
I often get asked: “What’s the best software package?” Individuals are usually looking for guidance in selecting a program to manage corrective actions, facilitate document revisions, track equipment maintenance or handle transfer of information about some other processes. With our increased reliance on electronic media, the question isn’t unreasonable. Unfortunately, my response is often disappointing because, as, I often respond, “It depends.” There is no one-size-fits-all software package for all the applications and activities people are looking to enhance, simplify or improve. Software buyers should steer clear of any vendors who purport to have something that works for everyone and does everything. Such a product simply doesn’t exist.
Fundamentally, software programs are electronic versions of conversations, documents, work instructions, drawings, reports, charts, file cabinets and message delivery services. They facilitate interfaces between databases—like those used to track customer complaints and link them to corrective actions. They handle security, interpret or manipulate information, and enable the sorting, filtering and sifting that’s pre-requisite to useful data analysis. They make possible electronic approvals and myriad hyperlinks between documents that may reside on different servers—even at remote locations. In short, they’re one of the conduits organizations use to communicate and control information about their quality management systems.
It’s vital that users select programs and applications that work for their particular organization. Just as with any other tool, it’s important to choose the one that fits the job that needs to be accomplished. The upsurge in inquiries about software packages indicates that people are finally realizing the importance of choosing the right software and recognizing that they do indeed have choices.
There are many factors to consider when choosing software packages. Before discussing these factors, it’s worth mentioning a related QMS process: This is a good time for a supplier qualification process to kick in. Although these companies may not be selling raw material or components, the products they provide will have a huge affect on the your company’s ability to consistently and reliably respond to its customers and deliver product to the marketplace. You may want to assess the supplier’s ability to fulfill your requirements by applying some of the same criteria you use when qualifying other suppliers. The following questions are reliant on the size and complexity of the software that is being purchased.
If the software supplier is designing a system for your company:
- What’s the company’s process for ensuring protection of your proprietary data?
- When can the supplier deliver?
- What’s the company’s process if something goes wrong?
- How does it qualify its employees?
- Does the supplier have the capacity to meet your needs?
- How does it control its design process?
- Does the supplier understand your requirements?
Answers to these questions will tip you off as to whether or not the potential supplier understands even the concept of quality management systems. If you’re not confident the supplier does understand that these are important questions, its software will be comparably devoid of essential QMS interfaces.
Here are just a few things to consider when selecting software programs and applications:
- Complexity of the software package—How large is your organization and how many processes are you trying to link electronically? A company with less than 100 employees may only need a program that links three or four databases and processes. Purchasing a package with features that will never be used is wasteful and confusing.
- Compatibility to existing electronic infrastructure—It’s important to ensure that the purchased product is compatible with legacy software. If your company doesn’t have a dedicated IT person, then some of the questions asked above become much more pertinent. It’s important to have someone who can reliably determine if the new software will work with your company’s existing system and who can provide support when it’s needed.
- Plug-in/add-on modules—If your organization is growing, it might be worthwhile to invest in a system that has programs that can be augmented as needed in the future.
- Sophistication of your staff—Ease of use isn’t to be discounted as a legitimate criterion. It may be politically incorrect, but it’s common sense to concede that some employees just can’t handle a system that’s too complicated.
- Return on investment—Is the system worth the cost? Is your company buying a program that will contribute to a healthier bottom line? The system may help the management of corrective actions, but is it just an elaborate tracking mechanism? Or, is it a system that will facilitate root cause analysis, implementation of a plan and measurement of effectiveness of the actions taken?
- Relevance to your industry—Financial institutions, nuclear plants, hospitals and machine shops all have different processes, products, problems and personnel. Lot traceability of hazardous material may be critical for a chemicals manufacturer, but it’s irrelevant to a hotel chain.
These are just some of the considerations when choosing a system that will handle some portion of your documentation and data management requirements.
So, the next time your boss asks you, “What’s the best software package?” reply, “It depends.”
About The Author

Denise Robitaille
Denise Robitaille is the author of thirteen books, including: ISO 9001:2015 Handbook for Small and Medium-Sized Businesses.
She is chair of PC302, the project committee responsible for the revision to ISO 19011, an active member of USTAG to ISO/TC 176 and technical expert on the working group that developed the current version of ISO 9004:2018. She has participated internationally in standards development for over 15 years. She is a globally recognized speaker and trainer. Denise is a Fellow of the American Society for Quality and an Exemplar Global certified lead assessor and an ASQ certified quality auditor.
As principal of Robitaille Associates, she has helped many companies achieve ISO 9001 registration and to improve their quality management systems. She has conducted training courses for thousands of individuals on such topics as auditing, corrective action, document control, root cause analysis, and implementing ISO 9001. Among Denise’s books are: 9 Keys to Successful Audits, The (Almost) Painless ISO 9001:2015 Transition and The Corrective Action Handbook. She is a frequent contributor to several quality periodicals.