Industry Brief

6 Must-Haves for a Industry Brief

Quality Management
System (QMS)
 Industry Brief

Introduction
How much does quality cost? Most companies would be hard-pressed to put a
dollar amount on quality. What they do realize, however, is that a lack of quality
could cost millions of dollars in rework, scrap, recalls, or even liability lawsuits.
An equally important, but more positive question is, how much does quality
earn? Better quality reduces costs, but it also increases sales, brand equity, and
productivity.

In regulated environments, such as those under the jurisdiction of the U.S.

Food and Drug Administration (FDA) and/or International Organization for
Standardization (ISO), quality is included in regulations and standards. So, quality
isn’t just good business, but also a matter of compliance and requires a good
quality management system (QMS).

The FDA states that “quality should be built into the product, and testing
alone cannot be relied on to ensure product quality.” The ISO 9000 series of
standards also points out the importance of making quality an integral part of a
manufacturer’s daily operations. In today’s world, doing this requires automated
manufacturing and digital systems.

6 Must-Haves of a QMS
The best way to build quality into a product is with an effective, connected digital
QMS. This is the foundation for long-term regulatory compliance and market
success. However, not every QMS has the same capabilities and connectivity. A
QMS that isn’t connected to other areas of the company and requires using rigid
processes with little flexibility slows down quality processes and introduces the
possibility of more human error.

Life sciences companies need a QMS that provides functionality across all areas
of quality. This includes document control, training management, quality event
management (such as corrective action/preventive action [CAPA] management),
etc. It also needs to integrate with other systems. The ideal QMS should let you
easily configure it to meet your processes, instead of forcing you to change your
processes to meet the QMS. A QMS that isn’t flexible will always slow down
processes and keep you from making changes to become more efficient. To find
that QMS, look for a system that does the following.

6 Must-Haves for a Quality Management System (QMS) 1


“We’re all [on] one site, and
so everybody around the
world is together. Now I
can see the documents
that Poland is working on
and vice versa. We haven’t
had that flexibility until
now.”
- Matt Seitz-Paquette, North
America Quality Specialist,
Fagron
6 Must-Haves for a Quality Management System (QMS)
Industry Brief
1. Enables Automation
Even in today’s business world, where technology is everywhere, many companies
in regulated industries still rely on paper-based or hybrid quality systems. While
a paper-based system can be compliant, it requires more time and effort to
maintain that compliant state. Every task that is automated in a QMS has to
be done manually when dealing with paper. That includes routing documents
for signatures, updating standard operating procedures (SOPs), and locating
documents for an audit or inspection.
Quality systems are complex, but manageable with a QMS that automates all
quality-related tasks for documents and forms, including:
• Routing.
• Tracking.
• Escalation.
• Review.
• Approval.
This applies to SOPs, training records, electronic production records, and anything
else that requires review and approval. Since these documents are all stored in
the same system, a company can always be prepared for an audit with the most
up-to-date version of each document, fully automated change control, and an
electronic signature trail.
Just because a system is automated doesn’t mean it can’t be flexible. Highly
configurable systems let you automate which paths a quality event management
investigation takes based on the data provided. Due to recent advances in
software validation you can make these changes quickly and then validate them to
ensure you’re operating in a validated state.
2. Connects All Areas of Quality Management
If putting a dollar value on quality is difficult, breaking the concept of quality into
sections is even more challenging. Consider the example of a defective medical
device, in which a new glucose monitor shows incorrect readings during testing.
An investigation of this product would cover the whole product life cycle. The
manufacturer would investigate the root cause of the problem through its CAPA
management process.
In this example, what if the CAPA investigation showed a weakness in product
design? A design change would be initiated and managed through the change
control process. When the change is approved and successfully tested (and proven
safe), this has to be documented. All updates in the documents for this product
would be managed through the document control process. Then, employees need
to be trained on those changes, which is part of the training control process. From
this perspective, it is virtually impossible to manage each aspect of quality as a
separate process.
2

