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Document Management System Recommendations

  • 1.  Document Management System Recommendations

    Posted 09-Jul-2020 19:03
    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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  • 2.  RE: Document Management System Recommendations

    Posted 10-Jul-2020 03:57
    Hello Shannon,

    I can not recommend any specifically, there are quite a few out there, and each have pros and cons.  The recommendations I would give is first set out your own specification for the eQMS system or document control system - what you want, need, don't need, optional, etc.  Personally, there are two aspects to obtaining and implementing an electronic system 1) cost and 2) features or application to your needs.  There is a wide range of costs for these systems from free to few thousand dollars.  Though i would recommend using a system first to make sure it is meeting your needs.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: Document Management System Recommendations

    Posted 10-Jul-2020 10:39
    I would add to Richard's recommendation - determine what you document management system is first don't let the tool dictate your process, especially what it can and cannot do. Then look for a tool that mirrors your process with little to no configuration. 

    Additionally, determine what type of documents you want to manage - just SOPs, or SOPs, protocols, forms. Manuals? What about records - are they being considered documents to manage under your system? Domestic only or worldwide users. Are you having your document management system as part of a larger eQMS or only procedures. Look for something that meets both your current needs and future plans. There are some out there that meet needs of small companies, but are grossly inadequate to midsize and larger companies requiring a complete redevelopment of your system to grow the company.

    Stick with established vendors, don't be the test case. And as Richard said - try it out - put it through the ropes - if it doesn't do what you need, or it requires a lot of configuration to do what you need, or to be compliant move on to something else. Also - look at its history of updates/bug fixes and support - if you don't have an IT department to do all the work, you need your vendor to be responsive. The key - as with any QMS - there is no one right answer - they all have pros and cons.

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    David W. Husman, Ph.D., RAC
    Senior Consultant
    PAREXEL Consulting
    Greenville, SC
    USA
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  • 4.  RE: Document Management System Recommendations

    Posted 10-Jul-2020 12:23
    Hi Shannon - I'm currently using greenlight guru for a start-up client. it is cloud based, part 11 compliant and comes pre-validated. it is more costly than other QMS systems but you have to validate those yourself. the reason they can deliver it pre-validated is that you cannot configure it at all. At first this sounded really restrictive to me, but once i learned  how to use it I realized that not being able to change much made it easier to use. i built my procedures around how this system works instead of trying to change the software to match my QMS. The GO module has document management, change control, non-CO routings, training (which needs some but they're promising an upgrade at the end of this year), and design control. The GROW module has CAPA, NCMR, Complaints (and feedback), and audits. You can buy them separately. i think the cost goes up based on number of users. The level of support is excellent. Let me know if you want to talk offline about this in detail.

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    Karen Liu
    San Diego CA
    United States
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  • 5.  RE: Document Management System Recommendations

    Posted 10-Jul-2020 16:43
    Hi Shannon, 
    There are so many things to think about BEFORE you select the system. You need to be sure that you identify the requirements you are looking for  in the DMS, and fully understand the process you are using and the processes you want to use. Only then can you determine the best technology platform to meet your needs.
    We have worked with several companies through the process of requirements gathering, current capabilities assessment, developing improvement ideas, and identifying technology considerations 
    If you would like to discuss this in more detail  off line, please feel free to reach out to me. 


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    Susan Shockey RAC
    Principal Consultant
    Mt Pleasant SC
    United States
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  • 6.  RE: Document Management System Recommendations

    Posted 13-Jul-2020 09:34

    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
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  • 7.  RE: Document Management System Recommendations

    Posted 14-Jul-2020 09:43
    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
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  • 8.  RE: Document Management System Recommendations

    Posted 14-Jul-2020 09:56
    One additional note of the Workflows - most of what vendors show you are the flow of the data / document, not the process. What i mean is they provide very nice flow charts that show the document in the initial state, anyone can change it and as it moves through the 'process' the number of people who can modify the document decreases until no one can modify it. Too many executives think these pretty flow charts define the process since too many quality people create procedures that don't define a process. As all our esteemed colleagues have said - figure out what you need, differentiate that from what you want, document as requirements versus nice to haves. Then engage vendors to see if they can meet all your needs and most of your nice to haves for the costs you are willing to pay.

    Unfortunately, you really cant determine your needs until you spend the time defining the processes you wish to execute and the controls that need to be in place to both facilitate the process and to keep it from going off the rails.

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    David W. Husman, Ph.D., RAC
    Senior Consultant
    PAREXEL Consulting
    Greenville, SC
    USA
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  • 9.  RE: Document Management System Recommendations

    Posted 15-Jul-2020 03:36
    Edited by Julie Omohundro 15-Jul-2020 03:50
    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
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  • 10.  RE: Document Management System Recommendations

    Posted 13-Jul-2020 09:49
    Greetings Shannon,   I was the system owner for a DMS from the mid 1990s to 2010. I endorse many of the comments that you have already received, for your initial decision. While setting your requirements [user requirements] for the system is important, as well as Part 11 compliance, I found that the main challenges were a] doing system upgrades at approximately every 4 year intervals and b] making sure that users would actually 'use the system'. With system upgrades, there is a common belief that legacy documentation will just be ported over unchanged; this is a false assumption. Unless, you or your staff or a closely monitored contractor, visually inspect most of the ported documentation for errors or bugs, you cannot be sure about legacy document preservation post system upgrade.  On the user front, adequate training [usually not supplied by the system's vendor] for the new version of the DMS is vitally important. The system interface will likely change with the upgrade and users will be reluctant to admit that they are puzzled by it. Training needs to be mandatory and endorsed by senior management; it needs to lead the user, on a step-wise and easily understood path, so they feel comfortable and can demonstrate competency [usually best achieved by testing them] in using the new DMS version.I am no longer 'up-to-speed' on all the commercial DMS offerings in the marketplace; however, the Court Square Group [www.courtsquaregroup.com] provides a very flexible approach to DMS solutions for pharma, biotech, and devices, with Part 11 compliance.  They appear to listen and respond well to user situations, regarding DMS solutions, based on feedback from my clients and contacts. This is not an endorsement, just some info that I would want if I were headed back into the DMS marketplace to find a system.

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    S. Albert Edwards FRAPS
    President, eSubmissions University
    Lincolnshire IL
    United States
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  • 11.  RE: Document Management System Recommendations

    Posted 14-Jul-2020 10:53
    Hi everyone - 

    Thank you for the recommendations and advice!  We are a small, but growing, company so it's fun to think longer-term about what we want our processes to be.  Then we will create our user requirements and move forward with looking at different systems.

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    Shannon Strom RAC
    Vice President, Regulatory Affairs and Quality
    Durham NC
    United States
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  • 12.  RE: Document Management System Recommendations

    Posted 15-Jul-2020 11:51
    Shannon,

    Everybody's advice is very sound.  More specifically, we use VEEVA for our DMS system. Like any system it has its drawbacks, but we have been relatively happy. The nice part, is that VEEVA has many modules that can be used by multiple groups i.e. a regulatory management system, quality docs, QMS, Clinical, etc.

    Regards
    Rob

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    Robert Blanks RAC
    VP, Regulatory Affairs and Quality Assurance
    [Ardelyx]
    Auburndale MA
    United States
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