The State of Digital

Quality Maturity
in Pharma
and Medtech
 Research Report

Executive Summary
Quality trailblazers in the pharmaceutical, medical
device, biotech, biologics, and other life sciences
industries are constantly adapting to changes in their
industries, regulations, and technology.

Technology in particular has an annoying habit of changing right when you think
you’ve got it right. That also makes it difficult to know where you stand digitally
in relation to your competitors. To help you understand how you compare to your
peers and how to become more digitally mature, we conducted research into
digitization in the life sciences.

This edge-of-your-seat report covers where the industry stands, the challenges
that quality professionals face, and the role technology plays in their daily work. We
chatted with 152 quality professionals in the life sciences about how they approach
quality management and their progress in their digital transformation journey. Of
course, trying to measure progress meant we had to define different stages of that
journey, which we did in a quality maturity model. This model has four tiers: manual,
digital, connected, and intelligent. Your peers determined where they fell in the model,
where they thought the industry was, what might hold them back, and what’s driving
them forward.

Some key takeaways from the research include:

1 Even though 85% of companies have a QMS, most of them are missing the
benefits that come from a fully implemented QMS.

2 The larger a company is, the more likely it is to prioritize digital

transformation.

3 The number one driver for digitization is that digital maturity is a

competitive advantage, as cited by 58% of respondents.

4 Only 42% of respondents have a formal quality digital transformation plan.

The remaining 58% have ad hoc or informal plans, making their digital
transformation journey more difficult than it needs to be.

This report will help you understand the current state of digital transformation in the
life sciences industry. You’ll learn more about the quality maturity model, the benefits
of each tier, and the steps needed to stay ahead of your competition.

MasterControl is poised to help your company with its digital transformation by

partnering with you to implement the best solution while further developing the
capabilities you need. We’re constantly innovating to bring more value to our users.
We’ve done this with tools specifically designed to help you with software validation,
creating procedures, analyzing your data, and more.

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 Research Report

1.
Research Overview
We spoke with 152 quality leaders in the life sciences,
including those working in pharmaceuticals, medical
devices, biotech, and biologics. These companies are
based globally and represent a mix of job levels from
managers to executives.

We spoke with representatives from companies that have fewer than 500 employees
to those with over 5,000. Annual revenue among the companies also varied greatly,
from less than $10 million to over $1 billion.

Research included both quantitative surveys and in-depth qualitative interviews,

which provided more detail and context. Our goal in conducting this research was to
better understand where the industry is when it comes to digital transformation, any
barriers to digital transformation, and how we can help you break down those barriers.

Respondent Position

51% 30% 19%

Director Manager Executive

Respondent Specific Role

49% 20% 17% 11% 3%

Quality Quality Quality Other Continuous
Assurance Control Engineering Improvement

Company Industry

44% 23% 19% 8% 6%

Pharmaceuticals Medical Devices Biotech Biologics Other

Company Annual Revenue

27% 31% 22% 20%

> $1B $100M-$1B $10M-$100M < $10M

Company Global Employees

39.5% 14.5% 23% 23%

1-500 500-1,000 1,000-5,000 >5,000

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2.
Market Context
If you don’t know us, MasterControl is the #1 quality
management system (QMS) for the life sciences
and has been an industry leader for over 25 years.
We predate 21 CFR Part 11 (and Y2K). We remember
FOR
when getting signatures for your SOP meant physically
running around and talking to people. In person. Yikes.

Fortunately, we don’t have to do that anymore. We’ve seen quality management

evolve from something largely conducted on paper to a field that involves artificial
intelligence (AI) and machine learning (ML). We see some companies that have gone
full steam ahead into the digital age and invested in multiple enterprise systems.
Others are still living in the ‘90s and continue to rely on paper. Even taking this
into consideration, the industry as a whole is moving forward, increasingly using
technology and intending to become more connected over time.

Increased digitization is commonly referenced as Industry 4.0 or, in the quality

department, Quality 4.0. All these terms basically amount to the same thing —
using AI/ML, blockchain, Internet of Things (IoT) technologies, etc. to improve
quality. While technology is an important part of Quality 4.0, replacing employees
with machines isn’t the answer. Human involvement in quality is still essential.
That’s why at MasterControl we design our products to help users improve quality
by automating tedious and/or repetitive tasks so humans can focus on more
important things. Augmenting humans with technology is the best approach to
Industry 4.0, Quality 4.0, and other associated buzzwords.

