Ever think about how much work it is to deploy an Electronic Laboratory Notebook (ELN)?
Seems like an overwhelming task.
For many organizations it is.
But is doesn't have to be...
Existing processes have often been developed in a piece-meal fashion over many years. Most often in response to an immediate need and hence developed with deadline pressure that may have resulted in some corner cutting. Even when existing workflows were well-planned and optimized, business requirements are likely to have changed due to reorganization, changes in regulation, or other shifts in priority. Having managed and observed many ELN deployments, I’ve found that regardless of the current state of your laboratory record keeping methodology, keeping a few simple truths in mind will help make your transition to an electronic laboratory notebook a success.
1) Nobody likes change. Some are prepared for it, some can begrudgingly accept it, others will actively fight it. For most, the status quo is a comfortable, safe place to operate. So change as little as possible. For example, signature and witnessing procedures should not be modified during the conversion to electronic records.
2) The benefits are real. Not just to the organization, individuals find that by using templates and standardized text, they save a lot of time. I’ve found that most folks don’t appreciate this until they have experienced it for a while. Then they love it! And when they actually see the data coming in from labs around the world in real time, there’s no going back.
3) Prepare well. Understand the existing workflows and procedures. Learn why tasks are done a certain way. Know the in-house resources and capabilities. Most deployment problems I’ve encountered have been due to improper planning. End-user client platform requirements is often a hang-up. Some .dll or browser configuration hasn’t been communicated properly for example. Placing requirements on a process or deployment that an organization cannot meet, will cause nothing but trouble.
4) Stay focused. Do not be distracted by every need or objection that arises. Rather, anticipate that there will be objections and be flexible about addressing them. The most common objection I’ve seen is that management will use the ELN as a performance metric. Explaining the reporting capabilities and giving users input to the contents of the report can alleviate this concern.
5) Train, Train, Train. Think of the entire process as a training exercise. Train users at the beginning by informing them about what’s happening. During requirements gathering, let the stakeholders know what to expect. Remember, users and managers will be learning throughout the project.
6) Follow-up. Pretty soon after rollout, contact some key stakeholders to see how the new system is working. Catching any unforeseen issues early, and addressing them promptly will ensure a long lasting solution. And remember, key stakeholders are not just power users or managers, the harshest critic can often become your best ally if their issues are handled well.
Let’s take a look at each of these a little more.
– People are creatures of habit. Every day we go about our activities in a more-or-less routine way. For example, very little critical analysis is given to our commute to work! The same is true for most work tasks; they are simply repeated from day to day and week to week. Folks tend to become familiar with their work tasks and are reticent to change them - and an ELN is a BIG change! So, make it simple for the users; change the environment, not the tasks! Don’t try to sell the features that your vendor sold you on. Rather, use those features to make life simple by replicating existing tasks. Your vendor will gladly help you do this!
Utilize familiar form layouts. Don’t rename fields. Keep the familiar tasks familiar. Keep the order of tasks the same, even if your vendor claims that efficiencies can be found by reordering. The truth is that electronic documents and workflows allow for reordering and reoptimizations far easier than paper systems. Your power users will even be asking for training on some of those “advanced” features to help these optimizations. Soon your users will realize that they are performing precisely the same workflow, only in a new environment. Like driving a new car to work!
–The benefits of an ELN can be divided into two categories: organizational and individual. Many of the features of an ELN will provide benefits in both categories. Try not to mix them up when addressing your audience. While most end-users will agree that organizational benefits are good, they are more concerned with the effect on their day-to-day jobs. The same goes for senior managers. They agree that improvements to individual contributor work are positive, but it is the aggregate efficiency that an ELN provides the core business operation that they find most beneficial. Focusing on the benefits for the specific audience will keep them actively engaged.
The individual benefits of an ELN to a researcher or technician can be profound. A review of medicinal chemists’ use of an ELN has shown that they spend up to 25% more time in the lab performing experiments after starting to use an ELN to plan and record those experiments. More time performing experiments yields more results. They further found that not only is less time spent planning, but that planning time is far more efficient. Using templates and having access to the entire organisations experimental library, these scientists estimated that their experimental design was improved two-fold.
The organizational benefits of an ELN depends primarily on the nature of the business being documented. Research and Discovery groups will find that Intellectual Property protection is much simpler. No more paper notebooks to store and catalogue. Documented research is at a librarian’s fingertips. Legible and uniform data and interpretations make a review process much quicker. Chief legal counsels at major pharmaceutical have attested to this fact.
