Don’t Be Shortsighted When Evaluating eQMS Solutions

Don’t Be Shortsighted When Evaluating eQMS Solutions

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company

As a Sales Engineer for over a decade, I continually engage with clients through every step of the sales cycle, from the initial inquiry and Request for Information (RFI) phase, all the way beyond the selection of software solutions. Over the years, I have observed companies engage in a tremendous range of software selection strategies.

Distilling down all of those observations has revealed the one main factor that I truly believe creates a successful evaluation process, one that establishes a lasting partnership between a client and a vendor. That factor is whether a company enters into the evaluation process with a long-term vision for organizational quality versus simply conducting a point solution selection.

Establishing an effective evaluation process

“Rome wasn’t built in a day.” Too often, companies evaluate a single quality process through a myopic lens, looking for a short-term solution to a single pain point. This can lead to massive disruption within those organizations in the long term. They end up managing multiple disparate systems, resulting in a lack of harmonization and a confused end-user base. Typical fall-out includes systems that don’t speak to each other or are expensive to integrate and maintain, the need to train users on multiple systems, and the tedium and cost of keeping the various systems up to date.

It is completely understandable that not every company has the budget or timeframe to implement an entire enterprise-wide Quality Management Systems (QMS), and may just need a single process at a particular moment, but the selection approach should still factor in the long-term quality vision of the enterprise. By mapping out the direction and a 3-5 year “Quality Plan,” a company can appropriately evaluate the EQMS vendors within a given industry space.

So how does a successful company begin that journey? I have noticed some general concepts that have proven effective on a consistent basis.

Step 1 – Form an evaluation team

The first step is to create appropriate teams both for the evaluation and the decision making process, as well as to establish which party makes the final decision – ideally, Directors and Managers, with Executive Sponsorship, and contributions from the broad employee population. Sometimes companies blur these lines and grant too much influence too low in the organization without proper executive involvement. Yes, end users will have to work with the software day in and day out, but there are a few problems with end user-based decisions void of appropriate management involvement and executive sponsorship.

One issue is that pure users are simply thinking of what makes their specific tasks easier. They are not necessarily looking at the broader view or vision of what is in the best long-term interest of the company. The other problem is that in 3-5 years, the composition of that user population will likely not be same. By creating appropriate evaluation and decision-making teams up front, the company will launch a well-organized process.

Step 2 – Prioritize quality needs

The second step is to outline the quality needs of the organization and prioritize those into Year 1, Year 2, and Years 3-5 buckets. This is a tough task because, as we all know, quality permeates throughout an organization and is integrated with every facet of a company. In Year 1, companies typically tackle and resolve their immediate pain points, but Year 2 and Years 3-5 become a little trickier.

“We didn’t know an enterprise quality system would address that specific process and we just purchased a point system for that.” I can’t tell you how many times I have been in a solution demonstration and heard that comment as I presented the myriad capabilities embodied in a true enterprise QMS.

By listing out all the processes that contain quality management elements within an organization (such as nonconformances, CAPAs, complaint handling, audits, inspections, documentation, training compliance, etc.), and the software currently in use, you will paint a good landscape of the company’s quality system needs. This should be done in great detail with input from all departments, because what you will uncover is that additional areas of the company not previously considered may have needs that also can be addressed through an enterprise QMS.

Step 3 – Secure a budget

Once all the information has been gathered and needs have been prioritized, it is just an exercise of projecting and securing a project budget to span out over years 1, 2, and 3-5 that will meet the costs of your selected vendor and allow you to meet all of your quality management goals. This is why it is imperative to have upfront executive sponsorship and their commitment and support throughout.

Selecting a provider

Selecting a provider that will allow you to meet all of your quality management goals might seem overwhelming. Where do you start? What are the common elements among QMS vendors, and more importantly, what are their unique capabilities?

For answers to these questions and insights into the factors that can impact your vendor selection, be sure not to miss next week’s Pilgrim Blog that will focus on Step 4 – Selecting a QMS provider.


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