2.0%
23.6%
7.0%
10.6%
3.0%
1.3% 1.3% 1.3%
7.0%
1.5%
3.0% 2.6%
10.0%
0.2% 0.7%
0%
5%
10%
15%
20%
25%
2016 2015

Sponsored by
COMPLAINTS - PRODUCT QUALITY
17.2%
5.7%
1.1%
23.7%
1.5%
9.2%
4.6%
1.1%
1.9%
6.5%
1.1%
1.1% 3.8%
1.9% 4.6%
1.9%
2.3%
10.7%
ACE (PSC Software)
AutoSHEQ
ETQ
IQS, Inc.
JIRA (Atlassian)
MasterControl
Microsoft Dynamics
Pilgrim
Salesforce
SAP
Verse
ZenQMS
Other

Sponsored by
LIST OF OTHER PRODUCT QUALITY
COMPLAINTS VENDORS*
Aris Global
ComplianceQuest
isoTracker (Lenox Hill Ltd.)
NetRegulus (PTC)
Q-Pulse (Ideagen Plc.)
Velocity Software
Windchill Quality Suite (PTC)

Sponsored by
TIME & SATISFACTION WITH PRODUCT QUALITY
COMPLAINTS SYSTEM
TIME SATISFACTION
4%
9%
26%
34%
27%
11.4%
21.6%
8.1%
5.1%
7.0%

Sponsored by
2.2%
6.2%
4.0%
On-Premise
3rd Party Hosted
PRODUCT QUALITY COMPLAINTS SYSTEM
2.8%
0.3%1.4%

Sponsored by
COMPARISON OF PRODUCT QUALITY
COMPLAINTS SYSTEM TO 2015
19.0%
3.0%
21.0%
1.0% 0.3%
7.0%
4.0%
10.0%
0.0%
1.0%
2.0%
5.0%
1.3% 2.0%
23.6%
7.0%
10.6%
3.0%
1.3% 1.3% 1.3%
7.0%
1.5%
3.0% 2.6%
10.0%
0.2% 0.7%
0%
5%
10%
15%
20%
25%
2016 2015

Sponsored by
COMPLAINTS - ADVERSE EVENTS
6.2%
24.2%2.8%
1.7%
9.0%
9.6%
1.7%
5.1%
1.7%
2.2%
11.2%
ACE (PSC Software)
Argus (Oracle)
Aris Global
ETQ
MasterControl
Pilgrim
Verse
ZenQMS
Other

Sponsored by
LIST OF OTHER COMPLAINTS - ADVERSE
EVENTS VENDORS*
ComplianceQuest
Safefood 360
Tip Technologies

Sponsored by
TIME & SATISFACTION WITH ADVERSE EVENTS
SYSTEM
TIME SATISFACTION
11.4%
21.6%
8.1%
5.1%
7.0%
2%
10%
28%
33%
27%

Sponsored by
ADVERSE EVENTS SYSTEM
31.0%
1.4%
0.4%
2.5%
32.5%4.3%
7.6%
6.5%
On-Premise
3rd Party Hosted

Sponsored by
COMPARISON OF ADVERSE EVENTS TO 2015
51
18.9%
4.7%
18.5%
1.8%
1.3%
6.9%
0.0%
7.3%
1.3%
0.0% 0.0% 0.0%
3.9%
1.3% 1.7%
21.8%
8.7%
10.8%
1.5%
0.2%
1.2% 1.4%
5.2%
1.0%
2.1%
3.3%
2.3%
8.3%
0.2%
1.0%
0%
5%
10%
15%
20%
25%
2016 2015

52
SectionSponsoredBy
Are you a Vendor that is
not listed in this Report?
Fill out your Profile for
2017 NOW!
Using a system not listed in this
Report? Tell your Vendor!

Sponsored by
DEVIATIONS AND NON-CONFORMANCES
19.4%
4.0%
23.4%
1.1%1.1%
8.6%
4.0%
1.4%
8.6%
1.1%
1.1%
2.5%
1.8% 5.8%
1.8%
2.2%
12.2%
ACE (PSC Software)
AutoSHEQ
Cebos
ETQ
IQS, Inc.
MasterControl
Pilgrim
Q-Pulse (Gael)
SAP
Verse
ZenQMS
Other

Sponsored by
LIST OF OTHER DEVIATIONS AND NON-
CONFORMANCES VENDORS*
Agile PLM (Oracle)
Arena Solutions
Blue Mountain
CAMA Software
ComplianceQuest
JIRA (Atlassian)
Lotus Notes
Montium
Oracle
QMSrs Ltd
Redmine
Rescop
ServiceNow
uniPoint Software

Sponsored by
TIME & SATISFACTION WITH DEVIATIONS AND
NON-CONFORMANCES SYSTEM
TIME SATISFACTION
16.2%
33.1%
14.3%
4.5% 10.2%
4% 11%
24%
33%
28%

Sponsored by
DEVIATIONS/NON-CONFORMANCES SYSTEM
35.0%
4.5%
7.9%
6.0%
On-Premise
3rd Party Hosted
33.8%
1.5%0.4%0.8%
Totally Internal