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 Research Report

We formally researched the pain points, objectives, and drivers of digital

transformation initiatives. We spoke with quality leaders across the life sciences
industry that work for a range of company sizes. Over half of these leaders said
digital transformation was a high priority or the highest priority at their company.
The importance of digitization did correlate to the size of a company with
66% of large companies giving it high priority versus 43% of small companies.
A company’s industry seemed to be less of a factor in determining priority.

Prioritization of Digital Initiatives Prioritization of Digital Initiatives

by Industry by Company Size

100
High/Highest Priority 49% 52% 54% 55% 43% 44% 55% 61%

One of Many Priorities

75

Not a Priority/Low Priority

50 50% 50%
46% 43% 46% 45% 43%
39%
25

5% 5% 7% 6%
2%
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If digital transformation is a high priority for so many companies, you would expect
that to be reflected in the findings. And, to a point, it is because 85% of organizations
have a digital QMS. But not every QMS is the same and not every company is using
theirs to its full potential. A QMS isn’t directly tied to how many digital systems a
company has or how interconnected they are. You can technically even have a QMS
that entirely runs on paper, though most of the time when we use the term, we’re
referring to software. A better indication of digital maturity is the number of enterprise
systems that are connected to a digital QMS and the number of quality processes that
are completely digital. With 85% having a digital QMS, you’d expect that most of the
pain points associated with manual and disconnected systems would appear among
that remaining 15%. You’d be wrong.

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Most Common Manual/Paper-Based Processes

Quality Pain Points 32%

Time-Consuming Audits/Inspections
24%

High Cost of Quality

23%

Limited Data Visibility

22%

All responses about quality management pain points surpass that 15% mark,
so even companies that have a digital QMS are experiencing these pains. The biggest
pain point was manual or paper-based processes, with 32% of respondents ranking
it as very significant in their organizations. Version control alone explains why this
is such a problem. If you’ve ever had to track down signatures for a document, track
controlled copies, or read a coworker’s handwriting, you feel the respondents’ pain.

Speaking of paper pains — how about finding the most recent version of a document
for an audit or inspection? Audits and inspections were a significant pain point for
24% of respondents. That’s not terribly surprising if you have to comb through filing
cabinets to find your documents. The process is much less harrowing when you can
do a quick search in an electronic system.

State of QMS State of QMS

Implementation Implementation

7% 7%
In the process In the process
of implementing of implementing

29% 33%
33% Fully implemented 29% Partially
at all sites Fully implemented implemented
Partially
implemented at all sites

31% 31%
Fully implemented Fully implemented
at some sites at some sites

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3.
State of QMS Adoption
What do you think of when you read that 85% of
organizations have a QMS? You might expect that if
a company went through the trouble of purchasing
a QMS they’d be using it. And to get the most out of
the investment, they must be using it across all sites.
Right? Well ... reality is a bit more disappointing.

Of respondents that have a QMS, there’s a pretty even split between those who
have fully implemented at all sites, fully implemented at some sites, and partially
implemented. This goes a long way toward explaining why those pesky pain points
State of QMS
persist, even for those who have a QMS.
Implementation
When it comes to those who don’t have a QMS, 43% are looking for one, but still
haven’t found what they’re looking for. Only 17% don’t think a QMS is necessary
7% while another 17% have developed their own QMS. The remaining 9% feel they
In the process can’t justify the cost. While quality and a QMS should be top of mind for every life
of implementing
sciences company, one of our respondents pointed out that sometimes quality
% 33% isn’t a priority until something goes wrong and the powers that be then realize it
ed 29% Partially
es Fully implemented implemented presents a compliance issue.
at all sites

31% Similarly, when everything’s going well, it can be difficult to convince executives
Fully implemented
at some sites
that digital transformation is necessary. When it comes to what holds companies
back, one respondent said a common attitude is, “Well, we’re hitting our numbers.
We’re good. Why spend extra money when our margins are great?” Things might
seem fine at the moment, but that attitude ignores the fact that with constant
advancement, other companies are investing and strengthening their market
position to become more competitive. Additionally, what works now probably
won’t work in five or ten years. Companies that have a long-term strategy realize
Reasons for the time to invest in solutions for the future is now.
Not Having a QMS
On the broader topic of digitization, we asked respondents how they think different
levels of their organization feel about digitizing. Most respondents thought that
9% executives and managers have positive sentiment toward digitizing, but only 41%
Too expensive felt that operators and technicians have positive sentiment about it. That's not
17% to say that operators and technicians have dug in their heels and are refusing to
Homegrown 43% budge. Only 2% thought this group was directly opposed to digitization.
QMS meets Currently
needs looking for
QMS
Regardless of the lower perceived positivity for operators and technicians,
17% digitization brings positive changes to all levels of an organization. Operators and
Not needed
technicians can look forward to reducing human error — in some cases eliminating
it altogether. One MasterControl customer found that after implementing systems
for quality and manufacturing, they reduced data entry errors by 100%. The
level of control presented by a digital QMS makes it easy to get it right the
first time. This also means tasks can be completed faster and there are less
redundancies in the quality system.

