The

Ultimate
Guide to
Digitizing the
Shop Floor

Chapter

1 The State of Digital Transformation in Manufacturing

2 Digitalizing Quality-at-the-Source

3 Extend Your Digital Edge

4 Empower Smart Operators

5 Achieve Perfect Production

6 What a Truly Connected, Paperless

Environment Looks Like
1
Ultimate Guide

The State of
Digital Transformation
in Manufacturing
 Ultimate Guide

A
s Industry 4.0 initiatives and digital in various areas of manufacturing,
transformation efforts get off the many manufacturers stop short of
digitizing the “last mile” of their factory
ground, ongoing advances in Industrial
floor, where operators typically still
Internet of Things (IIoT), artificial use paper-based production records.
intelligence (AI) and robotic process Whether these manual, paper-based
automation are making their mark on everything records are called batch records,
from product assembly to quality inspection device history records (DHRs),
to equipment maintenance and even good production travelers, routers, etc.,
manufacturing practice (GMP) documentation. companies often pause or falter
when it comes to fully digitizing and
It’s no wonder that leading Clearly, manufacturing companies automating them.
manufacturing companies today are are feeling the pressure to determine Despite the investments
focusing heavily on fully digitizing and how digital fits into their business manufacturers have made in core
integrating information technology models and the right ways to leverage system digitization and industrial
(IT) and operational technology (OT) its possibilities. Based on data from automation – from enterprise resource
capabilities. Worldwide spending 300 manufacturing industry CEOs, planning (ERP), manufacturing
on the technologies and services professional services firm KPMG execution systems (MES) and material
that enable digital transformation found that 95% of respondents requirements planning (MRP), to
is forecast to reach $2.3 trillion in believe technological disruption is laboratory information management
2023, according to the International an opportunity and not a threat, and systems (LIMS) and supervisory
Data Corporation (IDC). The market nearly two-thirds of respondents agree control and data acquisition (SCADA) –
research firm estimates that discrete that acting with agility is “the new the investments are too often impeded
and process manufacturing will deliver currency of business; if we’re too slow, by critical processes that remain
the largest digital transformation we will be bankrupt.” manual, disconnected and often paper-
spending amounts throughout the Of course, strategic initiatives like based activities. Manual processes still
forecast, accounting for nearly 30% Industry 4.0 and digital transformation dominate the shop floor, where people
of the worldwide total. A 2019 report aren’t as simple as buying and on the production line have been left
from PricewaterhouseCoopers and implementing new software. In to deal with paper, spreadsheets
the Manufacturing Institute also found KPMG’s findings, more than a third of and other standalone systems to
that 73% of manufacturers planned manufacturing CEOs admitted their create, maintain, approve and release
to increase their investment in smart organizations are struggling to keep production records.
factory technology over the next year. pace with the rate of technological
innovation in manufacturing,
and almost half aid most of their
technology investments are tactical.
Even as Industry 4.0 efforts and
underlying technologies accelerate
 Ultimate Guide

At every step, manual processes Data integrity is amongst the top While digital technologies create
are slow, cumbersome and subject items cited on U.S. Food and Drug huge opportunities for manufacturers’
to human error. Companies that Administration’s (FDA) warning letters, ability to improve processes and
use paper-based production record according to GxP inspection analytics mitigate common errors of manual,
processes often encounter many of firm Govzilla. In fact, the FDA cited paper-based production records
the same problems across production data integrity on 79% of the drug that lead to FDA observations, few
and quality: warning letters over the last five years, have taken full advantage of them.
and they have increased the number of According to a recent study by
warning letters citing data integrity by Zebra Technologies, a majority of
1 Inefficient processes.
over four times. manufacturing executives surveyed
2 Inaccurate information.
“Failure to document quality unit said their organization uses pen and
responsibilities and procedures was paper to track vital manufacturing
3 Poor data tracking. once again the top citation in the steps, while 50% reported using
agency’s Form 483 reports,” according spreadsheets or a computer on wheels.
4 Disconnected systems. to an FDAnews analysis of the FDA’s By digitizing and automating the
good manufacturing practices (GMP) “last mile” of the production process,
5 Preventable quality issues. inspection reports for 2019. “It’s been life sciences organizations can capture
the top citation for over a decade – the manufacturing data and insights
6 Friction between manufacturing
often by a wide margin.” needed to optimize production, reduce
and quality.
The second most frequent GMP deviations and corrective/preventive
lapse was failure to thoroughly actions (CAPAs), improve right-first-
Life sciences organizations are review unexplained discrepancies or time (RFT) metrics and accelerate
well-aware of the high potential costs batch/component failures to meet product release. A digital production
of relying on outdated, paper-based specifications, which moved up from records solution can extend digitization
processes and documentation in a third place, according to FDAnews. to the edge users who need it most,
data-driven world – product recalls, closing the digital gap and delivering
warning letters, consent decrees, significant quality and productivity
costly shipping delays and, of course, improvements.
poor customer satisfaction.
 Ultimate Guide

By the Numbers:
Digital Transformation in
Manufacturing

95%
of manufacturing
industry CEOs believe
technological disruption
is an opportunity and
not a threat.
KPMG
30%
of the $2.3 trillion forecast to be spent
worldwide on digital transformation

1
technologies and services in 2023 will

#
likely be driven by discrete (e.g., medical
device) and process (e.g., pharmaceutical)
manufacturing.
International Data Corporation (IDC)

