Technology Approaches to

Quality Management
WHITE PAPER
 Organizations in highly regulated industries continue to face pressure to maintain the highest level of quality in every facet of their
operations. These pressures stem from a number of different areas including a wide range of international regulatory authorities, global
customers and other key stakeholders. More recently these same organizations have been faced with increasing economic pressures
to increase operational effectiveness and efficiency while still being tasked with maintaining an optimal level of quality. These
economic pressures are not based solely on making efficient use of full-time equivalents, but also include managing the total cost of
ownership for software applications that support the business.

The presence of software solutions in the quality arena has progressed gradually from a deployment of tactical point solutions to
complete, enterprise-level solution offerings. Many organizations now receive dramatic benefits from these enterprise-level quality
systems, which extend across multiple areas of the manufacturing process. These benefits are realized from the implementation
of automated, highly interactive quality processes tailored to closely align with each organizations specific products and business
practices. These holistic quality systems are also made more efficient and effective through interactive integration with other existing
enterprise-level software solutions.

Total Solution Offering

Many companies suffer the pains of having adopted a number of different point solutions with modular approaches over many years.

These pains include:

Deployment of modular software with inflexible, purported best practices resulting in limited user adoption and superfluous,
manual workarounds outside the system
Extensive training programs to qualify employees to utilize multiple siloed systems

Lack of closed-loop traceability between processes that are highly related, but in fact reside in separate software systems or modules

Significant number of personnel to support multiple software applications

Complexities of maintaining both hardware and supporting software such as operating systems, application servers, databases,
reporting applications, etc.
Repetition in integration with other software systems serving as a barrier to interactive integration with enterprise applications

Exposure when being audited and inspected resulting in a intensive preparation and manual manipulation to create useful output for
review from disparate silos

When an organization embarks on its software selection process its essential that the organization takes a holistic view of all
processes, as well as the parts of the organization that touch those processes. This is not a one-size-fits-all exercise, but rather a truly
analytical process that each organization will need to undertake before deciding on the solution that will offer maximum scalability
and integration with its core processes. The type of products manufactured along with the manufacturing and distribution model
a company utilizes will have a significant impact on the conceptual design of the companys quality processes. The presence of
other enterprise applications, as well as the extent to which they are currently used, will govern both the breadth of the processes
of the Enterprise Quality Management System (EQMS) and the extent to and manner in which it is integrated. The companys goals
for the selected software should be to provide a complete solution across the breadth of usage identified and to support the level of
integration needed to support a truly efficient, seamless user experience and workflow process.

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Begin with the End in Mind
A point solution or single module may seem to be the viable solution that can stop the bleeding. But history has shown that the
companies with real strategic vision and direction make the wise investment in a solution that can grow along with their needs.

One common mistake occurs when a point solution or modular system is taken at face value for the initial application and the
company fails to take a deeper dive into the long term need. With an enterprise-focused system, this deeper dive is rendered
unnecessary. These products are built with growth and expansion in mind.

Therefore it is necessary in the early stages of implementation to start mapping out what the complete solution will look like for the
long term. The initial deployment typically takes care of the most critical need for an organization. From that point, a strategic focus on
holistic EQMS will drive solutions at each level in the company.

The total cost of ownership for this type of system is ultimately lower because of the enterprise focus around which it is built. The cost
associated with multiple point solutions or multiple add-on modules is often not fully realized until it is too late. Many companies
buy into a solution early to fill a single need and because the substantial investment was made, they are often forced to continue the
commitment to that software even though it was not purposefully built for the enterprise.

Why is all of this important?

This boils down to one thing: COST. In the current economic environment, companies simply cannot afford to incur unnecessary
costs. These costs come in many forms, and some of the more significant considerations are discussed below:

Software should have the ability to easily scale, or significant customization and/or hardware expenses may be required.

As you add modules there will be substantial software validation needed while an enterprise system has already been fully validated,
and you are simply expanding the usage.

Modules often do not look or feel like a single solution, because they are in fact different parts of software code pieced together.
With this, there will be additional training expenses and a soft cost in the form of end user frustration.

The cost of professional services is significant when launching a new module as opposed to choosing in-house configuration of an
enterprise system to incrementally support changes in the business needs as they occur.

The launch of a module typically includes a wholesale change in business and comes at a significant expense, while an enterprise
system can add gradual changes to ease the impact from a user standpoint at virtually no cost

Modular systems may have low initial price points, but as you add modules and functionality a la carte, their total cost quickly
surpasses that of a complete enterprise system.

The final cost stems from risk. There is significant risk involved with customization vs. configuration and module interconnectivity
vs. an enterprise platform. This cost is difficult to quantify until it has been incurred. For this reason companies prefer the lower risk
option.
To learn more about this topic and how Sparta Systems can help, visit www.spartasystems.com

Sparta Systems, an industry pioneer and leading provider of enterprise quality management software Global Headquarters
(EQMS) solutions, enables businesses to safely and efficiently deliver their products to market. Its 2000 Waterview Drive
Hamilton, NJ 08691
TrackWise EQMS, a trusted standard among highly regulated industries, is used by quality, manufacturing
(609) 807-5100
and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the (888) 261-5948
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