60
57%
53%
50
47% 46%
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 Research Report

Managers can also look forward to those efficiencies and improved workflows.
One respondent, commenting on the benefits of a digital QMS, said, “With its advanced
capabilities, it has helped us maintain quality and take all corrective actions on time.”
This makes things easier on a day-to-day basis, but also makes it easier for managers
to track key performance indicators (KPIs) and provides more reliable metrics when
multiple systems are connected and can exchange data with one another.

At the executive level, KPIs are important and can inform strategic business decisions
to improve operations. With disconnected or paper-based systems, these decisions
are based on quarterly reports that someone has compiled manually, which makes
them prone to human error. By the time the report is presented to an executive, the
Reasons for Reasons
information is past for
its expiration date. Digital systems provide more accurate data
Not Having a QMS Not Having
that can be accessed in a near
QMS real time for better decision-making.

These aren’t futuristic benefits. They’re benefits your company could be using now
9% 9%systems. It’s important to note that even if you use digital
with connected quality
Too expensive Too expensive
systems, not all systems can exchange information with each other. Today’s quality
17% management17% software is more sophisticated and allows integrations between
Homegrown 43% Homegrown 43%
QMS meets Currently systems, leading to connected data
QMS meets and the ability to harness it so you can make
Currently
looking for
needs
QMS
needs
data-based decisions instead oflooking
ones for
QMS
based on your gut feeling.

17% 17%
A good example Not of this is quality event management (QEM), which only 57% of
Not needed needed
respondents said is fully digital in their companies. And the numbers just go downhill
from there. Document management and change control come in at 53% being fully
digital, and training comes in at 47%.

Fully Digital vs.

Fully Manual Processes 60
57%
Comparison between companies
53%
that have completely digitized
these quality processes and those
50
47% 46%
who still use manual processes
to complete them.
40
37%
5%
34%
Fully Digital 32%
Fully Manual 30

20%
20
17%
12% 13%
11%
10 8%
6%

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45
MasterControl's
Validation Excellence Tool
lets customers validate
in 45 minutes
1 You 2 might think “simple” is hardly the word
1 2
Research Report
On the opposite end of the spectrum, we asked about processes that are still fully
manual. When it comes to batch review and release, 20% of respondents said their
process is fully manual and audit prep came in second at 17%. The commonality here
seems to be that the more variable and situation-based a process is, the less likely it is
that an organization has completely digitized it.
That doesn’t mean you shouldn’t digitize those processes. On the contrary,
getting ahead of the digital curve gives you the process efficiency and competitive
advantage mentioned above. Quite frankly, the only manual thing in your life
should be your car’s transmission.
The fact that 85% of companies have a QMS, but the numbers for fully digitized
processes are much lower illustrates the fact that there’s a gap between how
connected companies think they are and how connected they actually are. That’s
understandable. The first step is admitting you have a problem. And part of that
problem can be looking for a quick fix, i.e., if we buy digital systems, we’ll be digitized.
“Digitizing” requires much more than buying a QMS or any other software. It’s
more than even fully implementing that QMS at every site. Digitizing is a journey
that you never quite finish. That’s because technology is always advancing. No
system is so advanced that it will never need to be updated. Vendors should
be partners in your digital transformation and offer solutions that grow with
you. That way, keeping up with advances in technology is a simple matter of an
upgrade as opposed to switching to a new vendor.
3 to describe an upgrade when validation
4
is involved. But with MasterControl’s Validation Excellence Tool (VxT), simple is the
perfect word. We designed VxT to shorten and simplify validation. Now, the validation
for an upgrade takes an average of 45 minutes for our customers — making an ongoing
partnership with a vendor both appealing and practical. And before you ask, yes, this
tool has gone through the grind of a regulatory inspection and passed.
3 4
1 2 3 49
in 45 minutes

Research Report

4.
Quality Management
Maturity Model
1 2 3 4

As part of our research, we introduced respondents

to a quality management maturity model to help them
assess where they are and how long it might take their
organizations to get to the next tier.