Failure to document
quality unit
responsibilities and
58% 73%
of biopharma of manufacturers
procedures was the top executives, business plan to increase their
citation in the FDA’s leaders and analysts investment in smart
Form 483 reports in say digital is a factory technology
2019. It’s been the top management over the next year.
top citation for over priority. PricewaterhouseCoopers and
a decade – often by a the Manufacturing Institute
Deloitte and MIT Sloan
wide margin. Management Review
FDAnews
 Ultimate Guide

Discover Manufacturing Excellence

MasterControl Manufacturing Excellence™ is a new breed systems (QMS) – and empowering the workforce that drives
of manufacturing application: mobile-first, operator- the last mile of production, MasterControl’s Manufacturing
centric and data-driven. Bridging the digital gap between Excellence™ solution eliminates human error and
core enterprise systems – resource planning (ERP), maximizes manufacturers’ information technology (IT)
manufacturing execution systems (MES), material and operational technology (OT) investments.
requirements planning (MRP) and quality management

MasterControl 
Manufacturing Excellence™ 

Robust Capabilities for Your Workers and Business

Fully digitize production records – batch records, device history

1 Digital Production Records records (DHRs), travelers, routers, etc. – so data is digital from
beginning to end, with no paper forms or offline processes to be
reconciled manually.

Empower the production workforce with work instructions and

2 Digital Work Instructions standard operating procedures (SOPs) that are always up to date,
with real-time tracking of stages, steps and performance.

Ensure quality at every step of production, and automatically

3 In-Line Quality Assurance assess risk and launch quality events, such as nonconformance and
deviations, directly from the production line without interruption.

Enforce training compliance with fully automated, user-based

4 In-App Operator Training training checks and in-app training delivery, so your workforce never
completes a task without complying with training requirements.

Automate and manage equipment calibration and maintenance tasks

5 Equipment Compliance to improve quality and compliance, minimize downtime and help
avoid bottlenecks.
2
Ultimate Guide

Digitalizing
Quality-at-the-Source
 Ultimate Guide

The Problem with

Paper-Based Production Records
When manufacturers Moreover, managing production records, retrieving information and
use a paper-based records manually, with every step of reviewing records. In a survey of
the process undertaken by hand and senior executives from medical
system to manage
on paper, often leads to inaccurate or device, contract manufacturing and
production records, missing information on the production pharmaceutical companies, Accenture
line workers and quality record due to scribal errors. Such found that quality testing and batch
teams must rely on human error accounts for downtime, release accounts for upwards of 70%
inefficient processes cost overruns and product sitting of manufacturing lead time mainly due
and poor data quality. unshipped. According to a Vanson to manual processes, disconnected
Manual, paper-based Bourne and ServiceMax study of the instruments and non-standard
systems limit the ability expenses, causes and consequences paper-based documentation and
to track manufacturing of unplanned downtime, 20% of all control procedures.
changes, identify unexpected manufacturing downtime Manual data entry errors,
quality events and take is the result of user error. remediation and review, along with
corrective action in Cumulative human errors turn insufficient tracking capabilities, drive
into poor data that then snowballs production costs up while reducing
real time.
into deviations and delays. With efficiency, throughput and profits.
manual, paper-based production These preventable errors result in
record processes, both time and shipping delays, wasted resources
money are wasted correcting paper and poor cash flow.

20%
Unplanned
40%
Preventable
70 %
Longer
80%
Poor Data
Downtime Deviations Lead Times Integrity
Over 20% of all Up to 40% of all Up to 70% of The FDA cited poor
unplanned downtime deviations are caused manufacturing lead manufacturing data
in manufacturing is the by some form of time is due to manual integrity on almost 80%
result of human error. human failure. processes and paper- of FDA warning letters
based quality and batch over the last five years.
review processes.
 Ultimate Guide

Achieve
Right First Time,
Every Time
The shop floor is The fully connected Manufacturing By eliminating the documentation
a critical, but often Excellence solution provides a truly burden and automating the labor-
paperless, error-reducing system for intensive last mile of the production
overlooked, opportunity
maintaining and tracking production process, MasterControl Manufacturing
to make quality data that affects quality. Error- Excellence™ enables quality managers
proactive rather proofing features reduce mismarks and plant line supervisors, operators
than reactive. or missing information on production and managers to focus on improving
Every operator, every records, with automated real-time the quality and throughput of their
step and every output quality review at each step on the product, not of their production records
of the production production line, to help ensure lots – achieving right-first-time (RFT)
process is a chance are right the first time. You can track production every time.
to establish quality manufacturing changes automatically
and compliance – and identify quality events and take
but only if operators corrective action in real time, to
are empowered to drive immediate improvement and
operational efficiency.
deliver quality at the
source. MasterControl
Manufacturing 1 Eliminate data input errors.
Excellence™ is the
missing link, enabling 2
Validate production record
manufacturers to processes in real time.

build quality into the Reduce deviations and corrective/

3
production process, preventive actions (CAPAs).
not outside of it.
Enforce quality controls without
4
slowing production.
 Ultimate Guide

Hidden Costs When manufacturers employ paper-based systems,

human errors and poor data integrity have a ripple effect as

of Quality:
the data advances through the production process, slowing
everything down. The ripple effect starts on the shop floor,

A Ripple Effect
where data-input errors on the production record lead
to paperwork issues, more deviations/nonconformances,
holds and downtime. These outcomes result in non-
productive time, such as employees having to leave the
production line for standard operating procedures (SOPs),
The costs of quality are high in work instructions or training. This non-productive time, in
modern manufacturing. Even a small turn, requires most organizations to increase their quality
amount of paper on the factory floor control efforts and expenditures to identify and locate the
results in real consequences on a errors they know exist.
manufacturer’s success. Manufacturing leaders can no longer afford to rely on
manual, paper-based systems to manage quality and
production, largely due to this ripple effect of bad data.