Most industries have some sort of regulation and electronic record keeping makes compliance much more efficient. If integrated with an existing document management systems, your laboratory records now have the same back-up, recoverability and organization that other business critical document have.
For pharmaceutical development and production business units, compliance with 21 CFR Part 11 is a critical fact of life. ELNs allow these organisations to collect the correct data, in an accurate and precise fashion; save it in a recoverable, reportable, and auditable way, and archive it in a cost-effective location. Many GLP sites have reimplemented, and in some cases redesigned their process validation and verification procedures with an ELN.
So, you can deploy new methods to your entire organization. Ensure that your best practices and safety requirements are available to all your scientists and technicians. Your safety office will sure be pleased! The common form and location of your technical and scientific data makes collaboration a breeze. Sharing notation and units, eliminates many points of confusion. Quick access to raw data makes verification and reanalysis simple.
– When approaching an ELN deployment project, understand the requirements as they pertain to all aspects of the project. Hardware, software, business reporting and legal compliance are some common considerations. A simple use case example might be of an electron micrograph. A picture of an inorganic catalyst, annotated by a scientist can easily be incorporated into a paper notebook. However, in electronic form, it will require a lot more data storage than a page of text. To be totally electronic, it will also require electronic software that allows the image to be annotated. If that’s too much integration effort, perhaps the solution is as simple as scanning the hand-annotated micrograph and uploading. Leveraging existing capabilities and resources of an organization makes the job much easier. If there is a scanner already in use, don’t change that right away.
When documenting existing tasks and workflows, seek to understand the reasoning behind them. Most often there is a good rational for a process. Finding that reason is critical to making your project decisions wisely. Other times, there is no good reason, it’s simply “the way it’s always been done.” Then you can work out a superior solution that will endear you to the user!
For example, we once came across a group that would photocopy a standard chromatograph as part of a written protocol. Turns out that this task was entered into the protocol at a time when multiple copies were required for the library. The library no longer needed these duplicates, and by scanning directly to a workstation, the chromatograph was electronically documented (with the operator’s hand-written notes) suitable for reporting and archiving.
– In every project, there are moments when it seems like there are too many obstacles to be cleared. By having a system that addresses each issue in a positive and satisfactory manner your project will actually benefit from these “objections”. It will be a stronger and more relevant solution! Once, researchers found that while collecting seedling height data in the field (literally) it was inconvenient to type in numerical data from a keyboard, so a stylus driven tool was embedded. Be sure to have recruited motivated domain experts that you can call on when needed. Nothing will build confidence in you (and your solution) more than a well-met challenge.
In my experience, you will need IT resources (Networking, Databases, and Security) to deal with the infrastructure. Issues such as network latency, data transmission speeds and administration of permissions, require the capability and willingness of IT to assist. Senior scientists who understand the subject matter and are willing to support the project, will provide you with both the information and the credibility to succeed.
This was key to a deployment where process chemists and research chemists were sharing a Notebook form for a reaction. The research chemists required "access" and "edit" to all amount fields. The process chemists informed the team that these field should be locked for use in production. Role-base permissions were implemented on the form and the issue was resolved. Remember, creating a useful and efficient tool for your scientists and technicians is the goal after all. Keep it in mind at all times, and ask for help when needed.
– Structured training is a great way to help people both learn and become convinced that they have learned something. You should think “Talk-Show-Do”: Explain the task, demonstrate the solution, and provide user exercises.
Make the training sessions short and applicable to daily tasks. No more than ½ day sessions with at least 2 breaks. Often people cannot commit to longer, chemists will need to attend to their reactions and cannot make a full day session. Grouping folks by discipline keeps topics relevant to the users. Biologists will yawn loudly at how easy it is to calculate an actual reaction yield. Use the test cases and user examples to continue the familiarity you’ve built. Too much theory about how and why things are done will grow old fast.
Remember that learning is an ongoing process. By the time you get to roll-out training, it should be an in-depth review of what folks have already learned during the process.
– In the end, everyone likes to voice an opinion. Your new ELN users will need this opportunity. Schedule sessions between 1 and 2 months after roll-out. This timeframe allows users to develop enough experience to make cogent judgements. Enough time to have trends begin to develop. But not too much time for frustration or awkward workarounds to have taken hold. These follow-up sessions will allow you to see the benefits of your work, hear the complaints and make necessary adjustments. Best of all perhaps, you will be better prepared for the soon to arrive Version 2!!
If you hold these truths close when deploying an ELN, no matter the scale, your project will be a success. Keeping things simple and a positive attitude are essential. Having seen both successful and unsuccessful ELN deployments, I can assure you that these few simple bullets do make all the difference.
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