We are currently looking for an electronic QMS to manage many of our Quality processes across multiple facilities. I have looked at 15 companies and I'm overwhelmed. Who is using an eQMS software package? Which do you use? How do you like it? Why did you choose that software over another?
Without knowing anything about the types of processes or records to be managed within your eQMS, I would suspect most would provide adequate services. Where we started was identifying what modules were most important and then what features were most important within those modules. Speaking to who will be the super-users can give you this information. Once you know what is important in the eQMS, you can narrow down what system(s) will work best in your environment. What would work for my company may not be best for yours, so I can't say which eQMS I would recommend.
But none of that matters if you don't have a strong administrative team. I have seen over and over companies spend a lot of money to implement top-tier systems only to give up on them because they did not have a successful implementation, or the support to work past the initial implementation phase. We have found that a basic system works if you have a strong team that knows how to fully utilize the system. If you don't have the strong administrative team, having more support from the software provider will be important.
Hello Rachele, My company and I are going through the same thing. We looked at 17 different EQMS software vendors and pared them down by conducting an internal survey of what was needed from the potential users. From that we had five left. We let each vendor demonstrate their software in a one and a half hour meeting (each). Then there were two. We trialed each of the final two for 30 days and made a selection. We were quite thorough because we are a global company and have had global software launched that has not worked out. Hopefully you can pick and choose from what we have done to tailor a method for your situation. Best of luck!
My experience has been several companies have developed spreadsheets, or databases to manage their ISO 9001/13485, AS9011, FDA, etc. compliance requirements. Rarely have these home grown eQMS show alignment with their business expectations (reporting dashboards, current data) or have user/operator manuals i.e. tribal knowledge.
In helping in the selection of a eQMS typically the first concerns has been “What is the budget”. The most importance for the Quality/Business Leaders folks would be to select a eQMS that improves our ISO 9001/13485, AS9011, FDA, etc. customers.
As noted in other posts the proper implementation is key, i.e. the company must have eQMS owners with the Organization Chart starting with management teams responsibilities.
Back to the topic looking for eQMS Software, I have used uniPoint (eQMS) interfaced with the company ERP such as MS Dynamic. I have found uniPoint to have great variety of training materials to help our quality team provide deskside support to our end-users i.e. all listed on our company Organization Chart management, simple, relevant Dashboards KPI's.
Our selection of eQMS, ERP should be great tools and must provide processes and records that our external ISO 9001/13485, AS9011, FDA, auditors/customers are verifying to maintain our certification. I have seen complex process be streamlined, better transparences between eQMS/ERP (true cost of quality), continuous improvements give more internal/external customers satisfaction.