5. Lost Revenue

1. Bad Data

4. Increased Quality
Time & Expenses

3. Non-Productive Time 2. Deviations

 Ultimate Guide

3
Ways to
Build Quality Assurance
into Production
1 Launch digital quality forms directly
from production records.

2 Automatically launch training and

enforce training compliance.

3 Link SOPs/work instructions to

production record phases.

4
6
Paper-Based Benefits of
Review Embedding
Problems Quality
in the
Production
1 Lot release delayed by Process
manual GMP reviews.

2 Lower shipment and

delivery-to-commit rates. 1 Integrated quality and
manufacturing management.
3 Resources tied up
in paperwork. 2 Greater visibility.

4 Human errors slowing

3 Robust manufacturing processes.
cash flow.

4 Accelerated production record

processes.

5 Improved cycle times and efficiency.

6 Enhanced line performance.

 Ultimate Guide

The Digital Difference

MasterControl Manufacturing Excellence™ has the unique ability to deliver
very tangible improvements to key manufacturing operations and product
quality KPIs in a short timeframe at a relatively low cost. It is also easy for
production workers and line operators to learn and use – leading to broad,
sustainable end-user adoption.

75%-80%
acceleration
90%-100% of GMP record
review and
decrease product
in common release
data input
errors

30%-40% 20%-25%
fewer reduction
individuals in total
dedicated to manufacturing
GMP record deviations
review
 Ultimate Guide

Manufacturing
and Quality:
No More Us vs. Them
Manufacturing Leveraging digital tools to For both production and quality
operations and quality capture data and glean insights teams at Wellington, implementing the
needed by both quality assurance MasterControl solution together has
departments often
(QA) and manufacturing operations been a benefit.
clash because of their teams benefits both functions and
seemingly competing facilitates better communication
priorities, differing and collaboration in corrections and A lot of the input
approaches verifications. Collecting, connecting
and misalignment. and contextualizing metrics, data
that has come from
Whereas quality prioritizes complete and insights needed by both quality production, quality
paperwork, followed quality control teams and manufacturing teams helps sees value in it, and
address shared processes, including:
processes and up-to-date training, a lot of the stuff that
manufacturing’s goals tend to
embody minimal downtime, maximum quality has added to it,
1 Document revisions.
throughput and fast time-to-ship. production sees value
“Production and quality, by nature, 2 Good manufacturing in it,” according
have never gotten along,” says Robin practices (GMPs).
Joyner, MasterControl system to Robin Joyner,
administrator at Wellington Foods. 3 Training. MasterControl system
4 Sampling/testing. administrator at
5 Review and release.
Wellington Foods.
“So, it kind of takes
away that ‘us against
them’ mentality.”
3
Ultimate Guide

Extend
Your Digital Edge
 Ultimate Guide

Disconnected Systems,
Data Sources and Processes

Despite manufacturers Many manufacturers still rely on where disconnected information

investing heavily in a variety of only partially digitized systems cause problems are in
processes – therefore partially inventory management, time-logging
enterprise automation,
paper-based – or disconnected systems and personnel training,
particularly enterprise information systems that offer little among many others.
resource planning communication or interoperability Poor communication between
(ERP), material between one another. Paper-based disconnected information systems
requirements production records don’t automatically like ERP, MES, learning management
planning (MRP), integrate with electronic systems systems (LMS) and quality
and manufacturing or other quality processes, making management systems (QMS) severely
execution systems complete information transfer all limits the throughput between
(MES), people but impossible. Like paper-based manufacturing, quality and other
responsible for systems, electronic systems, if critical business areas, which impedes
production records siloed, insufficiently track data and physical operations and generally
have been left to documents from different areas undermines stakeholder collaboration.
throughout the production life cycle, These disconnects, bad data and
deal with paper,
resulting in information gaps, blind the resulting lack of visibility and
spreadsheets and other spots and preventable errors. collaboration across the enterprise
standalone systems In terms of systems where lead to a host of business inefficiencies.
to monitor, collect connecting via digitization reduces According to IBM, poor data quality in
and aggregate data information gaps, consider as an the U.S. alone costs $3.1 trillion a year.
surrounding production example reconciling the ERP bill of
and quality processes. materials (BOM) with the production
BOM in real time. Here, challenges
are common due to manually
recorded materials, scrap, etc.,
leading to variances. Other areas

3 Major
Pains of Paper

1 Inaccurate Data
2 Poor Traceability
3 Disconnected Processes
 Ultimate Guide

Digitize Beyond Your Core Systems

When it comes to digital transformation in both quality
and manufacturing, LNS Research recommends an
integrated network of systems and processes.

