Compliant. Connected. Complete.

White Paper:
Six Ways to Optimize Your 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 dollars
and cents. What they 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 FDA and ISO environments, where quality is closely incorporated
in regulations and standards. The FDA explicitly states that the overarching philosophy of the 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 for Optimization

This white paper posits that an optimal quality management system is the foundation for long-term
regulatory compliance, and consequently, for enduring market success. Without a solid quality
infrastructure, your organization is 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 you
the unnecessary, and often staggering, cost of poor quality.

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

(1) Automate Your System to Simplify the Compliance Environment.

In this Age of High Technology, many companies in the FDA and ISO sectors continue to rely on
paper-based and hybrid (partially electronic) quality systems. An FDA investigator once said that
although paper-based systems don’t necessarily pose higher risks, they are not the most efficient choice
for compliance efforts, either. A routine GMP inspection typically lasts a week, but sometimes they
can last up to five weeks. The investigator noted that within this context, an electronic record-keeping
system could make all the difference in speeding up the inspection process.

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, one MasterControl customer has
reported cutting down its throughput process by 45 percent, from 11.5 days to 6.3 days. Cycle time was
reduced by 37 percent from 14 hours to 8.8 hours. Other MasterControl customers have reported vastly
improved document approval cycle times, reducing the cycle from months to days, or from several
weeks to several days.

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(2) Choose a Connected Solution for Holistic Quality Management.
If putting a dollar value on quality is hard, breaking the concept of quality into separate compartments
is even harder. Let’s take the hypothetical example of a defective medical device, for example, a new
glucose monitor, which showed erroneous readings during testing.

An investigation of this product would cover the whole spectrum: from the R&D process to
manufacturing operations. The manufacturer would investigate the root cause of the problem through
its corrective action/preventive action process. 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 concerned employees, 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 is especially designed to connect people, data, and
processes throughout the enterprise for a holistic approach to quality management. MasterControl
provides connectivity in many 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 has the ability to integrate with electronic repositories that are good for storing SOPs, engineering
drawings, and other documents, but are incapable of controlling quality processes like training and
CAPA. MasterControl allows companies to leverage their existing repositories by integrating them
with robust MasterControl applications without expensive custom coding.

• It allows the exchange of files and data between MasterControl applications that control specific
quality processes (CAPA, training, change control, etc.) and enterprise systems such as ERP, PDM,
and MES that are not connected to the quality management system.

• 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.
Managers without an effective analytics and reporting tool are essentially working in the dark. 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 an expensive recall.

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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 on how the
system can be improved.

(4) Choose a Flexible System to Support Change and Growth.

Automation of the quality system is a major endeavor in terms of time, effort, and cost. You don’t want
to have to revamp your system often. When choosing a software solution, you must consider how the
system would support future growth in three 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 is an off-the-shelf, scalable, configurable, and flexible solution
ideal for regulated companies. Its modular approach allows a small start-up company to automate its
quality processes using core applications, and then build up the system by adding other modules as the
company grows.

For midsize companies past the start-up phase, a full MasterControl suite would 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 has the ability to integrate with
these external applications to complement their functionality. MasterControl is Web-based, so it can
support a company with nationwide or worldwide operations.

(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 to do their jobs properly. They also need to have ongoing training in CGMPs. While
this requirement sounds simple, many companies fail in this aspect, making training one of the top
reasons that companies receive a Form FDA-483.

Training is similarly important in the ISO sector. The sixth quality management principle of the ISO
9000 series refers to “continual improvement.” One way of achieving this is by providing employees
with continuous training in tools and methods that would promote quality improvement.

MasterControl Training™ makes continuous training easy by automating assignment, 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 will always be ready for inspections and audits. This
solution allows sequencing of training courses, so after a prerequisite course is completed, the next one
is automatically launched. 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.

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(6) Make Continuous Validation a Strategy for Staying Compliant.
FDA-regulated companies with automated quality management systems are required to provide
documented evidence that their systems consistently produce results meeting predetermined
specifications, a practice known as validation.

For many companies, software validation is expensive and challenging because it requires specialized
skills and a lot of time (typically several months). 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.

MasterControl considers validation an integral part of software solutions for FDA-regulated customers.
It 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. Under 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.

Conclusion
Quality can be a “slippery” concept, but a solid quality management infrastructure will make it
concrete, and easier to attain and sustain. Your quality management system is the foundation of your
compliance efforts. Optimizing it in ways described above will help you realize maximum value for
years to come.

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About MasterControl Inc.
MasterControl Inc. has been at the forefront of providing quality management software solutions since 1993. Hundreds of
companies worldwide use MasterControl to help ensure compliance with FDA regulations such as 21 CFR Parts 11, 210-
211, 820, 606; ISO quality standards such as ISO 9000, ISO 13485, ISO 14000; and Sarbanes-Oxley Act requirements.
In addition to providing off-the-shelf products, MasterControl also offers comprehensive technical and customer support,
including product training, implementation, and validation services.

For additional industry white papers about automating quality and regulatory processes, visit www.mastercontrol.com,
or call, 800-825-9117.

MasterControl’s integrated quality management system helps connect quality processes enterprise-wide. The solution
provides automatic triggers to ensure tasks for handling quality-related incidents don’t fall through the cracks.
MasterControl’s integrated architecture ensures that the completion of one system process automatically launches the next
quality sub-system until the process loop is closed. Managers have analytical and reporting capabilities at their fingertips
to track and manage each quality process through completion.

© 2006 MasterControl Inc. All rights reserved.

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MasterControl Inc.
6322 S. 3000 E. Suite 110
Salt Lake City, UT 84121

P. 800.825.9117
F. 801.942.7088
www.mastercontrol.com