Jennifer makes a great point. Forget about getting any sort of recommendations here generally for stuff like this. Your starting point, if you ask any reputable supplier, is really the "User Requirements" document or a detailed list of must haves, nice-to haves, options and an understanding of what you need to store, how the information come in (format, data sets, etc.) and then a good look at what you plan to do with the information in the system. If this is meant solely as a "file cabinet" (or a file cabinet with some bells and whistles) then one type of system is going to be preferred just based on your requirements. If you have reporting envisioned as a required functionality, then a different type of system will be called for simply based on this decision. If you need something that can grow with your company by addition of modules or additional pieces then you are looking at a different set of options.
Without the user requirements well understood and well defined, I hate to say it but, your project is already derailed. If you simply plow headlong into buying a system (or even setting up appointments for demos) without knowing what you want, need, or desire, your headed for a potentially significant outlay of capital with high potential for not getting what you need, getting lots of things you don't need or want, or having a significant issue with user acceptance and user compliance without lots of time trying to figure out work arounds.
------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States
------------------------------
Original Message:
Sent: 20-Aug-2019 09:49
From: Jennifer Kealy
Subject: QMS sofware and Clinical Study Management software solution for Med Device
I would highly recommend you begin first with an internal needs assessment and get feedback from not only IT, but all types of end users. How many users will you have? What features would you like (ideally)? Do you have PC and Mac users? Can the system allow for different levels of security (including external consultants) and is it fully audit trailed? Do you have specific IT requirements (e.g. do you want a cloud based system)? What is your budget and timeline for implementation? How often do product upgrades come out and how might this impact you? What kinds of reports/dashboards would you like to generate and can you do this easily? Then you can conduct a search, narrow down the field and invite companies to demo/bid. All too often I have seen IT folks make purchasing decisions for clinical/regulatory without understanding their needs. This usually results in low uptake/work-arounds, lost productivity and costly changes.
------------------------------
Jennifer Kealy
Head of Quality, Clinical and Regulatory Affairs
FIND
Genève
Switzerland
Original Message:
Sent: 19-Aug-2019 21:08
From: Anonymous Member
Subject: QMS sofware and Clinical Study Management software solution for Med Device
This message was posted by a user wishing to remain anonymous
How about Trackwise as a QMS? Is that worth investing for QMS when compared with Veeva Vault Quality Docs? As per my experience, Sparta systems' QMS is pretty mature software in the life sciences industry but not sure about pricing aspects. Any thoughts?
Original Message:
Sent: 15-Aug-2019 17:07
From: Anonymous Member
Subject: QMS sofware and Clinical Study Management software solution for Med Device
This message was posted by a user wishing to remain anonymous
Hi all,
We are planning to get implement QMS software solution and software to manage clinical study data for medical device.
Would love to find software that has QMS related modules such as CAPA, Complaint Handling, Audit management, Supplier Management etc and also have option for clinical study data management.
Currently, we are planning to reach out to Master Control and Pilgrims. We would need to have cost effective option for small size company (less than 60 employees).
Any input on how to go about find in out potential solutions and implementation is greatly appreciated.
Thanks you.