To collect, connect and contextualize Capture and share real-time The Digital Difference
1
the data and insights needed to production data across systems
optimize manufacturing and ensure and departments seamlessly.
quality throughout the production
Connect all users across the
2

30%
life cycle, companies must integrate shop floor, letting operators
their production record processes input data directly into tablets.
with their ERP, MES, QMS and other
core information systems for a more 3
Eliminate data integrity issues increase
before they spread through the
complete view of the data within their
production life cycle.
business. For example, operators on
the shop floor should be able to input in employee efficiency,
production data directly into tablets According to Aberdeen, reducing overall
approximately 47% of manufacturing
and pull product or materials info production costs.
from the organization’s ERP. organizations believe they must
Legacy Pharmaceutical Packaging, LLC
With a digital system like become more data-driven to remain
MasterControl Manufacturing competitive. By integrating the
Excellence™, you can create productive disparate enterprise applications in
connections between enterprise your manufacturing IT ecosystem

50%
systems, data sources, processes with a fully digital production record
and people throughout your entire system, you can close the digital
organization, for a holistic view of data. gap and glean truly actionable,
data-driven performance insights
reduction
Rather than replace your organization’s
existing ERP, MES and MRP systems, to deliver significant quality and
the MasterControl solution extends productivity improvements. This
them to the shop floor, automating way, personnel can focus on the
product rather than paperwork. in individuals required
the labor-intensive “last mile” good
to manage production
manufacturing practice (GMP)
review and release to drive immediate
record paperwork.
operational productivity and DATA PULLED DATA PUSHED Wellington Foods
quality improvements.
Materials Product Materials Product
• Lot # • Lot # • Lot # • Lot #
• Name/ID • Name/ID • Name/ID • Name/ID
• QTY Available • QTY • QTY Used • QTY Created
• Expiry • Expiry • Step # • Expiry
• Unit of Measure • Theoretical • UTC Time Used • Materials Flush
• Status Yield • Routing # Used Back
• Revision/Version • Materials Pick • Scrap • Scrap
• Vendor/Lot # List • Retains
• Schedule Start
• Routing

DATA PULLED DATA PULLED

Product 1. ERP/MRP Materials

• Issues • Lot # • Routing # Used
• Complaints • Name/ID • Scrap
• QTY Used • Machine Data
• Step # •
• UTC Time Used • Parameters

MasterControl
4. CRM Production 2. MES
DATA PUSHED Record DATA PUSHED

Materials Product Materials Product

• • • Lot # • Lot #
• • Sales • Name/ID • Name/ID
• Quality • QTY Available • QTY
Agreements • Expiry • Expiry
• Manufacturing • Unit of Measure • Theoretical Yield

3. LIMS
Needs • Status • Materials Pick List
• Revision/Version • Schedule Start
• Vendor/Lot # • Routing

DATA PULLED DATA PUSHED

Materials Materials
• Lot # • Lot #
• Challenge/Test ID/Spec • Challenge/Test ID/Spec
• Parameters • QTY
• Test Results (Pass/Fail) • Step #
•
 Ultimate Guide

Collect, Connect and Contextualize

Your Production Data
MasterControl Manufacturing Excellence™ connects Integrate Manufacturing Excellence with your:
production and quality data with control, execution and • Enterprise resource planning (ERP).
enterprise systems by leveraging integration platform • Material requirements planning (MRP).
as a service (iPaaS) technology. The solution is also • Manufacturing execution system (MES).
compatible with proprietary application program • Laboratory information management system (LIMS).
interface (API) connections. • Customer relationship management (CRM).
• Quality management system (QMS).

DATA PULLED DATA PUSHED

Materials Product Materials Product
• Lot # • Lot # • Lot # • Lot #
• Name/ID • Name/ID • Name/ID • Name/ID
• QTY Available • QTY • QTY Used • QTY Created
• Expiry • Expiry • Step # • Expiry
• Unit of Measure • Theoretical • UTC Time Used • Materials Flush
• Status Yield • Routing # Used Back
• Revision/Version • Materials Pick • Scrap • Scrap
• Vendor/Lot # List • Retains
• Schedule Start
• Routing

DATA PULLED DATA PULLED

Product 1. ERP/MRP Materials

• Issues • Lot # • Routing # Used
• Complaints • Name/ID • Scrap
• QTY Used • Machine Data
• Step # •
• UTC Time Used • Parameters

MasterControl
4. CRM Production 2. MES
DATA PUSHED Record DATA PUSHED

Materials Product Materials Product

• • • Lot # • Lot #
• • Sales • Name/ID • Name/ID
• Quality • QTY Available • QTY
Agreements • Expiry • Expiry
• Manufacturing • Unit of Measure • Theoretical Yield

3. LIMS
Needs • Status • Materials Pick List
• Revision/Version • Schedule Start
• Vendor/Lot # • Routing

DATA PULLED DATA PUSHED

Materials Materials
• Lot # • Lot #
• Challenge/Test ID/Spec • Challenge/Test ID/Spec
• Parameters • QTY
• Test Results (Pass/Fail) • Step #
•

1. 2. 3. 4.
ERP/MRP MES LIMS CRM
 Ultimate Guide

By the Numbers:
Mind the Information Gap

18.4%
of executives from all
life sciences industries
emphasized disparate
quality systems and data
sources when asked their
top quality management
challenges.
LNS Research
20%
of executives in manufacturing operations
management cite disparate systems and data
sources among key challenges in addressing
top manufacturing objectives for life sciences
companies.
LNS Research

27%
of manufacturers are
collecting data from
production, supply
chain and workers, yet
46%
of manufacturers say increased visibility across
the data is remaining their operations will support growth and that they
in silos, rendering expect technology and automation to continue
useless much of the transforming the plant floor and delivering
intelligence it can quality improvements across all stages of
provide. production.
Zebra Technologies Zebra Technologies
4
Ultimate Guide