Sponsored by
COMPARISON OF DEVIATIONS AND NON-
CONFORMANCES TO 2015
17.9%
3.7%
21.6%
1.0%
8.0%
3.7%
1.3%
8.0%
1.0%
2.3% 1.7%
5.3%
1.7% 2.0%
23.9%
8.7%
10.7%
1.4% 2.4%
1.6%
0.4%
7.1%
1.6%
3.4% 1.8%
10.1%
0.2% 0.8%
0%
5%
10%
15%
20%
25%
30%
2016 2015

58
SectionCo-SponsoredBy
SectionCo-SponsoredBy

Sponsored by
DOCUMENT MANAGEMENT
13.0% 2.0%
24.6%
1.3%
2.7%
8.0%
1.0%
4.3%
1.3%
15.9%
1.0%
1.0% 5.0%
2.0%
4.0% 13.0%
ACE (PSC Software)
Cebos
Documentum (EMC)
ETQ
FirstDoc (CSC)
IQS, Inc.
MasterControl
SAP
Verse
ZenQMS
Other

Sponsored by
LIST OF OTHER DOCUMENT MANAGEMENT
VENDORS*
123Compliance
Agile PLM (Oracle)
Arena Solutions
AutoSHEQ
ComplianceQuest
eDOCS (OpenText)
Empower PLM (Omnify Software)
Formpipe.GxP (Formpipe Software AB)
JIRA (Atlassian)
Liquent
Lotus Notes
Montium
NextDocs
Pilgrim Quality Solutions
Q-Pulse (Gael)
Rescop
TRIM Records Management (HP)
uniPoint Software
Veeva

Sponsored by
TIME & SATISFACTION WITH DOCUMENT
MANAGEMENT
TIME SATISFACTION
22.3%
35.2%
10.6%
5.7% 13.6%
2%
7%
23%
34%
34%

Sponsored by
DOCUMENT MANAGEMENT SYSTEM
17.6%2.3%
4.6%
3.1%
On-Premise
3rd Party Hosted
28.8%
46.2%
1.1% 1.9%
1.1%
Totally Internal

Sponsored by
COMPARISON OF DOCUMENT MANAGEMENT
SYSTEM TO 2015
12.7%
2.0%
24.1%
0.3%
1.3% 2.6%
7.8%
4.2%
0.0% 0.0%
1.3%
15.6%
0.7% 1.0% 1.0%
4.9%
2.0%
3.9%
18.4%
6.8%
16.6%
2.6%
0.6%
6.0%
1.4% 1.2% 1.4% 1.4%
0.2%
12.4%
1.8% 1.2% 2.0%
7.4%
0.0%
0.8%
0%
5%
10%
15%
20%
25%
30%
2016 2015

Sponsored by
ENVIRONMENTAL HEALTH & SAFETY (EHS)
30.4%
5.4%
34.5%
8.1%
2.7%
2.0%
16.9%
ACE (PSC Software)
ETQ
SAP
SharePoint
Other

Sponsored by
LIST OF OTHER ENVIRONMENTAL HEALTH &
SAFETY (EHS) VENDORS*
Blue Mountain
DataPipe (Knorr Associates)
ecoLOGIC Systems
Entropy (BSI)
HAZMIN (Logical Technology)
KMI
MSDSonline
QPR Software PLC
SFS Chemical Safety

Sponsored by
TIME & SATISFACTION WITH ENVIRONMENTAL
HEALTH & SAFETY (EHS) SYSTEM
TIME SATISFACTION
9.2%
18.4%
3.4%
3.1%
7.3%
3%
9%
33%
27%
29%

Sponsored by
17.6%2.3%
4.6%
3.1%
On-Premise
3rd Party Hosted
ENVIRONMENTAL HEALTH & SAFETY (EHS) SYSTEM
24.5%
11.9%
0.4%
0.4%
0.4%
Totally Internal

Sponsored by
COMPARISON OF ENVIRONMENTAL HEALTH &
SAFETY (EHS) TO 2015
20.0%
3.6%
22.7%
5.3%
0.4%
1.8% 1.3%
19.8%
5.6%
9.9%
0.6% 0.8% 1.2%
0.0%
0%
5%
10%
15%
20%
25%
2016 2015

Sponsored by
LABORATORY MANAGEMENT (LIMS, ELN, ETC.)
24.7%
8.6%
4.3%
4.3%
11.8%
6.5%
2.2%
3.2%
5.4%
4.3%
2.2%
22.6%
Agilent
Empower (Waters Corp.)
LabWare (Waters)
Lims1 (Ltech Australia Pty Ltd)
SAP
SQL*LIMS
Star LIMS
Thermo Scientific
Other

Sponsored by
LIST OF OTHER LABORATORY MANAGEMENT
VENDORS*
Apollo LIMS (Common Cents Systems)
Blaze LIMS (Blaze Systems)
Clinsys Group
CORE LIMS (Core Informatics)
Labtronic / LABWORKS (PerkinElmer)
Rescop
* Those software vendors with less than a 1% response are not reflected in the chart but are included in this list of other Vendors.

