How to choose QMS software for your company?
Market is crazy and everybody is racing to stand out from the crowd — we know this. But did you know that invention is not dead? I’m talking weekly with 15–20 new startups, who have some cool invention and want to reach compliance and market their solution as fast as they can. Having a good organizing method is a key for every business. Following a simple paper-based method will not do the trick today, if you want to stand out from the crowd, you must arm yourself with tools that improve your skills. This is even more so true if you are aiming to implement QMS standards over your company. In order to save a lot of time, effort and money it might sound strange at first but the best option is to find good QMS software and invest in it. At first it might look as an extra unnecessary expense, but I guarantee that if you start your work on a paper-based method, pretty soon you will feel left behind compared to those folks who were brave enough to take the bullet and invested in QMS software, it pays off on the long run. Actually, it pays off pretty quick. The market is full of QMS software vendors; they offer different tools for different needs. You have to find the right match. First determine your requirements, and then see if the QMS vendor is a fit. How to determine your requirements? What are the basics that every QMS software should have? How to choose software that will speed up your QMS implementation, enhance the quality of your operation, help to reach compliance and market your solution faster?
In the following, I will lay out basic guidance, share some extra insights and tips of the hidden topics of the vendors, and take notes because when you read this you’ll be able to evaluate any software vendor in no-time.
Match the software size with your Company size
The first category is very easy to follow: choose software that is appropriate to your company size. This means: if you are a startup who is small in size, you have to look for a software vendor who is specializing their offer for startups. If you are a large company with a large/medium sized team, and the software you choose is intended for small companies, the system may slow down your work, or worse -it might break-down on you, because it was simply not created for a large number of users. The rule works vice-versa as well, if you are a startup and you chose enterprise level software, you will end up with unnecessary expenses- that is painful enough, plus the software might slow down your operation and confuse your team with unnecessarily feature burdens- and that will kill the moral at the start.
Take away: look for appropriate-sized software that has just the right number of features, plus scaling abilities, so as you grow it will grow with you.
Transition/QMS Implementation Process time? Templates can help?
I would divide this part into 2:
a. For those who have a paper-based QMS and want to transition to eQMS
b. For those who are just starting with the implementation — early beginners.
a) For the first group, it is important to know how long will the transition take, how long it will take to import your documents into the software, is there an option for mass-import, how to implement your existing processes in the new software, etc? Second advice is to look at the vendor’s method for: documentation maintenance, approval system, revision history, etc. Check if the software is cloud based, and don’t be afraid to ask what level of security your data would have. Take all the above mentioned in consideration and ask how long it usually takes for companies like yours to implement their QMS with the help of the software? Do you have to import everything, or you can have a hard-transition date and just import the necessary in order to continue? Do they offer any consultancy help on this topic? Ask anything that is specific to your company, for example: if you have an inhouse documentation numbering that you would like to keep and continue in the software, ask if it is possible with their software?
Extra tip: ask the software vendor what help do they offer as part of the onboarding process?
b) For total beginners usually the most important is to have a quick start, for this the biggest help can be the various template packages that a software vendor might offer. Check for free set of SOPs, prefilled forms that follow your required standards, procedures, processes, Quality Manual, etc. Don’t forget to ask for the validation documentation either. Also ask if the software vendor is offering any inhouse QMS consultancy help, when you are in an early startup-phase any help is highly appreciated. Ask them to break-down into step-by-step what initial work you will have to do to in order to get the software ready for work? (For Example: import users, define user groups, set up approval workflows, define standard specific System-Operating-Processes, define workflow processes that also follow your specific standard requirements, what templates do they offer -do they have a Quality Manual, do they offer a system validation documentation set?, etc.)
