White Paper

The Pros and Cons of

Buying Vs. Building a Quality
Management System
Introduction

Regulated companies that are looking into either buying or building a quality management system (QMS) generally fall under
two categories: the small company (perhaps a startup) that has no QMS at all, or the established company seeking to improve its
existing QMS. There are other types of companies in between, but this white paper will focus on those two.

The small startup (either virtual or brick-and-mortar) usually has only a few employees and no laboratory space or plant
facilities. Almost all of its work is contracted out. This company is not likely to be inspected by regulators anytime soon, but it
will be audited by its customers or potential business partners. As far as QMS is concerned, the goal of this company is to
have one.

The established company usually has a lab and perhaps pilot plant facilities. It has a full staff, including an R&D department.
This company has been inspected by regulators before and undergoes both internal and external audits. It has a manual
QMS that combines electronic tools and paper-based processes. For example, staffers write SOPs and other documents using
Microsoft Word, route the documents via e-mail, review and revise them in Word, then send them back and forth via e-mail until
the documents are approved. The final SOPs are printed, dated, and filed in binders. The signatures of approvers are maintained
in a separate signature sheet that accompanies the documents. While the process is working so far, documents are growing
exponentially; revisions are more frequent; the approval process is increasingly delayed; and the staff is overburdened. This
company needs a better QMS to increase efficiency and to maintain compliance by increasing its inspection readiness.

The main issue for both types of companies (and for most companies in general) is cost. Specifically: Is it more cost-effective to
build a homegrown system or to buy a proven and validated QMS? Which option is cost-effective not just initially but over the
long haul?

Types of Tools

If your company is trying to decide whether to buy or build, start the evaluation process by looking at the different types of tools
at your disposal:

Homegrown System: Developed in-house, possibly with the help of consultants. You may write your own software from
scratch, or use templates as a framework.

Out of the Box: Software that offers little or no configurability.

Configurable Off the Shelf: COTS software offers high configurability with standardized and fully supported base code.

Tool Kits: Technology platforms that require significant design and programming to provide the final solution.

Point Solution vs. Enterprise Platform: While evaluating the tools described above, you also have to consider whether your
company needs a point solution or an enterprise platform.

■■ Point Solution: A point solution addresses a particular need, such as document control or CAPA or complaint
handling. It fixes an immediate problem. Point solutions are offered as out of the box, COTS, or tool kits.

■■ Enterprise Platform: An enterprise platform covers more than one solution. It is large enough to be used not just by
one department but the whole enterprise. It is scalable, configurable, and there is room for adding more solutions and
addressing future QMS needs.

Pros and Cons

After getting familiar with the different tools available, it is time to weigh the pros and cons for each one.

Homegrown System

■■ Advantages: Writing your own software gives you control over the development and expansion of the system. It gives
you leeway in terms of cost, in the sense that you can build the system piecemeal, as funds and other resources
become available.

White Paper: The Pros and Cons of Buying Vs. Building a Quality Management System
 ■■ Disadvantages: When building a system, you have to ask if you are simply reinventing the wheel. You run the risk
of not covering all the bases when it comes to regulatory requirements. Any delay might make the system obsolete
before it is completed. Estimating the time, effort, and money involved in development is not easy because there are too
many variables involved (availability of staff with the right skills, how long they can dedicate themselves to the project
before they are pulled in other directions, etc.). It is not uncommon for organizations to start building a system then
abandoning it because changes (either within the management or within the industry) have made the project moot.
Those organizations end up buying anyway.

Out of the Box

■■ Advantages: This solution is usually inexpensive and easy to implement because it offers little configurability. It does
not vary from one company to another, so it is easy to support and the results are easy to predict. The operative word
here is easy.

■■ Disadvantages: Out-of-the-box solutions are, by nature, simplistic. They are not robust and they often require a
hybrid management approach. For example, the system may allow you to route, review, and approve documents
electronically, but it does not include an electronic signature capability that is compliant with the FDA’s 21 CFR 11
requirements. So in the end, you still need “wet” signatures of approvers. Another big disadvantage is that the lack of
configurability that makes it easy to implement (and inexpensive) also means it is not scalable. Most companies that
use an out-of-the-box tool end up outgrowing the solution and replacing it entirely. So you must look at it as a short-
term investment.

Configurable Off the Shelf

■■ Advantages: COTS solutions offer configurability, allowing companies to address their unique needs without having to
start from scratch in software design and in validating the system. This type of system has a standard code base, which
means the underlying programming is the same for all customers, making it economical and efficient to support. It
offers the flexibility and scalability that a growing organization needs.

■■ Disadvantages: Configurability means it is more complex and may require supplementary training for users.
Compared with out-of-the-box solutions, COTS is more expensive. This type of system is for long-term use and should
be considered a long-term investment.

Tool Kits

■■ Advantages: This is ideal for a process that is unique to an organization and cannot be addressed by COTS. There is a
tool kit for almost any solution that a company might want to establish.

■■ Disadvantages: When you use a tool kit to serve as a QMS, you are essentially reinventing the wheel because the
processes that make up a QMS can be easily provided by COTS. Just like building a homegrown system, a tool kit may
seem inexpensive at first, but the cost of building and validating the system will come later, making it just as expensive
or more expensive than other solutions.

Point Solution vs. Enterprise Platform

Now that you have given the pros and cons of each tool a thought, it is time to consider the advantages and disadvantages of
point solutions vis-à-vis enterprise platforms.