Sponsored by
TIME & SATISFACTION WITH LABORATORY
MANAGEMENT SYSTEM
TIME SATISFACTION
3.8%
10.4%
1.9%
2.7%
6.9%
13%
27%
45%
12%
Poor Average Good Excellent

Sponsored by
LABORATORY MANAGEMENT SYSTEM
17.6%2.3%
4.6%
3.1%
On-Premise
3rd Party Hosted
24.5%
11.9%
0.4%
0.4%
0.4%
Totally Internal

Sponsored by
COMPARISON OF LABORATORY MANAGEMENT
TO 2015
13.7%
4.8%
2.4%
0.6% 0.6%
2.4%
6.5%
0.6%
3.6%
1.2% 1.8%
3.0%
2.4%
1.2%
13.6%
4.9%
1.4%
0.4% 0.2% 0.2%
1.8%
0.6%
3.4%
1.0%
4.9%
3.8%
2.0% 1.4%
0%
2%
4%
6%
8%
10%
12%
14%
16%
2016 2015

Sponsored by
MANUFACTURING EXECUTION SYSTEM (MES)
18.7%
8.8%
2.2%
1.1%
4.4%
3.3%
2.2%
2.2%
3.3%
2.2%
9.9%
41.8%
Manual / Microsoft Office)
Apriso (Dassault Systemes)
Camstar (Siemens)
Epicor
Infor
Oracle
QAD
Rockwell
SAGE
SAP
Other

Sponsored by
LIST OF OTHER MANUFACTURING EXECUTION
SYSTEM VENDORS*
IBS US
JDA
MAPEX Software
Navision (Microsoft)
NetSuite
Werum Software & Systems
Wonderware (Invensys / Schneider Electric)

Sponsored by
TIME & SATISFACTION WITH MANUFACTURING
EXECUTION SYSTEM
TIME SATISFACTION
2.3%
7.3%
2.7%
2.7%
12.0%
3%
13%
44%
37%
4%

Sponsored by
MANUFACTURING EXECUTION SYSTEM
16.6%
1.5%
1.9%
0.0%
On-Premise
3rd Party Hosted
11.6%
11.2%
1.2% 0.0% 0.8%
Totally Internal

Sponsored by
COMPARISON OF MANUFACTURING EXECUTION
SYSTEM TO 2015
10.2%
4.8%
1.2%
0.6%
2.4%
1.8%
1.2% 1.2%
1.8%
1.2%
5.4%
0.6%
0.0%
9.3%
6.7%
0.2%
1.0%
0.4%
1.0%
2.6%
0.6%
1.0%
0.2%
8.3%
1.0% 1.0%
0%
2%
4%
6%
8%
10%
12%
2016 2015

Sponsored by
SECTION SPONSORED BY

Sponsored by
PRODUCT LIFECYCLE MANAGEMENT (PLM)
25.9%
9.9%
4.9%
3.7%
1.2%1.2%
3.7%
13.6%
1.2%
18.5%
8.6%
1.2% 1.2%
4.9%
Agile PLM (Oracle)
Arena PLM
eMatrix/Matrix One (Dassault)
ETQ, Inc.
OnePlace (Eclipse Computing)
PSC Software
SAP
Siemens PLM
Windchill PLM (PTC)
Other

Sponsored by
TIME & SATISFACTION WITH PRODUCT
LIFECYCLE MANAGEMENT SYSTEM
TIME SATISFACTION
4.3%
13.6%
1.2%
6.2%
1%
8%
36%
29%
26%

Sponsored by
PRODUCT LIFECYCLE MANAGEMENT SYSTEM
14.3%
1.6%
3.1%
1.6%
On-Premise
3rd Party Hosted
12.8%
11.2%
1.2%
0.0%
0.0%
Totally Internal

Sponsored by
COMPARISON OF PRODUCT LIFECYCLE
MANAGEMENT TO 2015
12.6%
4.8%
2.4%
1.8% 1.8%
6.6%
9.0%
4.2%
0.6% 0.6% 0.6% 0.6% 0.6%
0.0%
10.6%
5.9%
6.7%
0.4%
0.0%
1.4%
0.0%
6.1%
0.6%
0.2% 0.2%
1.4% 1.4% 1.2%
0%
2%
4%
6%
8%
10%
12%
14%
2016 2015

Sponsored by
STATISTICAL PROCESS CONTROL (SPC) /
PROCESS ANALYTICAL TECHNOLOGY (PAT)
24.8%
5.3%
0.9%
8.0%
2.7%
0.9%
14.2%
26.5%
0.9% 12.4%
Cebos
Infinity QS
ISP Software Solutions
Microsoft Excel*
Minitab
Northwest Analytics (NWA)
PQ Systems
SIMATIC (Siemens)
Synergy (Zontec)
WinSPC (DataNet Quality Systems)
Other
*Due to analytical capabilities in MS Excel,
this has been extracted from Manual/MS
Office into a specific response.
All

