White Paper

Six Ways to Optimize Y

our Quality Management
System and Ensure FDA
and ISO Compliance
Introduction

How much does quality cost? Most companies would be hard-pressed to translate “quality” into a monetary value –
that is, in real dollars and cents. What they do realize, however, is that a lack of quality could cost millions of dollars in
rework, scrap, recall or even liability lawsuits.

This is especially true in the strict U.S. Food and Drug Administration (FDA) and International Organization for
Standardization (ISO) environments, where quality is closely incorporated in regulations and standards.

The FDA explicitly states that the overarching philosophy of the pharmaceutical Current Good Manufacturing Practice
(CGMP) regulations is this: “Quality should be built into the product, and testing alone cannot be relied to ensure
product quality.”

Similarly, the eight quality management principles that form the basis of the ISO 9000 series of standards articulate the
importance of making quality an integral part of a manufacturer’s daily operations.

Six Ways to Optimize

This white paper proposes that an optimal quality management system (QMS) is the foundation for long-term
regulatory compliance, and ultimately, for ensuring market success. Without a solid quality infrastructure,
organizations are simply not equipped to face the challenges of the regulatory environment and the vicissitudes of a
competitive market. In addition, an optimal system will spare organizations the unnecessary, and often staggering, costs
of poor quality.

MasterControl, a leading provider of quality management software solutions for companies in the FDA and ISO sectors,
offers the following considerations for optimizing a QMS to ensure high-quality products/services and continuous
compliance.

1. Automate Your System to Simplify the Compliance Environment.

Even in today’s business environments, where high technology is increasingly ubiquitous, many companies in the FDA
and ISO sectors continue to rely on paper-based or hybrid (partially electronic) quality systems. According to one FDA
investigator, paper-based systems don’t necessarily pose higher risks, but they are not the most efficient choice for
compliance efforts. A routine GMP inspection typically lasts a week, but it can sometimes last up to five weeks. Within
this context, the investigator said, an electronic record-keeping system could make all the difference in speeding up the
inspection process.

Quality systems are complex and often difficult to manage across an entire enterprise, especially in regulated
environments where strict adherence to quality standards is required. Automating such processes with a QMS can help
increase efficiencies and accelerate product delivery while maintaining compliance.

For instance, the MasterControl™ quality management suite automates all quality-related tasks such as routing,
tracking, escalation, review and approval of documents and forms. Automation helps sustain compliance by simplifying
the compliance environment, standardizing and streamlining processes, and promoting efficiency throughout the
enterprise. MasterControl provides a single repository for all quality documentation, making search and retrieval easy
during inspections and audits.

By simplifying and streamlining processes through automation, an organization can cut down its throughput process by
45 percent, from 11.5 days to 6.3 days. Cycle time can be reduced by 37 percent, from 14 hours to 8.8 hours. Companies
can vastly improve document approval cycle times, reducing the cycle from months to days, or from several weeks to
several days.

White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
2. Choose a Connected Solution for Holistic Quality Management.

If putting a dollar value on quality is difficult, breaking the concept of quality into separate compartments is even more
challenging. Consider the example of a defective medical device, in which a new glucose monitor shows erroneous
readings during testing. An investigation of this product would cover the entire product lifecycle. The manufacturer
would investigate the root cause of the problem through its corrective and preventive action (CAPA) 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), a new training on the approved design changes would be implemented for all employees concerned, and
this activity would be documented and managed through the training control process. All updates in the documentation
for this product would be managed through the document control process. From this perspective, it is virtually
impossible to manage quality separately.

The MasterControl quality management suite provides connectivity on multiple levels:

■■ It connects the different quality processes critical in compliance, such as document control, training
management, change control, CAPA, quality audit, nonconformance disposition, customer complaints and
other processes.

■■ It can integrate with electronic repositories that are good for storing critical documents but are incapable of
controlling quality processes like training or CAPA. It enables companies to leverage their existing repositories
by integrating them with robust applications without expensive custom coding.

■■ It allows the exchange of files and data between MasterControl applications that control specific quality
processes and enterprise systems such as enterprise resource planning (ERP) and manufacturing execution
systems (MES) that are not connected to the QMS.

■■ Its Web-based platform connects different departments and people – even vendors, consultants and other
authorized third parties – involved in quality control, regardless of location.

3. Choose a Solution with Robust Analytics and Reporting Capability for Effective
Management.

In today’s competitive manufacturing environment, organizations must not only ensure product quality, but also have
insight into all quality processes. Those in regulated environments, especially, need all the support they can get to
see trends and understand quality issues in order to proactively solve problems. Their ability to adapt to changes and
problems in a timely manner can make all the difference between a simple CAPA or a product recall.

A QMS can generate a lot of quality data from various groups and cross-functional teams. These data can provide
valuable insights into an organization’s quality processes – but only if the data can be collected, disseminated and
reported clearly and quickly.

