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 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.

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.

White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
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.

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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.