Sponsored by
TIME & SATISFACTION WITH SPC/PAT SYSTEM
TIME SATISFACTION
2.7%
10.5%
7.0%
2.3%
8.2%
11%
9%
32%

Sponsored by
INSTALLATION & IMPLEMENTATION OF SPC/PAT
21.9%
1.6%
1.2% 0.4%
On-Premise
3rd Party Hosted
7.8%
0.4%0.4%0.0%
Totally Internal

Sponsored by
COMPARISON OF SPC/PAT TO 2015
13.6%
2.9%
4.4%
1.5%
7.8%
14.6%
0.5% 0.5%
6.7%
3.1%
0.0%
1.4%
3.5%
5.5%
0.8%
0.6%
0%
2%
4%
6%
8%
10%
12%
14%
16%
2016 2015

Sponsored by
SUPPLIER QUALITY
26.4%
2.8%
25.9%7.5%
5.7%
1.4%
5.2%
4.2%
2.4% 4.2%
1.4%
2.8%
9.9%
ACE (PSC Software)
ETQ
IQS, Inc.
MasterControl
SAP
Verse
ZenQMS
Other

Sponsored by
LIST OF OTHER SUPPLIER QUALITY VENDORS*
Ariba
AutoSHEQ (Centurion Quality Management)
ComplianceQuest
Documentum (EMC)
Infor
IQRC
Muddy Boots Software
Oracle
Pilgrim Quality Solutions
QAD
Q-Pulse (Gael)

Sponsored by
TIME & SATISFACTION WITH SUPPLIER QUALITY
TIME SATISFACTION
15.2%
27.3%
7.8%
3.5%
10.5%
4%
8%
33%
28%
27%

Sponsored by
INSTALLATION & IMPLEMENTATION OF SUPPLIER
QUALITY
28.5%
2.7%
6.6%
5.1%
On-Premise
3rd Party Hosted
30.5%
25.4%
0.4% 0.8%
0.0%
Totally Internal
Used a local service provide

Sponsored by
COMPARISON OF SUPPLIER QUALITY TO 2015
25.5%
2.7%
25.0%
7.3%
5.5%
0.0%
1.4%
5.0%
1.1% 1.1% 1.1% 1.1%
4.1%
2.3%
4.1%
1.4%
2.7%
28.1%
8.6%
11.5%
1.4% 1.2% 1.0%
0.2%
3.9%
0.0%
1.0%
0.4%
1.4%
4.9%
0.2%
3.1%
0.0% 1.0%
0%
5%
10%
15%
20%
25%
30%
2016 2015

Sponsored by
TRAINING/LEARNING MANAGEMENT
14.4%
2.7%
25.9%
1.9%
1.5%
6.1%4.2%
1.1%
2.7%
13.3%
1.5%
1.5%
2.3%
1.5%
4.6%
14.8%
ACE (PSC Software)
ComplianceWire (UL Eduneering)
Cornerstone OnDemand
ETQ
IQS, Inc.
IsoTrain (Softek)
MasterControl
Saba
SuccessFactors (SAP)
Verse
ZenQMS
Other

Sponsored by
LIST OF OTHER TRAINING/LEARNING
MANAGEMENT VENDORS*
123Compliance
AutoSHEQ
Cebos
ComplianceQuest
Halogen Software
NextDocs
PeopleSoft (Oracle)
Pilgrim
Plateau (SAP)
Rescop
SumTotal
Taleo (Oracle)
uniPoint Software

Sponsored by
TIME & SATISFACTION WITH
TRAINING/LEARNING MANAGEMENT SYSTEM
TIME SATISFACTION
19.3%
35.0%
11.8%
4.3%
8.3%
6%
10%
26%
32%
25%

Sponsored by
TRAINING/LEARNING MANAGEMENT SYSTEM
30.3%
7.5%
9.1%
7.5%
On-Premise
3rd Party Hosted
29.1%
38.6%
1.6%
1.2%
0.8%
Totally Internal

Sponsored by
INTEGRATION OF TRAINING/LMS WITH QUALITY
OR DOCUMENT MANAGEMENT SYSTEM
0.0% 5.0% 10.0% 15.0% 20.0% 25.0% 30.0%
Other
Manually extract data from our Quality or Document
Management System and enter it again into the
Training/LMS System
Quality or Document Management System is
electronically integrated with our Training/LMS
System
Training Compliance is part of the Quality or
Document Management System functionality
2.4%
11.8%
20.1%
28.3%

Sponsored by
COMPARISON OF TRAINING/LEARNING TO 2015
14.2%
2.6%
25.4%
1.9% 1.5%
6.0%
4.1%
1.1%
2.6%
13.1%
0.4% 0.7%
0.0%
1.5% 1.5%
2.2%
0.4%
1.5%
4.5%
20.7%
10.4%
12.4%
3.5%
0.6%
1.2%
0.2% 0.2%
1.7%
8.7%
1.0% 1.9% 1.5% 1.0%
0.2%
2.1%
1.0%
0.4% 0.8%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
2016 2015