1 2 3 4

Manual Digital Connected Intelligent

We use manual processes We have digitized our We have a cloud-based
and paper-based quality core processes and core QMS that has enabled
documentation. documentation. my company to create
an API-enabled approach
to connecting the entire
quality life cycle.
1 2
We have taken a data-
centric approach to
connect our product and
process data. We apply
AI applications to power
planning, resourcing,
3 quality, productivity,
4 and
cost transitions.

Capabilities Capabilities Capabilities Capabilities

· Paper-based, hybrid, or · Configurable, cloud- · Unified quality data · Intelligent decisioning

homegrown. based QMS. layer. support.
· “Paper on glass” — · Integrated documents, · Connected product · Predictive risk
scanning paper forms training, and QEM. life cycle. analysis.
that become uneditable
digital documents.

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 Research Report

45
MasterControl's Manual
1 2 3 4
Validation Excellence Tool
lets customers validate The manual tier is basically the ‘90s — it involves paper-based processes, but also
in 45 minutes such cutting-edge technology as scanners. The use of computers in and of itself isn’t
enough to get a company out of the manual tier. The lack of connectivity, inability to
automatically gather data, and reliance on printing out and storing paper documents
are what places a company in this tier. An example of this would be a company that
prints out standard operating procedures (SOPs) and stores them in binders. The only
way to send these documents electronically is to scan them first.

There are many drawbacks to this approach. In the above scenario, version control
presents a problem. This also means that audits and inspections are a problem,
especially if they are conducted remotely. The main benefit of manual systems is that
they’re easy to start. Picking up a piece of paper1 or opening a Word document
2 4 on a 3
1 2 3
computer is an easy way to start writing an SOP. The benefits end there.

Dealing with quality issues as they arise leads to a piecemeal quality “management”
system that has been cobbled together without a larger plan in mind. This is what
happened to one of the respondents, and the flaws in this type of QMS become readily
apparent when a company grows. “Our QMS is homegrown, which we are working to
change as we move from a small to midsized organization.” It takes more time initially
to plan out and implement a more advanced QMS, but when you start with a scalable
QMS, company growth isn’t a problem.

1 2
Digital 3 4
Digital might be a small step in the maturity model, but it’s a giant leap for a company.
In this tier, processes and documentation have all been digitized (and that doesn’t
mean everything’s kept and maintained in Microsoft Word). Companies in this tier use
a purpose-built digital QMS that connects most of their quality processes, including
documents, training, audit, and quality event management (QEM). Many solutions on
the market today fall into this category.

Compared to manual, digital requires more of an investment upfront, but

organizations quickly recoup that investment based on how much time it saves.
When you’ve connected all quality processes, you don’t have to manually
transcribe data from a quality event into a corrective action/preventive action
(CAPA) form.1 This saves time and2 eliminates any human 3
error that might happen
4
when copying data. The digital tier also gives companies the benefit of automation.
In the manual tier, updating an SOP and sending out training is much more
complicated than it sounds.

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Updating an SOP: Manual Tier Digital Tier

A Tale of Two Tiers
1 Update the SOP. 1 Update the SOP.

2 Look up who needs to be trained.

3 Send out training tasks.

4 Send out reminders

(repeat as needed).

5 Update training records.

The employee updates the SOP, looks up who needs to be trained on the updates,
sends out a training task, possibly sends out two or three reminders to complete the
training task, and updates training records when it’s finally complete. This exact same
process in a digital system has one step — update the SOP. That update automatically
triggers the remaining steps at a global level in the system, which frees up the
employee to do less frustrating things than enforce training.

MasterControl can help you progress in your digital transformation. Many of our
customers start their digital journey with their documents and training processes.
We offer more solutions than documents and training, but this is where people
tend to start. When you collaborate on documents in MasterControl, there’s no
need to physically chase people down for their signatures. Once you have approval,
version control is automatic. Only the most recent version of a document can be
accessed, and a complete audit trail tells you who made what changes when.
When your employees need to be trained on documents, the training component of
MasterControl automates the process.

Once you’re comfortable with documents and training, bring in digital QEM.
MasterControl provides a complete connection between different parts of our QMS.
That means if you log a complaint and decide to launch a CAPA, the data is transferred
automatically and doesn’t have to be manually transcribed. You can also quickly update
any SOPs or send out training related to the CAPA from the same system.

Taking these important steps is critical to digitizing your quality operations — but
“digital” is often measured in degrees, with organizations working to extend and
connect digital quality. We often hear this referred to as “digital gaps” — areas like
supplier quality where companies haven’t fully deployed their QMS — or “digital silos”
where their QMS isn’t integrated with other enterprise systems to share data and
automate processes end to end.

