5 Steps to Overcome the Fear of Starting on the MES Journey

Executive Summary

MES evaluations and projects are HARD. If anyone tells you it is easy they are lying or trying to sell you something. Regardless if you are starting from paper-based processes or replacing an older MES system, it is the equivalent of a full house renovation. We are not talking just a paint-job but full down to the bones reno with plumbing, AC, walls, floors, counter tops, furniture, color schemes, material costs, labor costs, contractor costs, and determining where you will live during the construction. A classic renovation might not even sum it up enough. It is really akin to lifting your house off of the foundation and keeping it operational while rebuilding the foundation in hopes of adding more bells and whistles at the same time.

If you jump into it unprepared, without a plan or alignment with your partner and contractors it will most likely drag out longer than you want and be more expensive than you have a budget for. This dissuades buyers from getting the fixer upper homes or dissuades current home owners to upgrade their house to the one of their dreams. 

We’ve seen the same hesitation and fear in prospective MES buyers. They want the “full renovation” from paper (or an out-of-date legacy system) to a nice new digital solution but the idea of going through an MES evaluation is too overwhelming. The idea dies or is kicked down the road to “when the timing will be better.”

This white paper will equip those stuck in the overwhelmed paralyzed state with 5 steps to overcome the fear and lessen the burden of the MES journey. These 5 steps will tell you how you can prepare for a smooth & fast process ahead of time and if your org is not ready to start an evaluation, what you can do now.

#1 Start with the why…always

Step 1 is easy, costs nothing and is simply this: document your whys. We’ve seen folks immediately jump to writing detailed URS docs and specifications that the MES must have before they even consider why they want an MES in the first place. 

‍Don’t skip past the whys to the requirements. They are not the same.  In fact, sometimes the whys will be in direct conflict with what you initially thought your requirements might be.  ‍

How do you start with the whys?

Document a list of answers to prompting questions such as these:

• What outcomes or benefits would you expect to see from a digital system?
• What problems are you hoping an MES solves?
• What business changes are we expecting that we need to take into consideration?
• Quantify the resulting items in the list where possible.

Quantify the resulting items in the list where possible. Examples:

• Number of errors
• Number of CAPAs, deviations, exceptions
• Length of batch review time
• Speed of a batch
• Number of forms

Prioritize the list of whys. You can prioritize by:

• Potential ROI/Value
• Potential Impact/Reach
• Potential Savings

Then inventory who would use or be impacted by an MES and have them add to the list.

This list of whys will form the foundation of your journey. Your detailed requirements should aim to address these whys. When you evaluate vendors, they need to address the whys. They should become a guiding north star. 

#2 Window shop

Even if you aren’t ready to start an MES evaluation there are ways to “window shop”, or look without buying. 
In order from least effort to highest effort here are ways you can window shop MES:

• Pursue the vendor’s thought leadership and public content
• Attend a webinar from the vendor
• Attend a conference (virtual or in-person) where MES vendors present and host booths such as Pharma MES 
• Find a community group where you can converse with current MES users like ISPE or BioPhorum
• Sign up for a product trial, or paid-for proof-of-concept, beta, or pilot program

Why bother window shopping if I don’t have a budget or project yet? Window shopping can help:

• Equip you with ideas of impactful whys to bolster your project request
• Give you an idea of the budget you will need
• Explore different tools available in a lower stress way
• Garner excitement on the potential of an MES to help overcome the fear

#3 Get stakeholders ready

Who is just as important as what in an MES evaluation. To adequately prepare you need to form your team and assess your potential supporters and adversaries. 

• Supporters: Pull your “inventory of who would be impacted by an MES” from step 1 and consider those your potential supporters
• Adversaries: Explore who might be against deploying an MES and seek to understand why to find out who your adversaries might be ahead of time
• Process People: Find out how software evaluations work at your organization including the process for requests, approvals, and how to approach it. 
• Mentors: If possible, find someone in the organization who recently went through a software evaluation similar to MES, potentially an ERP, DCS, SCADA, QMS, DMS, or LMS and pick their brain for tips.

What do you then do with those groups? Casually begin talking about MES with these stakeholders whenever possible and appropriate. Talk about your whys list as much as you can, highlighting not the excitement about a new tool but about solving their pain. No one should be surprised by an MES project request or project kickoff when it finds their way into their inbox and every stakeholder should already be aware of the potential value to the business as a whole and to them as an individual. 

#4  Investigate resourcing 

Yes, resourcing is about budget but it is also so much more than that. Here is what you need to start investigating:

• Find out how & when software budgets and project budgets are pitched, reviewed and approved at your organization
• Find out which projects have been approved in the past and the approximate cost
• Determine who and how many people in your organization would manage an MES
• Determine who and how many people in your organization would configure and deploy an MES
• Determine IT resourcing preferences in your organization (i.e. is your organization one that wants to host your own cloud services or have a vendor host)

All of these add up to either financial cost or headcount resourcing needs. You will want to know what does and does not exist in your organization prior to an MES evaluation. 

#5 Savor acronym requirements soup

Finally, don’t fear the acronym soup of requirements like URS, FRS, RFP, and PRD documents. They are not bad. They are not difficult. They are not new territory. Simply put: your requirements doc serves as a detailed description of how to address the whys.

After seeing hundreds of requirements documents over the years here are our tips:

• Requirements: Steal from product management and agile best practices by using user stories or jobs-to-be-done style formats. We are seeing many pharma companies hiring product owners for their manufacturing software projects.
• Structure: Seek out and leverage best practices in the industry like the MESA Model to help structure the document.
• Length: Do not stress about the length of the document. We've seen a wide range. The best rule of thumb is that they should be as lengthy or concise as needed to make an informed decision.

It doesn't have to be perfect in the first draft. Especially if you are starting this process before you are knee deep in the MES evaluation, you have time to iterate and to get feedback from your stakeholders from step 3. Ultimately you don’t want analysis paralysis to set in because you feel it needs to be perfect right from day one and keep you from moving forward.

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Closing thoughts

While MES buying and evaluation processes are intimidating, there are ways to lessen the burden and gain the confidence to take the next step, or maybe even the first step. If your organization is not ready to begin an evaluation, start with these 5 steps to help move things along and ensure when the time is right, you are ready.

If you are ready to window shop or would like to discuss some of the benefits Apprentice customers have found thanks to our cloud-native platform, we are here and ready to help you begin this journey. Schedule some time with us.