MasterControl’s advanced analytics and reporting capability provides standard and customized reports to help increase
management oversight. It includes dashboard, drill-down and advanced scheduling features. It gives managers a real-
time view of quality issues to help them gain insights into how the system can be improved.

Ultimately, it’s better to address quality issues early in the product value chain rather than discover them once the
product is in customers’ hands. Managers without an effective analytics and reporting tool in their QMS are essentially
working in the dark.

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4. Choose a Flexible and Scalable System to Support Change and Growth.

Automating a quality system is a major endeavor in terms of time, effort and cost. Rather than be forced to revamp
their system often, organizations choosing a QMS should take into consideration how the system would support future
growth at three individual levels: users (by the dozens, hundreds or thousands); business units (domestic and/or
overseas); and operations (new products and services). The system must be able to adapt to changes in the market and
in the regulatory environment.

The MasterControl quality suite offers the flexibility and scalability for enterprise quality management across the
entire enterprise – different sites and facilities, multiple business units and different departments – no matter the
organization’s size:

■■ MasterControl’s modular approach allows small start-ups to automate their quality processes using core
applications, and then enhance the system by adding modules as the company grows.

■■ For midsize companies past the start-up phase, a full MasterControl suite can help them cope with changes in
the market and respond to growth opportunities.

■■ For large-scale enterprises that have invested in electronic repositories and point solutions, MasterControl can
integrate with these external applications to complement their functionality.

Because it is Web-based, MasterControl can support a company with nationwide or worldwide operations, and its
scalable infrastructure makes it easy to add more users and increase storage as business needs grow or change.

5. Integrate Training into Quality Management for Continuous Quality Improvement.

CGMP regulations require all those engaged in product manufacturing to have the education, training and experience
necessary to do their jobs properly, including ongoing training in CGMPs. Training is similarly important in the ISO
sector: the sixth quality management principle of the ISO 9000 series refers to “continual improvement.”

Despite training requirements, many companies fail in this aspect, which is why training is among the top reasons for
receiving a Form FDA-483. A lack of efficiency, visibility and connectedness means company personnel are unable to
perform according to industry standards.

An important way for organizations to manage training tasks and related compliance requirements is by providing
employees with continuous training in tools and methods that would promote quality improvement.

MasterControl Training™, for example, makes continuous training easy with automated assignments, monitoring and
verifying of training tasks, as well as grading of online exams. Test results and related documentation that serve as
proof of personnel competency are always ready for inspections and audits. Training control can be integrated with the
rest of the quality system, so any change to a document or process that warrants new training will automatically invoke
training tasks upon approval of the change.

6. Make Continuous Validation a Strategy for Staying Compliant.

FDA-regulated companies with an automated QMS are required to provide documented evidence that their systems
consistently produce results meeting predetermined specifications, a practice known as 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.

For many companies, software validation is difficult and costly, requiring a significant amount of time (often several
months) and expertise.

White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
MasterControl considers validation an integral part of software solutions for FDA-regulated customers, and offers
robust software solutions plus all the tools and services necessary for successful validation. MasterControl’s continuous-
validation approach is meant to make software validation faster, easier and more cost-effective. Following this strategy,
MasterControl offers a line of products and services addressing different validation needs based on individual risk
assessment. These products and services are designed to allow “continuous validation” by dramatically reducing the
time, pain and cost involved in software validation, ultimately ensuring that companies are always ready for inspections
and audits.

Conclusion

Quality can be a “slippery” concept, but a solid quality management infrastructure will make it concrete and easier to
attain and sustain. An effective QMS is the foundation of any regulated organization’s compliance efforts. Optimizing it
in the ways described in this white paper will help companies realize maximum value for years to come.

Related Videos

Why Companies Choose MasterControl

Using MasterControl for FDA Compliance

Using MasterControl for ISO Compliance

About MasterControl Inc.

MasterControl produces software solutions that enable regulated companies to get their products to market faster,
while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company’s critical
information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to
validate, and easy to use. MasterControl solutions include quality management, document management, product
lifecycle management, audit management, training management, document control, bill of materials, supplier
management, submissions management, and more. Supported by a comprehensive array of services based on industry
best practices, MasterControl provides our customers with a complete information management solution across the
enterprise. For more information about MasterControl, visit www.mastercontrol.com or call 1.800.825.9117 (U.S.); +44
(0) 1256 325 949 (Europe); or +81 (03) 5422 6665 (Japan).

© 2014 MasterControl Inc. All rights reserved.

WPXXXXUSENLT–12/14

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Corporate Headquarters: European Headquarters:
MasterControl Inc. MasterControl Global Limited
Salt Lake City, UT Basingstoke
United States United Kingdom
Phone: 1 866 747 8767 Phone: +44 (0) 1256 325 949

Asian Headquarters: Contact information and addresses for

MasterControl KK other regional MasterControl offices and
Tokyo MasterControl partner offices are listed
Japan on the MasterControl website at
Phone: +81 (3) 5422 6665 www.mastercontrol.com.