These gaps and silos are a common theme in our surveys. “Core processes are
digitized, but these systems generally do not ‘talk’ to each other,” “our company’s
hodgepodge of implementation of various systems [are] varying in integration,” and
“we have an electronic QMS, but it is not fully implemented with other systems,” are
some of the comments we received.

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1 2 3 4
Connected
If the digital tier sounds good, the connected one is even better. As important as a
digital QMS is, it’s not the only enterprise system a company needs to do business. An
enterprise resource planning (ERP) solution, manufacturing execution system (MES),
learning management system (LMS), etc. all play important roles in an organization.
And no single software as a service (SaaS) company provides every solution that a
business might need. That’s where integration comes in. The connected tier is where
the ERP, QMS, MES, and other enterprise systems stop giving each other the silent
treatment and communicate.

1 2 3 4
MasterControl
MasterControl Quality Excellence
Quality Excellence
can integrate and EVENTS:
• New Record
ACTIONS:
• Training Completed
EVENTS:
• New Record
ACTIONS:
• BOM Approved

exchange information • Updated Record • Training Needed • Updated Record • Nonconforming

Materials

with your other ACTIONS:

• Nonconforming
ACTIONS:
• Launch CAPA
enterprise systems. Materials
• Deviations
• Close CAPA

• Approvals
• Training

MES LMS CRM ERP

ACTIONS: EVENTS: ACTIONS: EVENTS:
• Launch Production • New Record • Adverse Event • New Record
• Consume Materials • Updated Record Reported • Updated Record
• Quality Event
ACTIONS: ACTIONS:
• New Training • New BOM
• Training Complete • New Materials

As companies progress in the quality maturity model, their investment increases,

but so does the return on that investment. Just as with the digital tier, the
connected tier requires more time and resources initially, but much less time and
fewer resources in the long run — and it’s scalable. The benefit of connected data
reaches much further than just one department and has broader applications.
When information is visible across all departments, collaboration improves and
bottlenecks can be identified and remedied. For example, automatically exchanging
information between the QMS and LMS is immediate, accurate, and ensures that no
outdated information remains in any of the systems.

23% Less than

think they'll be in half (42%)
the intelligent tier of respondents 13
in the next 5 years, have a formal
see where digital
 Research Report

In a perfect world, all enterprise systems would be integrated. Our research shows
2 that the
3 world isn’t perfect. In our study,
4 the most integrated enterprise system was
laboratory information management system (LIMS), which 54% of respondents have
integrated with their QMS. At the lower end of the spectrum was MES, which only 31%
of companies have integrated with their QMS.

At MasterControl, we can meet more than your QMS needs. We also offer a modern
MES that lets you review by exception and improve right-first-time metrics. Once
you have our QMS and MES working together, you can easily prevent an untrained
operator from completing a task and even train that person on the floor. We also offer
integration services to enable data exchange between your other enterprise systems.

2 3
Intelligent 4

This tier is characterized by using AI/ML to analyze large data sets quickly. The
connected tier brings all data together. However, without harnessing new technology,
companies will not be able to get full value from their data. Once companies have
achieved a unified data layer, they’re in a position to begin training an AI algorithm.
This involves data-based decisions but goes beyond that. In the connected or digital
tiers, companies can use data in their decision-making, but the intelligent tier has
more complete data with analytical and predictive capabilities. This leads to deeper
business intelligence. Once the AI algorithms are fully trained, finding the right areas
to optimize your business becomes even easier. AI can track CAPAs and tell you
whether the corrective action is having the desired effect. If it isn’t, an AI algorithm
can suggest the action that will solve the problem. AI can also predict which trainees
1 are2 most likely to have overdue
3 training. And AI4can even tell you why documents get
rejected and how to get them approved faster. As one respondent put it, “The system
talks to us instead of us only feeding the system.”

At the risk of sounding like a broken record, the intelligent tier requires an investment,
but it pays off. There are enterprise systems that provide AI functionality, but
some companies turn to data scientists and data engineers to help them in their AI
development. AI does take time, but in quality it has enormous potential. Over time, it
can predict quality events before they happen, warn you of potential recalls, and help
you optimize your supply chain to avoid disruption.

That’s not as overwhelming as it sounds. Unless you insist on programming an

algorithm on your own. Then it’s every bit as overwhelming as it sounds. The key
to seeing success with AI in your organization is to invest in software solutions that
provide AI functionality. MasterControl Insights is a business intelligence and data
analytics product that surfaces descriptive, predictive, and prescriptive analytics
based on users’ quality data to help them proactively avoid risk and increase
efficiencies in their quality management. Our approach to AI is more focused on
giving you practical applications that help you in your day-to-day work. We’ll leave the
homicidal AI of a dystopian future to other organizations.

