Seven Considerations
Choosing Software for Quality and Compliance Management

In today’s dynamic and demand-driven market, the need to implement enterprise technology to keep pace with rapidly evolving operational, production, and compliance environments is key to success.

That’s one conclusion of a white paper from EtQ titled “An Insider’s Guide to Selecting a Quality Management Software System: Thoughtful Considerations for Selecting the Right Solution for your Business.” The developer of quality and compliance management software says that in recent years, enterprise technology has become more prevalent in its penetration of all operational areas within a business.

It has become so prevalent that it is rare to find a department within an organization that does not have a dedicated enterprise software solution to provide some level of support.

In recent years, enterprise software solutions have become commonplace in many organizations, whether integrated Quality Management Systems (QMS), or Quality Management modules within larger production systems, even down to simple point solutions for Document Control or Corrective Action.

Recent reports on top software components for organizations show that Quality Management is at the top of the list. In many organizations, Quality Management and QMS systems are a strategic priority. As demand for these solutions grows, so does the vendor landscape — more software vendors are providing solutions for quality and compliance management than ever before.

With a high demand and a large vendor landscape, it sometimes becomes difficult to discern which systems provide the greatest value and guarantee a successful implementation. Many organizations will spend a considerable amount of time and effort in selection of such systems — hiring consultants and assembling selection teams, months of demonstrations and negotiations.

There are many systems in the market today, all with various levels of functionality and features. Some vendors focus on a specific niche, some are more generic. All of them have similar features, but in many cases selecting the right vendor falls into a single requirement — what is right for your business.

Seven Considerations

Some vendor features to consider include: 1. Flexibility: Beware of systems that claim flexibility, but are limited in the depth of configuration to meet your needs. Do not compromise; have the vendor use your business processes and configure a few sample workflows and forms related to your business.

2. Web-Based versus Web-Enabled: Keep an eye out for systems that claim they are Web-based, but use middleware to accomplish the task. This type of “Web-enabled” interface can cause functionality issues, and make for difficulties in retrieving, searching and integrating data. Make sure the system is a truly Webbased system and uses a single technology to accomplish the task.

3. Look and Feel: Look for systems that are able to match your company’s branded image, without programming. Many systems will claim their configurations can be made to the look and feel, but often fall short in allowing layout changes. Having a system match your company’s look will make the system less foreign to the end user, and make them more productive and comfortable with the system.

4. Reporting: Make sure the system has robust reporting and searching tools, so that you can find data and trend data with ease. Many vendors will claim they have reporting tools, but through a third party license agreement, driving up the cost of the system.

Furthermore, make sure that the system can generate the reports you want – without proper reporting the data becomes useless to you.

5. Integration: Systems that can integrate across your enterprise can dramatically improve operations. Look for systems that can integrate data from production systems and push and pull data, providing true real-time communication.

Many systems can fall short of advanced integration, and usually have limitations. Consider the systems you interact with and ask for a demonstration on how the vendor plans to integrate with your other systems.

6. Scalability: Whether it is an immediate need or a long-term goal, factor in the ability to scale to multiple facilities, contract manufacturers, suppliers and customers. Many vendors offer highly customized “workarounds” to manually sync data from one site to the next, sacrificing real-time visibility and standardization in the process. Look for systems that are able to provide a central location for managing locations, sites, keywords, access rights and processes — ensuring each facility is able to conduct business in their terms, but provide a realtime rollup of data to the enterprise.

7. The End User Experience: Consider your end users when selecting a software system. End user productivity is key to a successful implementation, and comfortable users are happy users. Many vendors do not understand quality and compliance as you would, and develop products that are functional, but not end user friendly. Look for configurable systems that can match a look and feel of familiar systems in your organization, or even mimic legacy systems you are replacing. Simple colors and styles can make the difference.

Finally, look for a vendor who understands your business — For example, a vendor primarily focused on pharmaceuticals may not know what a discrete manufacturing process will entail and vice-versa. Look for vendors who have a background in your industry and see how their product will map to your business.

As you go through the selection process, consider these points, but more importantly, make sure that you build a list of requirements for your system.

Having a well-defined set of requirements will provide you with the guide to evaluate a software system. If they are able to meet your requirements, then there may be a fit. Finally, do not be afraid to make the vendor prove their solution to you. Request proof of concept demonstrations, have them configure your sample business process, and pose tough questions. If they are able to respond to your requests, then you can mitigate any risks of a bad investment and ensure a successful implementation. FSM

 Excerpted from an EtQ White Paper, “An Insider’s Guide to Selecting a Quality Management Software System: Thoughtful Considerations for Selecting the Right Solution for your Business.” To learn more, go to www.etq.com.