Empower
Smart Operators
 Ultimate Guide

When Digitization Leaves People

Out of the Process

Smart manufacturing efforts have use cases are among the most impactful, including asset
too often focused on systems and performance monitoring, predictive maintenance and
prescriptive service.
machines rather than on people,
The rise of digitally connected workers reflects
sometimes “optimizing” workers out “the conventional wisdom that improvement, whether
of the process altogether. incremental or step-change, calls for holistic alignment of
Now, organizations are shifting to a more holistic view of the right people, process and technology capabilities,” the
connected operations that digitally integrates people and research and advisory firm says.
systems across operations. Like the industrial revolutions The real benefits of digital transformation can only be
before it, Industry 4.0 is bringing about changes that are achieved when it supports workers. Process automation
based on the degree of connectivity between frontline is about optimizing people and processes to increase
workers and their work environment. efficiencies and decrease the chance of human error.
“Use cases in the initial wave of industrial transformation This releases humans from needing to perform specific,
(IX) investment focused on using asset-related data and repetitive tasks, which in turn leads the way to enhancing
advanced analytics to drive improvement in areas such as worker performance.
asset reliability, energy management, and product quality,”
LNS Research says. “Now, there is a strong trend towards
an integrated approach that incorporates workforce
considerations into IX initiatives and using people-related
data to drive improvement in the overall operational
management system.” With a human-centric approach
With a human-centric approach to technology, life
sciences manufacturers can extend process improvement
to technology, life sciences
activities to the edges of operations – where paper persists manufacturers can extend process
and enterprise systems are disconnected from the factory improvement activities to the
floor – empowering digitally connected workers to thrive
within a data-driven manufacturing environment. In this
edges of operations – where paper
environment, personnel can leverage such technologies persists and enterprise systems are
as augmented reality and smart wearables for use cases disconnected from the factory floor
across production, maintenance, field service and more. In
LNS Research’s findings, asset- and equipment-focused IX
– empowering digitally connected
workers to thrive within a data-driven
manufacturing environment. ”
 Ultimate Guide

Smart Applications
to Drive Transformation
Digital technology MasterControl Manufacturing Time spent in the past on paper
should support and Excellence™ takes a human-centric systems and manual data formatting
approach to digitization, focusing on and math calculations can now be
enhance people, not
such areas as data input, information done electronically and automatically,
replace them. access, in-context information and freeing up people to focus on value-
On the factory floor, where the next prescriptive actions. The solution adding activities, leverage their
generation of employees entering error-proofs data input, automates intuition, experience and insight, and
the workforce and advancing through review/traceability of changes drive transformation.
the ranks are digital natives, digital on records, facilitates the multi-
technology should extend the directional flow of data and actionable
critical role people play in frontline insights and applies advanced
operations from limited interaction analytics to equipment calibration and The leadership
with elements of the overall operations maintenance. Line workers can easily now has visibility
management system to a high degree
of interconnectivity.
capture all entries on a production from anywhere in the
record in real time, with automatic
“I’m a digital person. I’m not into data-integrity checks ensuring the company to look at a
the paperwork and having to do all data is entered completely and batch record. They can
of the documentation,” says Jimmy
Sareñana, manufacturing operations
correctly. The solution provides watch this in real time,”
contextualized intelligence, prompts
manager for MasterControl customer and risk-based recommendations to according to Robin
Wellington Foods, a contract operators in real time. Joyner, MasterControl
manufacturer of dietary supplements
and nutritional products. “And the
system administrator at
other personnel, these kids, coming 1
Integrated, data-driven
prompts guide operators
Wellington Foods.
into the operations ... a lot of them are through work instructions, “It makes my job a whole
used to tablets and phones, so that enforce out-of-specification
kind of stuff is just going to make it a and nonconformance limits and
lot easier because I’m not
whole different game.” thresholds, ensure operator trying to justify and prove
training is always current, and
notify operators of all open to them the benefits of
deviations and corrective/
preventive actions (CAPAs).
it. They’re seeing the
true benefits, not just
2
In-process dashboards provide from a dollar standpoint
real-time visibility into the
status of production lines,
but from freeing up
batches or lots, and operator employees.”
performance between different
lines and shifts.

Lot runtime dashboards display

3
current runtime data alongside
historic runtime data, including
throughput metrics, CGMP error
rates, out-of-specification and
nonconformance events.
 Ultimate Guide

Better Data for

Better Decision Making

With improved access to shop floor

Our management’s As MasterControl’s
data, process engineers can make
better, quicker decisions about philosophy from EBR makes processes
nonconformances, deviations and day one with using more efficient, we are
corrective/preventive actions (CAPAs).
MasterControl’s able to find more hours
Data from the digital production records
can be used to glean real-time insights, electronic batch records in people’s days that
identify bottlenecks and evaluate the was to get people to can be applied in much
results of quality and compliance checks.
focus on the right things. more efficient and
Data-driven manufacturing with
What makes a quality beneficial ways.”
digital production record tools empowers
manufacturers to: product better is being Tony Harnack,
able to focus on the President of Wellington Foods

Gain greater visibility throughout the work, not the paper.”

production life cycle.
Robin Joyner,
Improve efficiency and MasterControl System Administrator at
optimize operations. Wellington Foods

Address production issues

before problems arise.

Improve overall product quality.