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5.
The Path to Intelligent Quality
Every company should aspire to reaching the
intelligent tier, but depending on where a company is
right now, it might be more of a long-term goal.

Trying to go from the manual tier directly to intelligent is unrealistic. Progressing

from one tier to the next is a more attainable goal. Baby steps are more likely to
get companies some immediate successes on which they can build their digital
transformation. It’s also important to note that there’s a range within each tier. For
example, a company might feel confident they’re in the connected tier simply because
they have some enterprise systems that exchange data — even if the majority of
systems still don’t.

In our research, we found that most companies categorize themselves as either

digital or connected, but also report that their QMS is not fully implemented and, at
the most, only half of their processes are considered fully digital. We spoke to these
professionals about what’s holding their companies back from maturing, what’s
pushing them forward, and what they see as the biggest benefits of the top two tiers.

As previously mentioned, the biggest drawback to moving to another tier is the

upfront cost. This was the most common reason respondents’ companies weren’t
moving forward. For 46%, the cost couldn’t be justified. The second and third most
common reasons involve disruption. Time for transition was a major blocker for 39%
of respondents and general disruption from new tools and systems was a problem
for 33% of respondents. These are all understandable concerns and, depending
on a company’s current situation, might be valid reasons for postponing digital
advancement. However, the pros that push companies toward further digitization are
far more compelling than any objections.

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58% 42% 38%

Most Common
Reasons for
Increasing Maturity
Competitive advantage Organizational IT Merger or acquisition/
in my industry infrastructure requirements new management priorities

34% 32%
Warning letter from Improved connectedness
a regulatory body of my organization

58% 42% 38%

Most Common The number one most common reason for increasing maturity cited by 58% of
Reasons for respondents is that it’s a competitive advantage. The more digitally mature a company
Increasing Maturity is, the faster they can move in all areas of the product life cycle. Being further along on
Competitive
the maturityadvantage Organizational
model helps life sciences IT
companies Merger or acquisition/
deal with regulatory requirements,
in my industry
avoid or better manage recalls,infrastructure requirements
pass audits and newdeal
inspections, and management priorities
with disruption.

39% 39% 38%

Biggest Benefits Surprisingly, only 32% of respondents said increasing maturity was important simply
of the Connected Tier

34% 32%
for improving the connectedness of the organization.

Of all the access

Real-time benefits
toof the connected
quality tier,efficiency
Improved two tied for
andbeing theAutomation
most important
of to
respondents. Real-time
data and insights access to quality data
reduction in errorsand insights, and improved efficiency
processes/workflows
Warning letter from Improved connectedness betweenIt’s
systems
and reduction in errors were both important to 39% of respondents. not surprising
a regulatory body of my organization

32% 26%
that access to quality data and insights were tied with improved efficiency and fewer
errors. Using data to make decisions will lead to improved efficiency and fewer
errors. Fewer errors lead to better data, which leads to better decisions, etc. The two
reinforce and build upon each other, making them mutually beneficial.
Better utilization of human Seamless data transfer
capital/resources across systems

39% 39% 38%

Biggest Benefits
of the Connected Tier

Real-time access to quality Improved efficiency and Automation of

data and insights reduction in errors processes/workflows

36% 36% 28%

Biggest Benefits between systems
of the Intelligent Tier

32%
Minimize human error with
augmented decision support
26%
Enhance processes/
workflows with real-time
Accelerate identification of
the root causes of recurring
Better utilization of human Seamless data
optimization transfer
models deviations with AI
capital/resources across systems

28% 25%
Use advanced risk modeling Improve quality control
to reduce deviations that efficiency with machine
escalate to CAPAs vision

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Biggest Benefits
 39%
Biggest Benefits
of the Connected Tier
Real-time access to quality
data and insights
39%
Improved efficiency and
reduction in errors
38%
Research Report
Automation of
processes/workflows
between systems

32% 26%
The advantages of the intelligent tier were similar, with two benefits tied for the
top spot. Minimizing human error with augmented decision support and enhanced
processes and workflows with real-time optimization models were both important
Better
for 36% utilization of humanTheseSeamless
of respondents. data transfer
are examples of simply taking the benefits of the
capital/resources across systems
connected tier to the next level. For example, connected processes can remove
human error associated with data entry, but augmenting human decisions with AI
removes human error in the form of incorrect assumptions and reasoning. Automating
workflows and processes in the connected tier is important, but by moving to the
intelligent tier those workflows become more efficient. Over time the algorithm learns
where bottlenecks are and how to avoid them.

