Top Nine Signs your Compliance/EQMS Software Platform Needs to be Replaced Immediately

Having spent the last 22 years of my career working on Compliance/EQMS solutions and platforms, dealing with many software vendors, hundreds of suppliers and thousands of customers, the below signs are by far the most painful, most expensive, and counterproductive factors that impact any QMS/Compliance, platform user:

  1. Complexity: if your Compliance/EQMS platform is complex to use, difficult to administer, difficult to change when and as needed, then there is a big chance that you need to reconsider your choices.
  2. Limited or No Configurability: No two companies are alike and the era of “One size fits all” is over, organizations need to be able to configure their software systems to match their identity, to promote their brand, and to simplify operations and task executions as per their process and not as defined by the software vendor. Operations excellence requires those who are most capable and knowledgeable to spot improvements for a process and be able to inject those changes immediately and without having to go back to the software vendor.
  3. Difficulty of Promoting Configurations: introducing configurations and making changes are never done on a production environment, the right practice which comes from the Life Sciences industry is to have three environments (Development/QA/Production) where changes are made in Dev. and then tested in QA before being promoted to Production. Most software vendors suffer in creating a process/tool for users to allow them to move configurations/changes that they have made across the three environments seamlessly and instantly, it makes no sense for admins. to spend weeks making the changes only to be faced with a challenge that moving such changes will require the intervention of the software vendor for days (lucky) and weeks (most likely) to move changes across using an error-prone process and tool or worst yet, manually.
  4. Destructive Upgrades: if the process of obtaining the latest and greatest updates to your software is not instantaneous then you are missing out. If you are placed in queues for months to be able to upgrade and worst yet charged for it, then you are cheating your company and users, and the worst part is that after waiting for several months and paying for it, the upgrade ends up being a disaster that had left you without all the configurations you have made and the data that you added and the best wish you can make is for the software vendor to roll back your system and bring it to what it was before this upgrade misery.
  5. Performance Bottlenecks: in today’s world, systems need to scale and allow users (millions of them) to access the software around the clock and across the globe. The last thing you want is to have all system users impacted by a single user who is, for example, generating a big report. The worst problem that users suffer from is when the system allows you to make poor changes that lead to performance issues impacting all users by bringing down the system for all, this makes admins. very strict in allowing changes and injecting improvements which result in lost efficiency and innovation hurdle.   
  6. Not True SaaS: if you are not on a SaaS platform, you are probably reshifting your focus and efforts from improving your business to managing infrastructure, chasing security holes, spending too much time and effort on upgrades. There are many reasons for demanding your Compliance/EQMS system to be SaaS, the most obvious ones are: time to value, security, reliability, flexibility, accessibility, simplicity, and cost.
  7. Absence of Collaboration: if your Compliance/EQMS platform does not allow you to collaborate with external parties (outside of your employee base) such as suppliers, vendors, and consumers then your system is behind. Collaboration without having to install many disintegrated systems is key to a successful software implementation. You ought to be able to assign CAPAs, for instance, to your suppliers and receive your product consumer complaints using the very same system.
  8. Coding/Scripting: If your software vendor has left you with thousands of scripts and unmanaged code right after the implementation, and every time you need to make changes to your applications you need to contact your software vendor’s support or open a service order with them, then your system is old and not flexible enough. Admins., Power Users, and Process Owners should all be able to build applications, automate processes, and make all kinds of changes without having to write any code/scripts or need programmers.
  9. High Cost: some organizations tend to prefer paying hundreds of thousands for the software upfront and continue paying TS & Maintenance as long as they are using the software, the truth is that TS & Maintenance fees should be enough to cover your SaaS Compliance/EQMS system without the upfront costs, this way if the software is not delivering what it promised to deliver then the choice of switching is a No brainer. Many organizations feel stuck today due to the hefty investment they made in purchasing their legacy software, they should not. Continuing with such systems will cost you even more. Just eat your loss and move on.

SaaS has made it easy to select the right fit for your software needs, you no longer need to be a hostage of a selection made years ago that does not fit anymore, for a system that is complex to use and heavy to maintain. Continuous improvements or the ongoing efforts to improve products, services, and processes mandate that you implement the right software to support such efforts, a software that allows you to make timely changes easily and seamlessly. If you are suffering from a single factor from the above list, you should be motivated to rethink your choices, if you are suffering from 4+ of the above factors, then you owe it to your company and to your users to stop what you are doing and look for a platform that works.E

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