Hi Ginger. There actually is a "Like" button, only it's called "Recommend." It's not clear to me that it serves any purpose, but I use it from time to time anyway,. Including for a good number of your posts, I'm quite sure!
I guess I've been here too long. What I was thinking while reading all the comments is that I've read this discussion in the Forum countless times, sometimes regarding a DMS, even. Other times it was about some other kind of tool. Or a consultant. Or some other type of supplier.
The comments always come down to one thing: Define user requirements. And the comments are always on target, because this is always true, no matter what you are in search of, as it is equally true for product development.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 14-Jul-2020 09:42
From: Ginger Glaser
Subject: Document Management System Recommendations
Oh Victor - you make me really wish for a "like" button on this forum!
What he said - 100% agree. Look up the history of IT implementations gone bad and you will see the biggest common root cause was not fully defining the requirements - including for all the various end users. SPend time on this and you will be rewarded.
Additionally, over the years I have had various leaders/executives say "the new processes/workflows can be made our procedures and will be more efficient and effective than our current ones." This never, ever works. First, because those workflows are never as "best practice" as they say, and second because they almost always don't address key things in YOUR business. No two businesses are the same - think about - what works for a disposables business may not work for a capital equipment business etc.
I hope you take Victor's advice and a back someday to tell us how successful it was.
Ginger
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Ginger Glaser RAC
Chief Technology Officer
MN
Original Message:
Sent: 13-Jul-2020 09:33
From: Victor Mencarelli
Subject: Document Management System Recommendations
Warning! Long post below!
Hi Shannon.
Let me put this simply - the fastest way for a project like this to derail is to allow someone else to tell you how to do it. Meaning - if you go out looking at systems without first knowing what you "must have", what would be "nice to have", what you are "able to negotiate about" and finally what you "don't need/want" all you are doing is wasting your time.
I have been involved with more than a few automation projects in my career and those that went well had one thing in common - they all had a robust user requirements document to start out with. Without this document you are shooting while blindfolded. You don't know what you need or what you don't need other than typically very high level information which is really not helpful in general. You need to understand process, plan, growth, needs, desires, user reluctance issues (if the system can't do _____ I won't use it because that is what I use/need) etc. So I strongly recommend knowing this before you start the process of looking at things.
To the thought I writing your processes to match the system you choose - I would disagree. Your company has created a system that you use currently. They have done that for a reason. Now, if you find that the computer system you choose to move forward with actually improves your company's system, GREAT! More than likely though you will need to spend significant political capital to get all of the necessary groups/departments/managers/personalities (define it however specifically you desire!) to get them all on-board with whatever you choose - especially if this is going to change their process or potentially impact their authorities in any manner. What you could consider in my mind is doing some checking online first (Google is your friend in this case!) to see what some of these systems can and can't do. If I have my requirements documented then I have a pretty easy time starting up with an understanding of what systems check off which pieces of the requirements. Also, keep in mind that it is extremely likely (almost a foregone conclusion actually!) that you are going to find a system that does everything you want/desire/nice-to-have and has nothing that you don't need or want. So go into the discussions with that mindset to begin with and ensure your entire project team understands that critical piece of information as well - otherwise you risk having internal strife/turmoil because different groups want different pieces of the puzzle evaluated differently.
Once you have all of this together, and you have done some basic due diligence, start contacting some of the vendors of the systems. Vendors that are confident in their system and the system's ability to meet your requirements/goals will be very happy to talk with you and even often provide a period of testing where you and your team can interact with not only the system but also with the vendor's support staff. This is crucial because even the best IT team in the industry is still never going to understand a system better than the support staff who were involved with the coders! If you are outsourcing your IT, then it is even more important to work with the vendor and their support staff because it is likely that they will be your point of contact for IT issues with the system. To that point I would also ensure that whatever system you choose, you have in writing from the vendor what they will and will not be able to assist with and what the charges might be (is it retainer, pay-as-you-go, or some sort of hybrid). Also ensure that you understand what the vendor expects from whomever is managing the system as the administrator in your organization or this can create multiple issues!
Once you have narrowed it down to a select few, bring the vendor on-site to meet with all of the parties involved. Make sure everyone is on-board with whichever vendor you choose. Also, ensure that you have buy-in from executive leadership because when things go sideways (and they almost always do at some point!) you will need the executives in the company to help realign the situation. Someone invariably will say that they can't use the system because _________ and you can fill that in with any excuse in the book - I have literally heard almost all of them! Usually the problem is simple in that the employee(s) involved feels like they are being pushed out of a job for automation which I have found is almost never the case. Once the employee realizes how much work, energy, effort, headache, etc. that the system will save them, they will become the biggest advocates for using the system! It is just a matter of getting everyone on the same page. But again, that goes back to earlier when I said you need to make sure that everyone is aligned on what your list of priorities and needs actually are. Don't try to do this in a vacuum or bubble because that is the most certain path to failure, animosity and missed opportunity. If everyone understands what the plan is, what the ground rules are, what the requirements look like (and their relative importance!) and how the system will be used and can help them in the future state - you are in a much better place already!
Please feel free to reach out if you would like to discuss this further!
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Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
Original Message:
Sent: 09-Jul-2020 19:03
From: Shannon Strom
Subject: Document Management System Recommendations
Hi everyone - I'm looking into different document management systems and would love your recommendations and feedback on different systems. Ideally, our future DMS will be cloud-based, Part 11 compliant, would not need internal superuser support, and is economical. Which systems have you used before? Pros and cons of each system?
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Shannon Strom, PhD, RAC
Vice President, Regulatory Affairs and Quality
Durham NC
United States
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