36% 36% 28%

Biggest Benefits
of the Intelligent Tier

Minimize human error with Enhance processes/ Accelerate identification of

augmented decision support workflows with real-time the root causes of recurring
optimization models deviations with AI

28% 25%
Use advanced risk modeling Improve quality control
to reduce deviations that efficiency with machine
escalate to CAPAs vision

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 • New Training • New BOM
• Training Complete • New Materials

Research Report

Maturity Level of
Respondents' Companies
We asked respondents to rank
where they think their companies
fall in the digital maturity model.
23%
think they'll be in
the intelligent tier
in the next 5 years,
see where
you fall now.
6.
Assessing Your Quality Maturity
We found that most respondents put their
companies in the digital tier. Very few put
themselves in the intelligent tier. Before you
breathe a sigh of relief, we should also point out
that
12% 23.8%
61%of respondents across all tiers 24%think it’s 2%
likely that they will be in the intelligent tier in five
Manual Digital Connected Intelligent
Less than
years. So, the time to move on this is now.
half (42%)
That starts with oftaking
respondents
an honest look at where your company is in its digital
have a formal
transformation. Depending on where your company falls on the spectrum, the
idea of digitizing might be overwhelming. It doesn’t have to be. It starts with
taking a look atdigital
where your company is right now and planning incremental
improvements transformation
from there. Gauging your progress and how to become more
plan in their
digitally mature starts with a series of questions.

Take
Take
Assessment
Assessment organizations.
Maturity Level of Respondents' Companies
We asked respondents to rank where they think their
companies fall in the digital maturity model.

12% 61% 24% 2%

Manual Digital Connected Intelligent

18
 Research Report

How high of a priority is digitizing quality management

processes in your organization?
Based on our research, most companies rank this as one of many priorities or a high,
but not the highest, priority. That’s a good starting point. If this is where your company
is, go ahead and skip to the next question. If this is considered a low priority or not a
priority at all, you will encounter problems achieving digital maturity. We found that the
importance of digitizing quality is directly proportional to how big a company is. However,
the importance of digitizing quality was fairly consistent across all industries.

If you don’t think digital transformation is given enough consideration at your company,
what you do next depends on your position in the company. If you’re a manager or
executive, you can more directly affect your superiors’ attitudes toward digitization.
Even if you’re further removed from the executive team, you still have influence when
it comes to your manager. The biggest driver for digitization is competitive advantage
and executives will be interested in getting ahead of the competition. Anyone in a
managerial position or higher will be interested in accurate metrics and data analysis
that can only be achieved through digitization. Just bring up this current deficiency
whenever you’re asked to gather and report metrics.

How advanced is your current quality system?

Take a detailed look at how your quality department runs. How much paper is involved
in critical processes for quality and compliance? Have you had any audit or inspection
findings related to your quality system? If you are on a digital system, is it an on-
premise system or have you moved to the cloud? Or is everything so interconnected
that you can easily exchange information between your enterprise systems?

An obstacle that still pops up when it comes to digital transformation is moving to the
cloud. Your company leaders might consider the cloud to be risky, especially if they've
grown accustomed to an on-premise system and think of that as a more secure way
to store their data. The problem with this attitude is that it ignores the benefits that
can be gained from the connectivity presented by cloud solutions. Further, SaaS
companies have more time and resources to direct toward cybersecurity, whereas the
IT department of a life sciences company finds itself largely telling users to try turning
their computers off and then on again.

How many of your processes are digital across your organization?

This question deals with how many digital systems you have, how fully integrated
they are, and how many sites have them. Ideally, your digital systems will be fully
implemented at all sites. However, we found that this is only the case with 25% of
respondents. So, if you don’t fall into that category yet you’re hardly alone, but that’s
no reason to remain stagnant. In fact, there is a great way to incrementally build out
your digital transformation and get ahead of the competition.

You can start with the sites that do have digital systems and determine if they’re
fully implemented and being used in the most efficient way possible. When they
are, you can begin expanding use to other sites. One MasterControl customer
used this process. In a global organization, the idea of implementing a new QMS at
every site simultaneously caused ulcers. They focused on getting MasterControl

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 Research Report

fully implemented at a handful of sites until they felt sufficiently experienced with
the system to expand use. With this approach, they were able to improve quality
processes and carry those efficiencies into every new implementation. Digital
transformation is best done step by step because that gives you time to ensure things
go as planned and make necessary tweaks to your plan.