5
Ultimate Guide

Achieve
Perfect Production
 Ultimate Guide

A Shortage of Actionable Insights

There can be no “smart processes, departments and people, to
manufacturing” without and from a company’s physical assets Companies that
operational intelligence. – all for a more holistic view of data. are able to leverage
“Companies that are able to leverage
Manufacturers’ goal is ubiquitous data in meaningful ways
ubiquitous data in
always to deliver more – across product development, sales meaningful ways – across
product faster, at lower
costs and with fewer
and operations; across devices; and product development,
with customers – are developing new
quality issues. models of collaboration,” according
sales and operations;
Yet inadequate or siloed data is to PricewaterhouseCoopers (PwC). across devices; and
rendering much of the intelligence that “The winners will be those with customers – are
companies that use digitization
data can provide useless in efforts to
to successfully introduce greater
developing new models
accelerate product delivery, reduce
costs and minimize quality issues. flexibility, customization and speed of collaboration.”
To capture and leverage the data into their operations while also staying
PricewaterhouseCoopers (PwC)
and insights needed to optimize cost-competitive.”
production, reduce deviations and Manufacturers are not oblivious to
corrective/preventive actions (CAPAs), this opportunity. According to 2018-
improve right-first-time (RFT) metrics 2019 research from Gartner, 64% of
and accelerate product release, manufacturing decision makers expect
manufacturers must use digitization more than 50% of their production data
to create productive connections and information flows to be automated
and product data flows across value in two years.
streams through systems, machines,

By the Numbers:
Impossible Performance Insights
with Inaccessible Data

25%
of executives in manufacturing
26.3%
of executives from all life sciences industries
operations management placed considerable focus on effectively measuring quality metrics
cite timely visibility into when asked about their top quality management challenges.
manufacturing performance LNS Research
metrics among key challenges
in addressing top manufacturing
objectives for life sciences
companies, followed by disparate

79%
systems and data sources (20%) of the FDA’s drug warning letters
and lack of collaboration across over the last five years cited data integrity.
different departments (20%).
Govzilla
LNS Research
 Ultimate Guide

Real-Time Production Intelligence

Digitizing the collection and flow
The full effect of digitization on manufacturing
of data means manufacturers can
operations is only realized when manufacturers are better understand how their shop
able to correlate production, supplier and quality data floor is working and make data-
to glean real-time, actionable insights. MasterControl driven product- and process-related
Manufacturing Excellence™ achieves this by creating decisions. Greater access to data
connections. The digital solution enables the free from the factory floor enables
flow of data and communication between different quicker, more informed decisions
enterprise systems, equipment and people. when it comes to nonconformances,
deviations and CAPAs. Providing
stakeholders with immediate access
With Manufacturing Excellence, For instance, the MasterControl to this data will increase efficiency,
machine operators can input data solution automates and manages reduce unplanned downtime and
directly into tablets or computers routine calibration activities and enable end-to-end traceability
on the shop floor, connect and pull record-keeping for more efficient throughout production and beyond.
information directly from an enterprise manufacturing performance, and it The culmination of this data-
resource planning (ERP) system and manages the equipment maintenance centric, platform-connected and
log customized production record schedule and automatically easily integrated ecosystem will be a
documents in real time. Operators can generates preventive maintenance model in more dynamic intelligence
link standard operating procedures tasks before they’re due. Digital and manufacturing operations
(SOPs) and work instructions to production record forms can easily being brought closer to perfect
production record phases, launch be revised to reflect a company’s production. On average, life sciences
deviations, CAPAs and other quality quality and compliance efforts, manufacturers that have gone fully
processes directly from the production allowing equipment maintenance paperless on the shop floor with
record, automatically launch and procedures to be updated in-process, MasterControl’s digital manufacturing
enforce training on the production line, resulting in quicker maintenance solution have seen a 90% decrease in
and even ensure equipment compliance activity completion and more reliable data input errors, a 21% reduction in
in real time. uptime for crucial components in the total deviations and a 75% reduction in
manufacturing process. post-production review.

Paperless Initiatives on the Shop Floor

Advantages of going paperless with a digital system:

Capture real-time Quickly identify Automate traceability Easily collaborate

production data. bottlenecks and and audit-readiness. across departments.
production issues.
 Ultimate Guide

The Digital Difference Manufacturers Technology-Driven

should harmonize Process Improvements
No more missing or Gaining immediate access to digital
1
illegible data fields. processes, automate production record data will:
these processes with
No more incomplete
2
documents. software, connect 1 Streamline production processes.

No more outdated
automated processes
3
worker training. to other systems 2 Reduce unplanned downtime.

No more disconnected and operations, and

4
quality events. leverage collective 3 Ensure process compliance.

analytics and learnings Enable end-to-end traceability

4
to continuously improve throughout production.

system autonomy.
This approach shifts
the focus of high-value
staff away from the
mechanics of execution
and toward innovation
and improvement.”
LNS Research
 Ultimate Guide

3 Fundamental Ways
to Leverage Data Using
Manufacturing Excellence
By integrating critical software applications with
MasterControl’s Manufacturing Excellence™ solution,
manufacturers can leverage their data in three valuable ways:

1
Collect data
2
Connect data sources
3
Contextualize data
Easily configure the type, timing and Integrate the production record Guide operators and enforce limits,
frequency of data to be collected, process with other business systems, thresholds and training with integrated,
eliminate human errors that are including ERP, MRP, MES and LMS, and data-driven prompts, gain real-time
common when manually inputting share data between those systems visibility into lines, batches or lots, and
and transferring data, and ensure and functional areas completely, access current runtime data alongside
data integrity as data moves seamlessly and in real time. historic runtime data.
between systems.
 Ultimate Guide