Sponsored by
SAAS / CLOUD BASED SYSTEMS
What percent of your systems are currently cloud based (or SaaS) or planned to be
within the next year?
14.1%
6.4%
7.6%
6.8%
8.8%
5.2%
Less than 10%
Between 11-25%
Between 26-50%
Between 51-75%
Between 76-99%
100% are Cloud based

Sponsored by
COMPARISON OF CLOUD (SAAS) SYSTEMS TO
2015
100
9.2%
14.1%
6.4%
7.6%
6.8%
8.8%
5.2%
21.8%
14.0%
7.8%
5.1%
7.4% 7.6%
8.5%
0%
5%
10%
15%
20%
25%
2016 2015

Sponsored by
SOME SELECTED THOUGHTS TO THE TREND OF
QMS SOFTWARE MOVING TO THE CLOUD
“Easy access, security concerns, private cloud preferred”
“Some people are stuck against it. If you pick your partners correctly, it can be such a positive change” “Uptime statistics are interesting, but more
important is how often they update the software, do they have an organized/compliant process to do so and do they have a help desk that answers
questions in minutes or hours”
“Great option for small companies, but the costs really add up”
“Only concern is ability to access tables to help define custom queries”
“The speed on interaction with application”
“Managing change control risk is a challenge”
“Takes the burden of data backup systems away and makes life easier for IT”
“I prefer this movement provided that the vendor has a firm grasp on software compliance needs”
“From a quality perspective I do not mind where a service is hosted so long as it can be qualified”
“Cloud based system qualification is new and complex. GAMP or FDA do not have very specific guidelines for cloud based software as yet”
“Makes a lot of sense in terms of accessibility and hardware costs. Customer service is very important to the system running effectively”
“Cloud only means another companies servers. Security is still an issue, as is encryption”
“For our company, cloud is the only way to go. We have limited IT resources. We also want all users to be able to use the system at the same time.
Evaluating potential additional usage of cloud computing but moving cautiously”
“Current management is opposed to it”
“It is an excellent concept that works!”
“Risks involved in security of intellectual property are a big concern”
“Security restriction and risk is high for our data types”
101

Sponsored by
BIGGEST CHALLENGE IN IMPLEMENTING QMS
2.0%
2.4%
2.4%
4.0%
5.6%
8.0%
9.2%
9.2%
9.6%
11.2%
12.0%
14.5%
14.9%
18.1%
18.9%
21.7%
0.0% 5.0% 10.0% 15.0% 20.0% 25.0%
Difficulty in rolling out to many locations world-wide
Did not define lean process before automating
Data Management (master, transactional, archived)
Governance and Change Control
Customize too much instead of utilizing out of the box functionality
Integration with company's internal systems
Difficult to configure
Lack of focus from the company (not a priority)
Lack of IT support or IT resource availability during implementation
Lack of business resource availability during implementation
Validation
Requirements harmonization across all Business Units
Cost of implementation
Finding the right Vendor
Cost of licenses / subscription
Cultural adoption (i.e., not user-friendly, manual to electronic, legacy to new
system, individual vs. harmonized requirements)
What else?
• Acceptance
• Data migration
• Upgrades cause more issues
• Working with systems vendor
preferred supplier
• Security and encryption
• Lack of keeping up with latest versions
• Duration
• Training and support for remote users
• Company politics

Sponsored by
BIGGEST TECHNOLOGY TREND IMPACTING QMS
0% 2% 4% 6% 8% 10% 12% 14% 16% 18%
3D Printing
Internet of Things (IoT)
Intelligent Automation / Smart Machines
Other
Information of Everything
Big Data Analytics
Digital Transformation
Mobility
What else?
• Cloud
• Electronic batch records
• Serialization of pharma products
• Electronic archiving
• Security

Sponsored by
RESOURCE SKILLS NEEDED FOR QMS SYSTEMS FUTURE SUCCESS
With the change of baby-boomers leaving prominent Quality
jobs and Millenials coming on-board eager to drive to a new
standard, some skills need to be kept at a premium level.
Although some of baby-boomers still need better computer
skills, this won’t be a problem for Millenials growing up in
the age of computers, tablets, smart phones and the
internet. Some of the skills needed is not a surprise as these
exist today: business process/products and regulatory
requirements for Quality, Lean Six Sigma to keep operations
efficient without additional cost. But most of all are
resources that can be change agents and cultural adoption
leaders to help the organization adopt and embrace the new
technologies that are affecting Quality now and in the
future.
Good trainers who know how to train will be needed to be
coupled with business SMEs making sure that the
investment in rolling out of new system is being understood
and used properly. With new technology, companies will
need resources who are critical thinkers and have the ability
to correctly recognize, prioritize and control risk. Lastly, with
all the technology changes, IT needs a closer relationship
with quality / business by having the technical know-how but
with business acumen.
• Business Process Engineering
• Training, Certified Trainers and Communication
• Data Management
• Computer Literacy
• Lean Six Sigma
• World-wide regulatory knowledge in
manufacturing, supply and post-market
surveillance
• System Admin skills beyond one person
• Change Agents, Cultural Adoption Leaders
• Risk Assessment and Impact
• Technical Know-How with Business Acumen
• Compliance Literacy
• Business Analysts with Critical Thinking to
Recognize, Prioritize and Control Risk
• Validation
• Facilitation across IT and business and across
various business units
• Dedicated team for implementations and updates
• Facilitate standardization across entire enterprise