Less than What are your goals for quality management processes?
half (42%) This is less about your current state and much more about where you want to be in
of respondents the future. It’s very common for companies to want to digitize, but less common for
them to have a plan in place for how to do it. Less than half (42%) of respondents have
have a formal a formal digital transformation plan in their organizations. This was another metric
digital directly tied to the size of an organization, with formal plans being more common in
transformation larger companies.

plan in their A formal plan is essential in order to know if you’re making progress. Whatever
organizations. your quality management goals are, you need a tactical plan leading to your goal
and a measurement strategy to gauge success. Without something concrete to
measure, you’ll never know if you’re making progress or what you’ve gained from your
digitization. For example, you could set a goal to cut down on the amount of time it
takes to prepare for an audit. You would then need to determine what contributes to
the audit length and how you could cut time there. You’ll also need to know how long it
takes you to complete an audit with your current processes, so you have a benchmark
to measure progress.

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 Research Report

Likelihood of Progress to Intelligent

Progressing to Connected Connected 50%
and Intelligent Tiers
in 5 years
Digital 39%
7.Manual 17%

Connected Next Steps

Progress to Connected
Digital
Manual As previously stated, most of the companies77%
Digital we
spoke
Manual to fell into the digital tier. Of those,
61% 77% were
confident they could move to the connected tier in
the
0 next five years
25 and 39% 50thought they could
75 reach 100
the intelligent tier in that same time period. For those
in the connected tier, 50% thought they could reach
intelligent in the next five years. Moving to the next tier
within five years doesn’t have to be the goal for your
business, but whatever that goal is, planning to reach
it needs to start now.

Likelihood of Progressing
to Connected and
Intelligent Tiers in 5 years

Currently Connected Likelihood to Likelihood to

Progress to Connected Progress to Intelligent
Currently Digital
100
Currently Manual

77%
75
61%
50%
50 39%

25 17%

0
Manual Digital Manual Digital Connected

21
 Research Report

Keep in mind, there is no one solution for a digital transformation. Start by focusing
on your biggest pain points and choose software vendors that can resolve those.
While evaluating different vendors for the different aspects of your business, look for
vendors that have compatible goals. For example, if your goal is to be in the intelligent
tier, your vendor should, at the very least, have AI initiatives on their roadmap but
ideally, they would have AI built into their systems today.

MasterControl has been an industry leader in the life sciences for nearly 30 years.
Our software was among the first to be 21 CFR Part 11 compliant. We’ve seen quality
make the transition from using largely paper-based processes to mostly automated
ones. Now we’re providing our customers with AI-enabled functionality to help them
avoid tedious tasks and spend more time on meaningful ones.

We offer solutions to connect your organization on the same system. The best
example of this is connecting quality and manufacturing. With our products,
customers are completely eliminating data entry errors. They’ve also greatly reduced
the amount of time it takes to review a batch before sending it out. One company went
from reviewing batches in 2-3 hours to doing it in 10-15 minutes. Unless our math’s
way off, that’s an 87.5%-94% improvement!

We’re also making it even easier to manage quality events in MasterControl.

Collecting data and determining workflows are a big part of QEM, but so is ensuring
validation. Our customers can customize workflows and change field types quickly to
get what they need. They can implement changes with just a few clicks and validate
the new workflow in a similarly easy manner.

Would you like to see similar improvements in your company? Start by determining
where you are and learning how to move ahead. We’ve prepared an assessment to
tell you where your company stands and we’ll give you ideas on how to take steps to
progress in your digital maturity.
Take Assessment

Take Assessment

About MasterControl
Likelihood of Progress to Intelligent
MasterControl Inc. is a leading provider of cloud-based quality and manufacturing
Progressing to Connected Connected 50%
software for life sciences and other regulated industries. For three decades, our
and Intelligent Tiers mission has been the same as that39%of our customers – to bring life-changing products
Digital
in 5 years to more people sooner. MasterControl helps organizations digitize, automate, and
Manual 17%
connect quality and manufacturing processes. Innovative MasterControl tools have
a proven track record of improving product quality, reducing cost, and accelerating
Connected
time to
Progress tomarket.
ConnectedOver 1,100 companies worldwide use MasterControl solutions
Digital
to streamline operations, maintain compliance, easily analyze and interpret large
Manual
Digital 77%
amounts of data, and visualize business insights in real time.
Manual 61%
For more information, visit www.mastercontrol.com.

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