Developing a QMS: Should You Buy or Build?

Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems.

Either way, an organization must ask itself: 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?

You also have to consider whether your company needs a point solution or an enterprise platform. A point solution addresses a particular need (e.g., document control or CAPA). It's offered as out of the box, COTS, or tool kits. An enterprise platform covers more than one solution and it is large enough to be used by an entire organization.

Building a Homegrown System

""Building"" a QMS means you will develop the system in-house, possibly with the help of consultants. You may write your own software from scratch, or use templates as a framework. Writing your own software gives you control over the development and expansion of the system. In terms of cost, you can build the system piecemeal, as funds and other resources become available.

While building offers flexibility, there are key issues involved. First, you run the risk of not covering all the bases when it comes to regulatory requirements. Second, you must have staff members with the right skills and experience who can devote themselves to the project. Otherwise, any delay might make the system obsolete before it is completed. Third, even though a homegrown system seems inexpensive, the cost can quickly add up when you consider the number of people and the time and effort the project would require. It is not uncommon for organizations to start building a system then abandoning it because unexpected changes have made the project moot. Those organizations end up buying anyway.

Buying a QMS

If you're considering buying, you must familiarize yourself with the different types of tools available in the market: out of the box, configurable off the shelf (COTS), and tool kits. You also have to consider whether your company needs a point solution or an enterprise platform. A point solution addresses a particular need (e.g., document control or CAPA). It's offered as out of the box, COTS, or tool kits. An enterprise platform covers more than one solution. It is large enough to be used by an entire organization. It is scalable, configurable, and there is room for adding more solutions and addressing future QMS needs.

The next step in your evaluation process should be to weigh the pros and cons of buying a point solution versus buying an enterprise platform, factoring in your specific needs and your budget for the project. In general, however, a point solution is ideal for an organization with a pressing concern that can be defined apart from other QMS needs. The point solution will address the problem right away at a relatively low cost.

An enterprise platform will allow you to address an immediate need 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.

Think of a point solution as a quick fix and enterprise platform as a long-term investment. To get the best of both worlds, find a system that will let you start with a point solution then expand it as an enterprise platform.