90% reduction in
investigation cycle
time for deviations and
nonconformances when
companies use advanced
analytics.
6 Must-Haves for a Quality Management System (QMS)
Industry Brief
Since all areas of quality are connected, you need a fully connected QMS for
closed-loop quality management. This QMS would let you document your change
control and gather electronic signatures for approval. When you update related
SOPs, a QMS should automatically send out training tasks to employees. You
can also control which employees receive that training. This helps ensure the
corrective action is fully carried out without letting anything fall through the
cracks.
With a connected QMS, users can enter a quality event, investigate it, determine
corrective action, approve changes to or new documents, and send out training
automatically all in the QMS. This makes it very easy to show your process during
an audit and to quickly pull all documentation related to the original issue and how
it was resolved.
3. Provides Robust Analytics and Reporting Capabilities
Today’s manufacturing environment is competitive and fast paced. To get ahead,
businesses must not only ensure product quality, but also have insight into all
quality processes. Those in regulated environments need tools to help them see
trends and understand quality issues to proactively solve problems. Their ability
to adapt to changes and problems quickly can be the difference between a simple
CAPA or a product recall.
Enterprise systems hold all the data you need to make smart decisions for quality
and manufacturing but turning that into predictive quality analytics is difficult.
Collecting and analyzing data takes time, especially if you do it manually. Even if
you’re working with a digital system, Excel data dumps are a fact of life. It doesn’t
have to be that way, though. With complete quality data that is always up to date,
all the information you need is at your fingertips.
An advanced QMS offers features to track, trend, and report on the data within
the QMS. You can use the out-of-the-box reports in the QMS, but also easily
create your own with intuitive tools. The level of detail is flexible, allowing you to
see a broad overview or drill down into the details of the data. Forward-thinking
vendors will offer predictive quality analytics. An example of this is to tell you if
an employee is going to be overdue on training. Predictive quality analytics and
closed-loop quality ultimately improve your bottom line.
4. Flexible and Scalable
Automating a quality system is a major endeavor in terms of time, effort, and cost.
Rather than be forced to revamp their system often, businesses choosing a QMS
should consider how the system would support future growth at three levels:
1. Users (by the dozens, hundreds, or thousands).
2. Business units (domestic and/or overseas).
3. Operations (new products and services).
The system must be able to adapt to changes in the market and in the regulatory
environment.
3

50% improvement in
training cycles since UCSF
Health implemented
Quality Excellence.
45 minutes, average
upgrade validation time for
MasterControl VxT users.
6 Must-Haves for a Quality Management System (QMS)
Industry Brief
When looking for a QMS, consider how your company may change over time. As
you grow, can the QMS keep up? For example, can you begin using the product
with limited functionality and then expand your use? Can you go live at a single
site and then roll out to others? If you’re part of a large business that has multiple
other enterprise systems, make sure the QMS can integrate with those systems.
Flexibility is equally as important. A difficult part of user adoption is when you
need users to change how they do things to fit the system. That’s why it’s easier
to find a QMS that can be changed to fit your current processes. This can be
done through custom code, but that makes it difficult to make any changes
without heavy services fees. A no-code QMS that can be configured to match
your processes lets you design your own workflows. Then you can quickly make
changes whenever needed without compromising software validation.
5. Puts You in an Audit-Ready State
A big part of passing an audit is finding documents to show to the auditor. When
these are kept in filing cabinets or saved on one person’s computer, finding the
document is a hassle. With a connected QMS, finding documents is easy. You can
quickly search and know that the version you’re looking at is the most recent one.
The needed electronic signatures and audit trail are automatically logged and
easily demonstrated to an auditor.
Some of these documents are training records. Despite training requirements,
many companies fail at keeping employees trained and keeping track of the
records. Not surprisingly, training is among the top reasons for receiving an FDA
Form 483. There are two reasons for this. One is that a lack of efficiency, visibility,
and connectedness means employees can’t perform according to industry
standards. The second is that, even when employees are trained, it is difficult
to find the paperwork that proves they were trained. A training management
system alone can’t solve these problems. But with a QMS that has automated
assignments, monitoring, and verifying of training tasks, you can ensure training
happens and that you can easily find the records needed during an audit.
6. Makes Continuous Software Validation a Strategy for
Staying Compliant
Companies doing business in FDA-regulated industries must have documented
evidence that their computer systems consistently perform as expected, a
practice known as software validation. The FDA also requires companies to be in
a constant state of validation, which generally means they must re-validate every
time they upgrade or change their systems. In some companies, validation requires
months to complete and produces stacks of paperwork to prove validation
occurred.
MasterControl is a trailblazer in simplifying and expediting software validation
for our customers. The patented Validation Excellence Tool (VxT)™ uses a risk-
based approach to validate, which is what the FDA itself suggests. VxT lets users
assess the risk to their business based on how they use the software. By relying
on MasterControl documentation and only doing additional testing for high-risk
features, validation can be done in hours or even minutes. With more flexible,
4
 Industry Brief

configurable software, validation needs to continue to evolve. MasterControl is

again innovating with the patented Validation on Demand (VoD)™. VoD lets users
perform next-generation, automated validation testing targeted to their unique
use cases and workflows.

Conclusion
The importance of quality in regulated environments can’t be overstated. An
effective QMS is the foundation of any regulated company’s compliance efforts.
As such, it needs to feature the functionality of a document control system,
training management system, and quality event management system all rolled
into one. This type of QMS doesn’t handle quality as a retroactive process, but
helps organizations continually improve so they can meet regulations and have a
competitive advantage in the market.

MasterControl is an advanced, fully connected QMS and the No. 1 QMS in

the life sciences. With connected document, training, quality event, and audit
management, users can easily manage all aspects of quality on a single platform.
An important part of our QMS is our analytics solution, MasterControl Insights.
Insights lets users easily analyze their data and prepare visualizations and
dashboards. Users can also use artificial intelligence (AI) functionality to avoid
problems before they occur. These features put companies in a unique position
where they can adapt quickly while remaining compliant.

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

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6 Must-Haves for a Quality Management System (QMS) 5