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IDMP Compliance Storm is Brewing for Pharma in the EU

by Michael Shanler  |  January 25, 2016  |  Comments Off on IDMP Compliance Storm is Brewing for Pharma in the EU

As we dig out in the US from the Winter Storm “Jonas” (aka #Snowmaggedon, #Snowpocalpyse #Blizzgazzhi, #Blizzard2016) and deal with snarled traffic, delayed flights and rescheduled meetings…it reminds me that the  IDMP compliance “storm” will arrive in similar fashion.  It will be forceful, messy, confusing.  Folks need to be prepared with what is predicted on the horizon.

Over the last 18 months, we’ve taken a ‘flurry’  of calls (pun intended) related to how IDMP compliance can be achieved in the short term and maintained long term.  While the date for initial compliance has been legislated, the “when” (timing of the compliance requirements and waves go into effect) isn’t so clear.  Also,  the “what”  compliance looks like, is a bit fuzzy.

This is akin to living on that ever-shifting rain-snow line in New England.  i.e.) TV Weather anchor:  ” Residents should expected snow totals are between 2″ and 24″ depending on different parameters from conflicting European and US weather models. ” Ugh.   Really? WTH!

We ask ourselves:  “Do I need shovels or hire a plow?  Do we shop for extra milk and bread?  Will my kids be home with me on Monday?”

The “how” to be compliant in the short term  is the part that CIOs needs to make sure get addressed ASAP.  While, we have a short reprieve from the storm and some time before the next weather front, it is not the time to get comfortable.  In the end most organizations will be pressed during the mad-rush for compliance.  Many will resort to leveraging bodies and spreadsheets.  Others will rush to customize existing RIMS systems. A few will build or adapt new RIMS systems.  We also see growing interest in leveraging MDM as a long term solution, but this requires a completely different approach and level of investment.  For our insights into IDMP, see here: Delayed and Confusing IDMP Compliance Requirements Demand Life Science CIOs Pursue a Two-Part Strategy 21 January 2016 G00289618.

Here is what we do know about what is on the IDMP front:  The EU will require companies selling into the market to maintain IDMP compliance with a phase-in over the next few years.    You should expect multiple IDMP precipitation fronts but IDMP precipitation types are still TBD.   The technical committee working with ISO standards has taken a lot longer to piece together their recommendations, but they are diligently working….so more information will soon come.  Periodically check those IDMP weather reports to make sure your planning is consistent with the challenges and business goals. Share this information with your internal functional groups – manufacturing, compliance, regulatory, quality, safety, etc.  In the end we see compliance with both a short-term and long-term IT lens.  You’ll need to pick your strategic approach for shoveling out, then pick your tools for executing with agility and through some uncertainty.  Happy Shoveling.

Additional Resources

Category: compliance  manufacturing  pharma  pharmaceutical  rd  regulatory  supply-chain  

Tags: idmp  pharma  pharmaceutical-2  quality  regulatory  

Michael Shanler
Research VP
5 years at Gartner

Michael Shanler covers life science R&D technologies. Read Full Bio




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