SP O T L I G HT

Digitizing production records with

MasterControl Manufacturing Excellence™
has empowered EpiBone, an innovative
regenerative medicine company, to build
quality into production, eliminate paper-based
inefficiencies and ensure continuous validation.
Advances in the fields living grafts for skeletal approach and a five-week
of generative medicine, reconstruction. With just production cycle, efficiency is
computational biology and over a dozen employees, critical – production records
medical imaging are paving the the company produces a must be reviewed and
way for personalized medicine, combination product that is released quickly, completely
which promises to be a key a biologic with the attributes and transparently.
driver of the combination of a medical device, which With MasterControl’s
product market. Regenerative must meet FDA 21 CFR 820 cloud-based digital quality
medicine company EpiBone requirements. Due to the and manufacturing platform,
is among the innovative personalized nature of most EpiBone has built quality into
upstarts looking to harness of its products, EpiBone is production and dramatically
personalized medicine to often producing a unique improved the manufacture of
improve people’s lives. product that is a batch of one. the company’s clinical
Based in Brooklyn, New As a regenerative medicine grade products.
York, EpiBone is developing company with a personalized
 Ultimate Guide

Time savings since

implementing MasterControl:

FEATURE: FEATURE: FEATURE:

Master Record Review Validation

Template Builder By Exception Excellence Tool™ (VxT)
(U.S. Pat. 10,324,830)

BENEFIT: BENEFIT: BENEFIT:

Reduce time spent building Close out a production Reduce time spent validating
master record templates record in less than a day, software from weeks to
from months to days, and compared with the two hours, taking an FDA-
fully automate version weeks it took to sign off on recommended risk-based
change management. paper-based records. approach to validation.

By improving the efficiency of master record

revisions, we have produced cost savings equivalent to
cutting man-hours from one month down to one week.”
Pete Raghubans,
Quality Assurance Manager, EpiBone
6
Ultimate Guide

What a Truly Connected,

Paperless Environment
Looks Like
 Ultimate Guide

The Digital Difference

Paperless Errorless Connected Frictionless

Remove the last vestiges of Eliminate preventable Integrate production Reduce the friction between
paper from the shop floor, errors, long review cycles records with your core manufacturing operations
and ensure that product and costly waste created information systems for and quality assurance
review and release is by manual data entry to a complete view of your priorities and metrics to
fully digital, connected achieve right-first-time business data and actionable improve line performance
and accelerated. (RFT) production. performance insights. and accelerate production.

Review By Exception Paperless Production

Template Management

Data Entry and In-Line

Quality Events
Automated Training
 Ultimate Guide

Achieve Manufacturing Excellence

with MasterControl
Delivered through the powerful MasterControl platform, the fully connected
Manufacturing Excellence solution reduces production errors, improves cycle
times and efficiency, enhances line performance, accelerates product release,
and integrates manufacturing and quality management – ultimately unifying
manufacturing operations and quality priorities.

MasterControl 
Manufacturing Excellence™ 

Powerful Tools for Your Quality Manufacturing Needs

1 MasterControl provides the capabilities needed by medical device manufacturers to

gain total control of device history records (DHRs) and device master
eDHR™
records (DMRs).

2 MasterControl contains essential tools that pharmaceutical manufacturers need

to streamline and maintain orderly master batch records and batch
EBR™
production records.

3 MasterControl automates equipment calibration for more efficient manufacturing

performance.
Equipment Calibration™

4 MasterControl manages the equipment maintenance schedule and automatically

Equipment Maintenance™ generates preventive maintenance tasks before they’re due.

5 MasterControl reduces the time required to conduct risk-based software validation

Validation Excellence™ from months down to hours.

6 MasterControl allows discrete manufacturing companies to easily manage product

variant changes and substitutions in one master template to efficiently
Variant™
scale operations and create new products for existing or new markets.

7 MasterControl helps batch process manufacturers manage recipe changes and

substitutions – from ingredients to equipment and formulations –
Recipe™
in a single master recipe template, significantly reducing product
documentation and improving data visibility, tracking and analysis.
 Ultimate Guide

About MasterControl
MasterControl Inc. creates business processes throughout supplier management,
software solutions that enable the entire product lifecycle. More manufacturing and postmarket
life science and other regulated than 1,000 companies worldwide, surveillance. MasterControl
companies to deliver life-improving ranging in size from five employees solutions are well-known for being
products to more people sooner. to tens of thousands, rely on scalable, easy to implement,
MasterControl’s integrated MasterControl cloud solutions easy to validate and easy to use.
solutions accelerate ROI and to automate processes for new For more information, visit www.
increase efficiencies by automating product development, clinical, mastercontrol.com.
and securely managing critical regulatory, quality management,
 Ultimate Guide