Sponsored by
SELECTED PARTICIPANT’S COMMENTS IN GENERAL
“Much needed in our world of metrics”
“Have external auditors use ONE system”
“Managing the validation and qualification aspect of the implementation is key”
“The cultural change going from a paper-based to an electronic QMS is the toughest
part of implementation”
“FDA is slow to adopt new technologies”
“Once working properly, they have saved us so much time now”
“Continuous usage gives us long term benefits to the company”
“Electronic version should be mandatory”
“Always lean before you automate, begin with the end in mind - define what do you
want delivered from the system (reports, metrics, etc.)”
“Real time data is more and more the trend”
“Provide comprehensive training to everyone”
“Need a standardized approach to validation within industry”

Sponsored by
RECOMMENDATIONS FOR 2017 SURVEY
• Risk Management (new)
• Electronic Batch / DHR Records (new)
• Add Customer Service related question(s) to each category
• Validation (new) and add related questions to each category
• Add Mobility related questions to each category
• Which regulations have the most impact to QMS software*
• Add Security and privacy of data related questions to each category
• IoT*
If you have other ideas for next year’s survey, please take our very quick
Survey on Ideas Now! Thanks.
106
* Will take this under consideration but difficult when going across multiple industries or complex ideas.

107
GoldSponsor
GoldSponsor

Sponsored by
Arena Solutions
989 E. Hillsdale Blvd, Suite 250
Foster City, CA 94404 USA
Arena invented cloud PLM. Its holistic suite of PLM, supply chain and QMS
solutions enables innovative OEMs with complex electronics to manage their
BOMs, facilitate engineering change orders and speed prototyping to improve
margins and collapse time to market. Arena has been ranked a Top 10 PLM
provider and won the coveted Design News Golden Mousetrap Award in 2016.
Contact: Umesh Malhotra
E-Mail: sales@arenasolutions.com
Phone: +1 877 937 1433
Website: www.arenasolutions.com
Facts:
Number of employees: 51-200
Years in Business, Since: 2000
Annual Revenue: Privately Held
Geographic Regions: All
Primary Industries: Automotive, Biotechnology, Computer Hardware, Software,
Networking, Consumer Electronics, Goods, Services, Electrical & Electronic
Manufacturing, Industrial Automation, Machinery, Medical Device, Oil, Gas,
Renewables & Energy, Pharmaceuticals, Plastics, Railroad Manufacturing,
Semiconductors, Telecommunications, Transportation/Trucking/Railroad
Solutions Offered: Adverse Events, Audit Management (Internal/External),
Calibration & Maintenance, Management, CAPA Management, Change
Control Management, Complaints (Product Quality, Technical), Document
Management, EHS (Environmental, Health & Safety) Management,
Exception Management (deviations, nonconformances), Laboratory
Management, PLM, SPC/PAT, Supplier Quality Management, Training
Management
Are you U.S. FDA 21 CFR Part 11 / EU DIR: YES
License Type: Cloud/SaaS Multi-Tenant
Cognizant MedVantage
6330 South 3000 East, Suite 200
Salt Lake City, Utah 84121
MedVantage from Cognizant, is a cloud-based solution for Medical Device
Enterprise- built on Force.com and Service Cloud Platform that helps Medical
device Industry for seamless Product Recall/Repair Management Process and
ensures regulatory compliance (GxP, CAPA, FDA 3500A Med Watch, 21 CFR
820, 821 and Part 803) and Post installation field services management.
Contact: GowriShankar Vembu
E-Mail: GowriShankar.Vembu@cognizant.com
Phone: +1 408 306 7130
Website: www.cognizant.com/medvantageercontrol.com
Facts:
Number of employees: 5000+
Annual Revenue: 1B+
Geographic Regions: Asia Pac, Europe, Middle East, North America
Primary Industries: Medical Device
Solutions Offered: Adverse Events, CAPA, Complaints, Deviations and
Nonconformances, Supplier Quality
License Type: Cloud Multi-tenant Subscription