Many of you asked if I had a specific recommendation regarding QMS software vendors that would fit the needs of a total startup MedTech company? In my day-to-day activities I have to work with many QMS software vendors, and I can confirm that there are many good software out in the market, if I would have to name one software that is specialized in helping MedTech startups to reach ISO 13485 and FDA compliance (both Europe MDR and USA), I would name qmsWrapper, primarily because of the feature set that is fairly covering the needs of a small/mid -sized company, and also because of the price-range. The software comes with a comprehensive set of: processes, templates, forms, an editable Quality Manual for ISO 13485 MDR, and a set of validation documentation, this is all you need to speed up your QMS implementation from the beginning.
Get everybody on board/ Training
Implementing a QMS standard might sound painful at first, especially for those team-mates who never worked towards a standard compliance before. The most important is to have the management on board, if you don’t have the support of the management, the QMS implementation is doomed to fail. Once the management agrees to implement an electronic QMS system for documenting/coordinating the daily QMS activities, the team will follow. Of course, every new system requires some discipline to follow, the QMS manager will have to carry the burden of pushing everybody to use the software. This might be especially difficult with those work-mates who have never used software of this type before, or who had previous bad experience. With the right training method these obstacles might be solved quickly; ask the software vendor what Training they offer for your team, ask if you can access their best practices knowledge-base to learn from the example of similar-to-your companies. Ask the vendor what do they offer to speed up the learning curve for using their software, do they have a time-line they will hold your hand, and what is the extent of their help, do they charge extra for onboarding trainings, second level trainings, etc?
Take away: Training is very important, the support that the QMS software vendor offers is equally important as the feature-set they offer. Extract as much of free help as you can.
Features, users, storage, scaling cost?
We touched the importance of the appropriate feature set in the second chapter of this article, but when negotiating with the QMS software vendor there might be some hidden matters. Ask the potential software vendor of the intended use of the software, what are the features the software offers and whether you need them all at your stage? Do they offer any consultancy help on this specific matter? Will there be additional charge to add more features as you grow? Is there any additional fee for more storage space? What is included in the basic offer of the software and what are the additional costs, are there any hidden costs? The basics should be: Managing documentation (automatic version control, document approvals, detailed revision history, electronic signature), process automation, CAPA, Risk, audit management, etc.
Price/Hidden costs
Price is a particularly significant item; let it be small or mid-sized organization, all along the way. You should ask the potential vendor to list what is included in their basic offer. For example: Is each module purchased separately and is it paid annually? For how many users is the price given? Are there additional costs? Is support and what type of support is included in the price? Etc.
Extra tip: Look for the holiday season, usually the software vendors are also offering some form of discount or extras during these periods. And if there is no holiday season at the time when you have to purchase, don’t be afraid to ask if you can pay quarterly instead of annually, or ask for a discount- maybe in a return of an annual contract or multiple-year contract, speak your needs and negotiate with the vendor.
Verify the software vendor through online Portals
There are many online portals where you can find a large number of QMS software vendors. These portals are specialized in evaluating various software vendors. During the evaluation every software vendor has to go through an extensive verifying process, and only after it is confirmed that the software vendor is not a fraud, then it will qualify to appear on the Portal’s listing. The Portals are publishing various lists periodically, but most important is that you can also read reviews from their users: a verified user might write a comment with his experience of using the particular software. These comments can give you real insights from similar companies like yours, before publishing any comment, the Portal forces the commenting user to go through a verifying process where they make sure the person is real and the review is valid, the Portal controls everything in order to keep the information real.
Different Portals are offering different comparison features, with the help of these filters you might narrow down the number of potential QMS software vendor candidates by using your specific needs as specific filters.
Some of that I verified and recommend are: G2, Capterra, SourceForge, Software Connect, etc.
Extra tip: Note which filters you have turned on, as they usually automatically show the paid list first. Also, take reviews with a grain of salt, as they can also be bought.
These are my recommendations on how to navigate and find the right match from the sea of the QMS software vendors. I hope they helped, if you have any specific question regarding to the topic that wasn’t mentioned above then I welcome you to find me, I would be glad to help.
