LIMS and ELN Planning – Having the Right Non-Laboratory Team Members

Laboratory and Non-Laboratory Stakeholders

This blog post is part of an on-going series about the LIMS and ELN implementation journey, specifically the Do’s and Don’ts of the implementation planning phase.  Today’s post discusses who should be on your project team from outside the lab.  We’ll take a look at who should be on the team and some of the activities they should complete.

Click here to learn more about the laboratory informatics planning journey

It’s easy to think of your laboratory information management system or your electronic laboratory notebook as a laboratory project.  However, consider the business reasons for the laboratory and include the non-lab stakeholders during your LIMS or ELN planning process.  CSols’ proprietary methodology is based on the SIPOC approach: suppliers, inputs, process, outputs, and customers.  Use SIPOC as a guide to select non-laboratory members for your LIMS or ELN implementation team.  In this case, we will focus on inputs, outputs, and customers.  The following groups of stakeholders should be included when gathering requirements, vetting functionality, and performing user testing.

Inputs

QC Work Requestors

In a QC lab, most lab work comes from manufacturing or production.  Think about what that means for your lab’s workflow.

For example, what system generates sample plans or lists?  If you have an automated ERP or MES, the record of truth for the sample plan might be in one of those systems.  In this case, you will need to plan on developing, customizing, and testing a LIMS interface to these systems and will need to include a system SME and a business SME.  The system SME might be a data base analyst for your ERP who understands the relational database structure.  The business SME is more on the “front end” of the system and understands how laboratory outputs translate to ERP inputs, generally how lab results and billing or CoA generation are interrelated.  Both of these resources are vital to a smoothly operating interface.

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If LIMS is (or will be) the record of truth for sampling information, consider how LIMS will create sampling plans.  Will a laboratory resource or a manufacturing resource manually create the plans in LIMS?  If production drives the sampling plans, include a production SME on your implementation team to ensure related input needs are captured in the requirements stage and meet end users’ needs in the testing phase.

If you want to automate the plan creation, you will need to map out the sampling logic, configure the automation in LIMS, and make sure you test the logic for each product or sample type.  In the case of automated LIMS sample plans, you should include a production quality SME or whoever determines sampling logic and creates quality plans.

R&D Work Requestors

In an R&D or analytical services lab, it is more challenging to create predictable sample plans and automating sample plan logic is less valuable.  However, we still need a way for the lab to find out about in-coming work and R&D often has manual means of tracking this work.  Most LIMS and ELN applications handle incoming, non-sample plan work via a work request system that lab customers use to request analyses and you will need an R&D SME who understands what work is generated and what kinds of analyses are required.  There are countless possible scenarios for accommodating lab work requestors and automating the work request process; the best way to determine what meets your needs is to ensure R&D has input during the needs assessment phase of your project.

Outputs

QC Data Consumers

Now that you’ve completed the lab work and generated results, where do those results go?

In a manufacturing environment, data consumption could be simple and predictable: every final result is reported on a CoA.  Often buyers require a CoA to receive incoming goods and send payment—capturing CoA generation needs could be vital to your bottom line!

To understand these requirements, you can likely leverage the same SMEs you included to understand work requests. To understand how data gets from the lab to the CoA and understand related systems that support CoA generation, include a business SME, a production SME, and a quality SME.   If automatic CoA generation is a goal, you will need to understand specifications logic and document control rules and therefore, a CoA SME or a document control SME should join the team.  It is important to come to a consensus with these data consumers when deciding if you need to build an interface or if LIMS will hold the logic that publishes final data.

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Many manufacturers also use lab data to make process changes and manufacturing decisions.  Finding out exactly who consumes this in-process data can be a challenge, but the time and effort required to understand these data consumers’ needs will be well worth the lower operating costs associated with a robust LIMS implementation.

Once you know who uses the data, include this production SME to understand exactly how they use the lab’s data outputs.  In a batch reactor method, for example, an in-process sample might only need a need a viscosity analysis and those results need to be within a broad range before the next reaction step.  However, if operators want to end the reaction, they may need multiple, precise analyses right away for an end-point.  There are different business drivers for different types of samples and your LIMS will perform best if it is set up to accommodate those differences and publish data to the right people at the right time.

R&D Data Consumers

In an analytical services or R&D environment, the considerations will be much different depending on the specific needs of your lab.  Plan your LIMS or ELN configuration based on who consumes the data and how they need to use it. For example, an engineering group might want pre-configured reports on the same parameters each week. For this scenario, include an engineering SME. However, a development group might wish to access the ELN directly and pull out data in a different manner for each sample. In this situation include an R&D SME.  Depending on the size of your organization and the type of R&D data consumed, you might need to include an R&D technician and an R&D manager as well.

Customers

Remember that LIMS and ELN are enterprise-level systems and—even if other groups undervalue the lab—your laboratory generates value for the business.  Without fail, there is a group who needs to understand that value to do their job.

In CSols’ experience, there are a few groups who need lab data to do their jobs who often get overlooked in the LIMS or ELN planning process.  Depending on the size of your organization and the scope of your project, you should consider the following departments when planning your LIMS or ELN:

  • Accounting—some organizations use laboratory results or laboratory metrics to determine budgets or product costing; accounting often needs laboratory output in an unexpected format
  • Business development—sales teams often like to have data to prove that finished goods perform as promised or to show the laboratories are in compliance with applicable regulations
  • Receiving department—many receiving departments rely on lab data to release in-coming raw materials for use on the plant floor
  • Customer complaints—commonly, customer complaints come from multiple sources, but all of them need individual analyses for in-coming samples and most want to see result trends and related data like how instruments performed on recent calibrations
  • Maintenance—many organizations leverage maintenance resources and tools to manage instrument calibrations, repairs, and maintenance
  • Shipping department—often, shipping is responsible for making sure a complete CoA goes out with the finished goods when they are shipped to the customer
  • Supply chain—supply chain groups often use similar data to the receiving department to negotiate prices and turnaround times for raw materials; this group might also need to access raw material testing records for trending

The final non-lab stakeholder to consider is IT.  As you can imagine, IT team members are vital to your project team.  They are so important, in fact, that IT resources for your LIMS or ELN project get their own post—stay tuned for that blog post to read more about it.

If your organization cannot spare internal resources for needs assessment, vendor selection support, project management, IT guidance, SMEs, or developers, CSols has knowledgeable, experienced resources to fill the gaps and make your project a success.  Our consultants have experience performing every part of a LIMS or ELN project from needs assessment and business analysis through validation and go-live support.  Contact us today to find out how we can help you create the happy laboratory you’ve been dreaming of.


What non-lab stakeholders have you added to your project? Tell us in the comments below.

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