Point Solution

■■ Advantages: A point solution is ideal for an organization with a pressing concern that can be defined apart from other
QMS needs. For example, a pharmaceutical company in the early stage of drug development is several years away from
clinical trial. It may be focusing on its nonclinical research and pre-clinical regulatory submissions. So the company
may want a simple point solution for submissions in the interim. The point solution will address its immediate need at a
relatively low cost.

■■ Disadvantages: Think of a point solution as a Band-Aid. It is meant for a quick fix and rapid implementation of a new
process. As such, companies can outgrow a point solution fast. Some companies use multiple point solutions, but since

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 point solutions offer no connectivity, their users must manually manage the flow of data and their IT departments have
to support multiple platforms. These companies eventually abandon their point solutions—wasting their investment—
and migrate to a tool with broader offerings.

Enterprise Platform

■■ Advantages: An enterprise platform will allow you to address an immediate problem with a point solution and at the
same time enable you to add solutions within the same platform in the future. It can integrate processes and connect
the different teams that manage those processes for a more unified approach to compliance. For example, a serious
deviation will be automatically escalated to CAPA within the system. When the CAPA is approved, it may result in a
substantial change in all relevant SOPs, which in turn may necessitate training on the revised SOPs for all affected
users. An enterprise platform will seamlessly connect the processes (in this case: deviation, CAPA, SOP, and training
management) and all affected users.

■■ Disadvantages: The configurability, flexibility, added functionality, and connectivity of an enterprise platform all
come at a cost. So the only real downside to an enterprise platform is its price tag, which is typically higher compared
with other tools.

How MasterControl Can Help You

Over the years, MasterControl has helped hundreds of companies that have been in a “buy vs. build” dilemma. MasterControl’s
product managers all come from the industry, so they have a keen understanding of the unique challenges that regulated
companies face. They developed MasterControl solutions based on regulatory requirements and feedback from customers.

The result: MasterControl is designed as an end-to-end solution that significantly improves efficiency, accelerates compliance,
and reduces cost by helping users save time and effort. It operates as COTS with an enterprise platform, but it allows out-of-the-
box implementation of a variety of point solutions. Companies may start with a MasterControl point solution but eventually grow
into an enterprisewide system. For companies that prefer the tool-kit route, MasterControl can be used as a platform for entirely
unique processes that cannot be addressed by COTS.

MasterControl as an Out-of-the-Box Point Solution

MasterControl’s out-of-the-box point solutions are based on industry best practices and ideal for organizations that are in the
process of defining their QMS needs in such areas as:

■■ Audit Management
■■ Batch Records
■■ Bill of Materials
■■ CAPA
■■ Change Control
■■ Complaint Handling and Electronic Medical Device Reporting (eMDR)
■■ Design Control and Design History File (DHF) Management
■■ Deviations Management
■■ Equipment Calibration and Maintenance
■■ Non-Conforming Material Reports
■■ Out of Specifications
■■ Supplier Management

MasterControl as Configurable-Off-the-Shelf Enterprise Platform

Hundreds of companies worldwide use MasterControl to manage and streamline critical quality processes such as document
control, risk management, audit, training control, quality event management (complaints, MDR, NCMR, CAPA, deviations,
nonconformances), as well as BOM management, project management, and change control (ECR, ECO).

One of the biggest advantages of using MasterControl is that the system allows organizations to start with a point solution that
can be easily developed into a full-fledged, fully integrated QMS later on. Integrating quality processes under a single enterprise
platform makes a QMS more transparent to users, auditors, and regulatory inspectors. Documents and processes are easier to
review and maintain. Compliance requirements are less likely to fall through the cracks.

White Paper: The Pros and Cons of Buying Vs. Building a Quality Management System
MasterControl is web-based, which means users can access the system from virtually anywhere 24/7. With MasterControl,
users can also access the system using a tablet or a smartphone. This capability is a distinct advantage over other QMS software.
Mobile access is particularly useful to employees who are out in the field or often travel or work off-site. Those users will be able
to participate in quality processes even when they are not in front of their computers in the office, increasing efficiency
and productivity.

MasterControl as a Tool Kit

MasterControl Process™, a component of the MasterControl platform, is a low-cost option for companies with unique processes
that cannot be addressed by COTS. It is particularly effective for any forms-based process or workflow. For example, your Device
History Record process may be unique because your product is cutting-edge and it requires a special method of collecting
manufacturing data, which you have been performing manually. With this tool kit, you will eliminate any paper-based process,
reduce (if not avoid) errors in manual data entry, as well as increase efficiency.

Conclusion

If your company is facing the “buy vs. build” dilemma, you are not alone. Many companies go through the same phase and
undergo a similar evaluation process.

MasterControl has helped hundreds of companies worldwide address their QMS needs—from organizations with as few as 10
employees to corporations with thousands of employees. MasterControl has supported organizations that need only a single
point solution or a tool kit. It has worked with companies that start with a point solution and eventually graduate to a full-fledged
enterprise platform as their operations expand.

So before you decide to buy or build, take advantage of MasterControl’s resources and expertise to help you choose the best
option for your organization, including a chance to learn directly from other companies that have been in your situation before
and are now using MasterControl.

Related Videos

Creating a Paperless Process Using MasterControl

Using MasterControl for FDA Compliance

MasterControl Documents Module

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).

© 2015 MasterControl Inc. All rights reserved.

WPTTRXXUSENLT-04/15

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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.