Sponsored by
EtQ, Inc.
399 Conklin Street, Suite 208
Farmingdale, NY 11735 USA
EtQ's flexible platform has been the foundation for automating critical compliance
solutions for over 20 years. Whether you are looking for an enterprise solution,
mid-market solution, or you're an individual contributor, EtQ truly has a solution
for every company in the world. The result is a set of solutions for all market types
residing on a common, proven and strong compliance platform technology. This
means that regardless of size, scope, or investment, EtQ has a product for you.
Our product family consists of EtQ Reliance for Enterprise, Verse Solutions for
SMB, and traqpath - our free compliance event and CAPA tracking app for mobile
and Web.
Contact: Timothy Lozier
E-Mail: info@etq.com
Phone: +1 516 293 0949
Website: www.etq.com
Facts:
Primary Industries: All
Solutions Offered: Adverse Events, Audit, Calibration & Maintenance, CAPA,
Change Control, Complaints (Product Quality, Technical), Deviations and
Nonconformances, Document Management, EHS, PLM, Supplier Quality,
Training
Certifications: ISO 9001, ISO 27001
License Type: On-Premise, Cloud Single-tenant subscription, Cloud Multi-tenant
Subscription
CyberMetrics - Bronze
1523 W. Whispering Wind Drive, Suite 100
Phoenix, AZ 85085
CyberMetrics Corporation delivers world-class, auditor-recommended software
solutions for calibration management and maintenance management that are
flexible, scalable and easy to implement, manage and use. Over 12,000
facilities worldwide choose our software solutions to assure standards
compliance, maximize efficiency and reduce costs.
Contact: Shana Jordan
E-Mail: sjordan@cybermetrics.com
Phone: 480-371-2333
Website: http://www.cybermetrics.com
Facts:
Primary Industries: Automotive, Biotechnology, Chemicals, Consumer
Electronics, Goods, Services, Cosmetics, Defense & Space/Military,
Electrical & Electronic Manufacturing, Food & Beverages, Gambling &
Casinos, Glass, Ceramics, Plastics& Concrete, Hospital & Health Care,
Industrial Automation, Machinery, Medical Device, Mining & Metals, Oil,
Gas, Renewables & Energy, Packaging & Containers, Paper & Forest
Products, Pharmaceuticals, Transportation
Solutions Offered: Calibration & Maintenance, Document Management,
Supplier Quality Management, Training
Certifications: ISO 9001, ISO 13485, ISO/TS 16949, ISO/IEC 17025, AS 9100
Subscription, 3rd Party Hosted License

Sponsored by
Formpipe Life Science
13 Poplars Court
Lenton Lane
Nottingham N G7 2RR UK
The Formpipe Life Science division simplifies complex process and technology
environments to deliver customers’ quality and compliance goals within the relevant
regulatory framework(s). This is achieved through a combination of Consultancy to ‘Get
Compliant’, and Products and Consultancy to ‘Stay Compliant.’ Both are delivered by
experts from the sector. A suite of products addresses the compliance and quality needs of
Life Science organisations, all of which are designed to be easy to use, increase efficiency
and reduce costs across businesses with 50-25,000 users. All Life Science products are
managed using a bespoke internal Quality Management System and are supported and
maintained by a dedicated global team. The company's software helps improve efficiency,
cut costs and reduce risk exposure.
Contact: Keith Williams
Email: keith.williams@formpipe.com
Phone: +44 115 924 8475
Website: www.formpipe.com/lifescience
Facts:
Annual Revenue: 1-25M
Geographic Regions: North America, Europe, Asia Pac
Primary Industries: Hospital & Health Care, Information Technology & Services,
Medical Device, Pharmaceuticals, Cosmetics, Chemicals, Biotechnology
Solutions Offered: Training, Supplier Quality Management, Manufacturing
Execution (MES), Laboratory Management (LIMS, LES), Deviations and
nonconformances, Document Management, Change Control, CAPA, Audit
Are you FDA 21 CFR Part 11/ EU DIR Compliant? Yes
License Type: On-Premise (in-house), Cloud (single tenant) Subscription, Cloud
(multi-tenant) Subscription
MasterControl
6330 South 3000 East, Suite 200
Salt Lake City, Utah 84121
MasterControl Inc. is a committed team of quality, regulatory and software
experts who work to empower regulated companies to get their products to
market faster. MasterControl's quality management software solutions reduce
overall costs, increase efficiency and accelerate compliance, creating a
significant competitive advantage for customers. MasterControl's complete
quality management solution is designed for easy implementation, validation
and use, continually improving on the promise of Compliance Accelerated.
Contact: Matt Lowe
E-Mail: mlowe@mastercontrol.com
Phone: 801-942-4000
Website: www.mastercontrol.com
Facts:
Primary Industries: Automotive, Biotechnology, Chemicals, Consumer
Electronics, Goods, Services, Electrical & Electronic Manufacturing, Food
& Beverages, Hospital & Health Care, Logistics, Warehouse & Supply
Chain, Medical Device, Oil/Gas/Renewables & Energy, Pharmaceuticals
Solutions Offered: Adverse Events, Audit, Calibration & Maintenance, CAPA,
Change Control, Complaints, Document Management, EHS, Deviations
and Nonconformances, Supplier Quality, Training
Certifications: ISO 9001
License Type: On-Premise, Cloud Multi-tenant Subscription

