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How to vet an eQMS part 2 Blog Featured Image
Lexi Sharkov12/12/233 min read

eQMS 101: How to vet a potential eQMS - Part Two

An eQMS is no small investment, and while ripping and replacing a faulty system is doable, it’s better to get it right the first time around. That means you want to seriously vet each potential partner – a.k.a ask a lot of questions. 

In part one of our “How to vet a potential eQMS” series, we covered the questions you need to ask about configurability and ease-of-use. In part two, we’ve gathered up the questions you can’t skip when it comes to support and account cancellation. Add these to your list before your next eQMS demo or sales call to help determine if the system is the right fit for your team. 

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Questions to ask about support

Support matters. Everyone gets stuck sometimes, and even the very best software can stump a user.  What if you have a surprise audit? Or, you decide to change your process and need help/assurance on a new configuration? What if one of your colleagues just needs a little help and you aren't there? You should be able to count on your eQMS support team, and you certainly should know how it affects pricing.

A vendor’s support team becomes an extension of your team, so evaluate their support capabilities with the same diligence and seriousness as the rest of the technical evaluation. When you’re comparing system, these are the support-focused questions you’ll want to ask:

  • What are the hours of the help desk? Can it support staff in other time zones?
  • Can the company provide any metrics from helpdesk (resolution time, satisfaction scores, etc.)?
  • What are the average response times? 
  • Does the company provide a Service Level Agreement (SLA) for response times and escalations?
  • What costs are associated with implementation? How is it staffed and how rigid is the plan?
  • What are the costs for ongoing support for different kinds of requests? Be specific:
    • Small vs. ‘large’ tickets
    • Document or data import requests
    • Configuration changes (e.g. adding a new CAPA process)
  • Is the software knowledge base updated, organized, and easy to navigate? 

Questions to ask about account cancellation

No one likes to talk about [software] breakups, but it should be a critical part of your evaluation. What if you get acquired or simply need to make a change? What if the vendor goes out of business? A lot of eQMS vendors will talk about how easy it is to get started, but they tend to sweep the barriers for transitioning off of a platform under the rug. 

Skipping this part of your vetting process can lead to some unpleasant surprises if ever you need to switch eQMS platforms (think massive fees to get your documents off of the system or lack of document access entirely). 

Beyond cost, also think about the access timeline and data export formats of your compliant data – all of which can create data integrity issues. To compare how each eQMS platform handles breaking up, ask these questions: 

  • What is the cancelation policy and where is it documented?
  • What are the fees associated with cancellation?
  • How much advance notice is needed for account cancellation?
  • What is the transition process and how can I ensure data continuity?
  • In what form will I receive my metadata and exported, signed documents? 
  • Does this suit my needs in an exit scenario or require additional processing?

A final word of advice: do reference checks! Case studies can be helpful, but also find out what real customers say about working with the vendor. Call any provided references or anyone you know that has worked with the vendor and ask some basic questions about their experience with the software AND the staff.

Curious what quality functions to look for in an eQMS? Need to know how much an eQMS actually costs? Get more insight in our free eQMS 101 eBook for quality pros.