Hello,
First please clarify to which RIM you are referring, Regulatory Information Management or Regulatory Intelligence Management. They have the same acronym. Neither is in the RAPS
International Regulatory Acronyms & Definitions second edition.
My understanding is that Regulatory Information Management is how you file, sort, and link electronic copies of your historic global regulatory filings and subsequent submissions (like supplements and annual reports) whereas Regulatory Intelligence Management is how you file, sort, and update electronic copies of your regulatory requirements, standards, and guidances.
Each system has their own unique challenges and potential land mines. The main problem I have seen is the legacy systems that a few individuals have been working with. They know how to find information on these systems though even though they are totally counter-intuitive to a newcomer and sometimes incorrect, incomplete, and/or out of date but they resist change because they see no reason to have to learn a new system.
I would like to hear what others have experienced with these systems. Would anyone want to start new threads on each RIM?
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John Minier, RAC
Director
Minier Medical Device Consulting
john@johnminier.comHighland Mills NY
United States
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Original Message:
Sent: 07-Feb-2017 10:51
From: Anonymous Member
Subject: RIM: Wish list and pain points
This message was posted by a user wishing to remain anonymous
Hello everyone,
One of my major goals this year is to launch an improved RIM system in my (very small, n = 35) company. Part of product launch is investigating the pain points for users, and a wish list for new system.
Since I have such a small sample to pull from, I hope to get some input from this community.
- What are your pain points in your current RIM system (or one that you have experienced in the past)?
- What are your wishes for a new system, assuming that traditional barriers are removed (in other words, dream big)?
- Finally: If you have done this transition previously, do you have any lessons learned to share?
Thank you for your time and input!