D
DRAMMAN
Is anyone using a cloud service to manage their QMS?
D
DRAMMAN
Re: Anyone using a cloud based QMS software ?
Yes. Also if anyone is using the QMS specific cloud applications such as Verse Solution, Master Control, etc. I am interested in hearing about your experiences. I am not a SW seller but would be a user.
Yes. Also if anyone is using the QMS specific cloud applications such as Verse Solution, Master Control, etc. I am interested in hearing about your experiences. I am not a SW seller but would be a user.
I have one client in Texas - Condumex that uses Google for every part of the entire system (Payroll, warehouse, transportation, Quality Management System and Supplier) amount some. They are into distribution and being doing it for 5 years plus.
The help is very good and it is free up to certain amount of users.
(yes, it includes Excel, word, power point and Access)
pbojsen
Involved In Discussions
My company is using a few cloud-based systems for QMS management, depending upon the subsystem: one software for complaints, another for training, etc. So far we have four cloud-based systems.
I will caution you. If you're in the medical device business and are complying with ISO 13485, you will be required to validate the QMS software before deployment. If you purchase the software and install it in-house, you pay up front a bunch of money and validate. If you get a cloud-based subscription, these companies are pushing out new features and fixes every quarter, which entails various degrees of re-validation before they deploy EVERY SINGLE TIME, and YOU HAVE TO TAKE their updates, either right away or eventually. You will need someone on-staff that knows how to validate software, or forever be finding someone to outsource it to. You should also have software validation SOPs in place as you have to validate your business process, and the vendor absolutely cannot do this for your. Ask your potential provider about that. Since I do the software validation at my company, it's a special hell for me as it takes up about a quarter of my year doing these from my "normal" job.
You either pay up front, or pay at the end. They're going to get you either way, and your IT department will have zero control over it and will take no responsibility if/when things go sideways.
Also, get the validation package from them if you can. At least they can provide you with functional testing and if you're lucky, some form of user testing. Otherwise, you have to fool around with the software and figure out how it works before you write those 65 page test scripts. That's not an exaggeration.
I will caution you. If you're in the medical device business and are complying with ISO 13485, you will be required to validate the QMS software before deployment. If you purchase the software and install it in-house, you pay up front a bunch of money and validate. If you get a cloud-based subscription, these companies are pushing out new features and fixes every quarter, which entails various degrees of re-validation before they deploy EVERY SINGLE TIME, and YOU HAVE TO TAKE their updates, either right away or eventually. You will need someone on-staff that knows how to validate software, or forever be finding someone to outsource it to. You should also have software validation SOPs in place as you have to validate your business process, and the vendor absolutely cannot do this for your. Ask your potential provider about that. Since I do the software validation at my company, it's a special hell for me as it takes up about a quarter of my year doing these from my "normal" job.
You either pay up front, or pay at the end. They're going to get you either way, and your IT department will have zero control over it and will take no responsibility if/when things go sideways.
Also, get the validation package from them if you can. At least they can provide you with functional testing and if you're lucky, some form of user testing. Otherwise, you have to fool around with the software and figure out how it works before you write those 65 page test scripts. That's not an exaggeration.
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DRAMMAN
Thanks. We are not a medical related company. I have been looking at some of the cloud based application. Some look very good. There is a very good free corrective action system called Traqpath. We have also been using Jira to build corrective action and issue tracking processes.
That is very true pbojsen
Bromley_Voxel
Registered
We are in the process of implementation and use a combination of two cloud based systems. We have a cloud based ERP system as well as an internally developed Wiki. The Wiki contains many of our forms, logs, quality manual, procedure, work instructions, etc. The benefit of a Wiki is the built in revision control, the ability for user access control, and the free form nature of being able to create whatever form, log, or document that you require.
Slightly off topic... Thank you for that explanation @pbojsen. We are implementing our QMS on a Wiki based system (essentially an internal intranet) and developing forms within it. If I understand correctly, we will need to have a software validation procedure to ensure that our forms and resulting logs are being executed as we anticipate. I assume the procedure would have to detail all of the possible uses/combinations of use of the software and that it performs as expected in all cases correct?
I will certainly make a best faith effort to ensure that the software is well validated prior to implementation. However, I struggle to see how a CB would audit a software validation procedure other than noting that it exists. Without a solid understanding of the software and scenarios that could be encountered this would be a difficult thing to review.
Slightly off topic... Thank you for that explanation @pbojsen. We are implementing our QMS on a Wiki based system (essentially an internal intranet) and developing forms within it. If I understand correctly, we will need to have a software validation procedure to ensure that our forms and resulting logs are being executed as we anticipate. I assume the procedure would have to detail all of the possible uses/combinations of use of the software and that it performs as expected in all cases correct?
I will certainly make a best faith effort to ensure that the software is well validated prior to implementation. However, I struggle to see how a CB would audit a software validation procedure other than noting that it exists. Without a solid understanding of the software and scenarios that could be encountered this would be a difficult thing to review.
pbojsen
Involved In Discussions
You should validate according first to your business needs. Then go for regulatory reasons. We're regularly have auditors ask for our sw validation documents for ERP and Training, at least. If you have something that is systematized, looks in order, and gives the impression that you know what you're doing then they likely won't do a deep dive. Most auditors don't have time for it. Templates make any documentation job go faster and with more consistency. Good luck
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