Sponsored by
Motto Systems PVT LTD - Bronze
SAMRIDHI VASYAM, JAI HIND COLONY, MADHAPUR
HYDERABAD, TELENGANA 500081 INDIA
Motto Systems’ is an organization that has made pioneering strides in providing
top-class enterprise quality management solutions (EQMS) to Life Sciences’
companies. GMPPro is a end to end quality compliance tool. Driven by innovation
and backed by a qualified team of GMP domain and IT experts. We offer complete
Warehouse, Production, QA, QC & Maintenance modules.
Contact: K RAJGOPA
E-Mail: raj@mottosys.com
Phone: +9553444478
Website: www.MottoSys.Com
Facts:
Annual Revenue: 1-25M
Geographic Regions: Asia Pac, Europe, Latin America, Middle East, North
America
Primary Industries: Chemicals, Food & Beverages, Packaging & Containers,
Pharmaceuticals
Solutions Offered: Audit, Calibration & Maintenance, CAPA, Change Control,
Complaints, Document Management, Deviations and Nonconformances,
Laboratory Management (LIMS, LES), Product Lifecycle (PLM), Supplier
Quality Management
Certifications: ISO 9001, ISO 27001
License Type: On-Premise, Cloud Single-tenant subscription
Qualio
156 2nd St.
San Francisco, CA 94105 USA
Qualio helps life-saving technologies get to market faster through making Quality
a competitive advantage. A simple dashboard makes it easy to manage all the
daily activities for quality teams. Real-time reporting puts you in control so you can
be audit ready at all times, and built-in QA/RA best practices makes it easy to
build, maintain and scale your quality program. With customers all over the word
from early stage medical devices to public biotechnology organizations, Qualio is a
perfect partner to help your company scale. And with offices in California, Ireland
and Poland – no matter where you are we’ve got you covered.
Contact USA: Colin Moore
Contact Ireland: Damien Barry
E-Mail: info@qualio.com
Phone: +1 855 203 2010 USA
Phone: +353 1 697 1522 Ireland
Website: www.qualio.com
Facts:
Geographic Regions: Asia Pac, Europe, North America
Primary Industries: Biotechnology, Medical Device, Pharmaceuticals
Solutions Offered: CAPA, Change Control, Complaints (Product Quality, Technical),
Deviations and Nonconformances, Document Management, Training

Sponsored by
SoftExpert Software
201 South Biscayne Blvd. Suite, 1200
Miami/FL USA
SoftExpert is a market leader in software and services for enterprise-wide
business process improvement and compliance management, providing the
most comprehensive application suite to empower organizations to increase
business performance at all levels and to maximize industry-mandated
compliance and corporate governance programs. Along with its extensive
network of international resellers, SoftExpert also provides hosting,
implementation, post-sales support and validation services to ensure that
customers realize the maximum value from their investments.
E-Mail: sales@softexpert.com
Phone: 1-646-504-7910
Website: www.softexpert.com
Facts:
Primary Industries: All
Solutions Offered: Audit, Calibration & Maintenance, CAPA, Change Control,
Complaints (Product Quality, Technical), Deviations and
Nonconformances, Document Management, EHS, Laboratory
Management, PLM, SPC/PAT, Supplier Quality, Training
Certifications: ISO 9001, ISO 13485, ISO 14000, ISO 27001
Subscription, 3rd Party Hosted License
Traction Software
245 Waterman St., Suite 504
Providence, RI 02906
Traction TeamPage is collaboration software geared towards addressing a
spectrum of ISO related use cases ranging from documentation and management
team meetings/reporting to tracking quality issues and executing on improvement
projects.
Contact: Jordan Frank
E-Mail: jfrank@tractionsoftware.com
Phone: 1-401-487-2268
Website: www.tractionsoftware.com
Facts:
Geographic Regions: Africa, Asia Pac, Europe, North America
Primary Industries: Automotive, Banking, Biotechnology, Chemicals, Computer
Hardware/Software/Networking, Construction, Consumer Electronics/
Goods/Services, Defense & Space/Military, Electrical & Electronic
Manufacturing, Environmental/Facilities Services, Financial Services, Food
& Beverages, Hospital & Health Care, Industrial Automation, Information
Technology & Services, Logistics/Warehouse & Supply Chain, Medical
Device, Mining & Metals, Oil/Gas/Renewables & Energy, Pharmaceuticals,
Semiconductors, Wholesale
Solutions Offered: Adverse Events, Calibration & Maintenance, CAPA, Change
Control, Complaints, Document Management, Deviations and
Nonconformances, Training
License Type: On-Premise, Cloud Single-tenant subscription

Sponsored by
Want to be a sponsor for the
2017 QMS Vendor Software
Benchmark Report?
ZenQMS
128 Front Street
Conshohocken, PA 18925 USA
ZenQMS develops amazing quality management software for the whole
enterprise. Our cloud-based platform, which includes modules for Document
Management, Issue/CAPA, Training, Audits & Supplier Management, offers
companies a tremendous opportunity to improve quality compliance and save
money.
Contact: Jeff Thomas
E-Mail: hello@zenqms.com
Phone: +1 888 280 1433
Website: www.ZenQMS.com
Facts:
Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East,
North America
Primary Industries: Biotechnology, Chemicals, Cosmetics, Food & Beverage,
Hospital & Healthcare, Medical Device, Pharmaceuticals
Solutions Offered: CAPA, Change Control, Complaints (Product Quality, Technical),
Document Management, Training

2016 Quality Management System Vendor Software Benchmark Report

2016 Quality Management System Vendor Software Benchmark Report

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