References

Chapter 1

1. Worldwide Spending on Digital Transformation Will Reach $2.3 Trillion in 2023...,

International Data Corporation, October 2019. https://www.idc.com/getdoc.jsp?containerId=prUS45612419
2. Navigating the Fourth Industrial Revolution to the Bottom Line,
PricewaterhouseCoopers and the Manufacturing Institute, September 2019. http://www.themanufacturinginstitute.
org/~/media/B8C99947A3AF4A8B843AD66202DDD4EE/Smart_Factory_4IR_Reportv8.pdf
3. 2018 Global Manufacturing Outlook: Transforming for a Digitally Connected Future,
by Doug Gates, Erich L. Gampenrieder, Tom Mayor and Charlie Simpson, KPMG International, June 2018. https://
institutes.kpmg.us/manufacturing-institute/articles/2018/2018-global-manufacturing-outlook.html
4. Data Integrity Trends In 483s And Warning Letters: Part 1,
by Michael De La Torre, Govzilla, May 2019. https://govzilla.com/blog/2019/05/pharma-medical-devices-data-integrity-
breaking-down-keywords-and-citation-trends-from-the-fda/
5. FDA’s Top GMP Inspection Findings for FY 2019,
FDAnews, September 2019. https://www.fdanews.com/articles/192882-fdas-top-gmp-inspection-findings-for-fy-2019
6. 2018 Manufacturing Vision Study… The Road Ahead,
Zebra Technologies, April 2018. https://cssi.com/2018/04/20/2018-manufacturing-vision-study-the-road-ahead/
7. Survey Finds Biopharma Companies Lag in Digital Transformation,
by Greg Reh and Mike Standing, Deloitte, October 2018. https://www2.deloitte.com/us/en/insights/industry/life-
sciences/digital-transformation-biopharma.html

Chapter 2

8. After the Fall: Cost, Causes and Consequences of Unplanned Downtime,

Vanson Bourne and ServiceMax, October 2017. https://lp.servicemax.com/Vanson-Bourne-Whitepaper-Unplanned-
Downtime-LP.html
9. Dare to Be Different: It’s Time to Revamp Collaboration in Life Sciences Contract Manufacturing,
by Anne Marie O’Halloran, Barry Heavey and Greg Ciccarelli, Accenture, 2019. https://www.accenture.com/_acnmedia/
pdf-98/accenture-life-sciences-dare-to-be-different-contract-manufacturing.pdf
10. Wellington Foods: How Electronic Batch Records (EBR) Drive Quality,
MasterControl, 2019. https://www.mastercontrol.com/?c=334

Chapter 3

11. The Four V’s of Big Data,

IBM. https://www.ibmbigdatahub.com/infographic/four-vs-big-data
12. A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences,
by Matthew Littlefield, Rob Harrison, Mike Roberts and Greg Goodwin. LNS Research, 2014. https://www2.
mastercontrol.com/sales=530
13. Data-Driven Manufacturing – Monetizing the Analytical Edge,
by Deb Geiger, Aberdeen, October 2017. https://www.aberdeen.com/opspro-essentials/data-driven-manufacturing-
monetizing-analytical-edge/
 Ultimate Guide

14. Metrics That Matter for Quality Manufacturing,

MasterControl, 2019. https://www2.mastercontrol.com/sales=854
15. 2018 Manufacturing Vision Study… The Road Ahead,
Zebra Technologies, April 2018. https://cssi.com/2018/04/20/2018-manufacturing-vision-study-the-road-ahead/

Chapter 4

16. Connected Worker: Connecting People and Systems to Transform Frontline Operations,
by Peter S. Bussey, LNS Research, 2019. https://blog.lnsresearch.com/connected-worker-2019#sthash.qVZ1WCeF.dpbs
17. Customer Testimonial by Wellington Foods on EBR,
MasterControl, 2019. https://www.mastercontrol.com/?c=304
18. Quality 4.0 Impact and Strategy Handbook: Getting Digitally Connected to Transform Quality Management,
by Dan Jacob, LNS Research, 2017. https://www2.mastercontrol.com/sales=698

Chapter 5

19. From the Plant Floor to the Top Floor: Doing Great Work Together,
PricewaterhouseCoopers, 2016. https://www.pwc.com/vn/en/industries/assets/fy-16-capabilities-statement.pdf
20. Evolve Your Manufacturing Intelligence Strategy to Keep Pace with New Analytics Requirements,
by Simon Jacobson, Gartner, July 2018 (refreshed November 2019). https://www.gartner.com/en/documents/3882877/
evolve-your-manufacturing-intelligence-strategy-to-keep-
21. How to Use Manufacturing Analytics for Intelligent Decision Making,
by Kamala Raman, Gartner, May 2019. https://www.gartner.com/en/documents/3913596/how-to-use-manufacturing-
analytics-for-intelligent-decis
22. A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences,
by Matthew Littlefield, Rob Harrison, Mike Roberts and Greg Goodwin. LNS Research, 2014. https://www2.
mastercontrol.com/sales=530
23. Data Integrity Trends In 483s And Warning Letters: Part 1,
by Michael De La Torre, Govzilla, May 2019. https://govzilla.com/blog/2019/05/pharma-medical-devices-data-integrity-
breaking-down-keywords-and-citation-trends-from-the-fda/
24. Personalized Medicine at FDA: A Progress & Outlook Report,
Personalized Medicine Coalition (PMC), February 2019. http://www.personalizedmedicinecoalition.org/Userfiles/PMC-
Corporate/file/PM_at_FDA_A_Progress_and_Outlook_Report.pdf
25. Q&A: EpiBone on Digitizing and Automating Their Production Records,
by David Butcher, GxP Lifeline, August 2019. https://www.mastercontrol.com/gxp-lifeline/q-a-epibone-on-digitizing-
and-automating-their-production-records/
26. Benefiting from Paperless Production Records: A Case Study,
by Terrance Holbrook, Orthopedic Design & Technology, September 2019. https://www.odtmag.com/
issues/2019-09-01/view_columns/benefiting-from-paperless-production-records-a-case-study/
27. MasterControl Customers Talk About the Validation Excellence Tool
MasterControl, 2020. https://www.mastercontrol.com/resources/?c=352

www.mastercontrol.com

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