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Implementing Electronic Lab Notebooks
Building the foundation

This is the second article in a series on best practices in implementing an Electronic Laboratory Notebook (ELN). The previous article1 identified five core areas which, when used to guide the management of an ELN implementation, will optimize return on investment (ROI) and ensure a successful ELN deployment. This article discusses the first core area: Establishing a Solid Foundation.

Introduction
Before installing and deploying an ELN within the research organization, you need to establish a solid foundation upon which to install and grow the ELN. As an enterprise software package, the ELN not only impacts the daily routine of bench scientists; it also changes the way supervisors and support organizations act on and interact with ELN documents and the information stored in documented experiments.

Establishing a firm foundation for an ELN implementation begins with asking fundamental questions about why your organization is implementing an ELN for R&D and what benefits you expect to achieve. The questions can seem trivial on the surface, but as you work through the answers, you will see that exploring them requires a deep dive into your fundamental work processes.

The Ten Questions
In the process of planning the ELN installation, the discussions amongst stakeholders and key users should include the following ten questions. The ensuing discussion and ultimate answers will generate information and insight into the work processes that need to be addressed when working in the ELN.

The information will also define aspects of the ELN such as how data is produced and documented, what users do with experiment data, how data is used by other groups and how it supports daily activities. Additionally, the analysis examines how experiments and data are shared amongst groups, where handoffs need to be managed and what integrations with other systems can facilitate document creation.

Who will use the system?
Although the first response may be, “The Scientists,” the analysis should identify which scientists. The various scientific disciplines, e.g., discovery biologists, process chemists and formulators, etc., have different needs when documenting their experimental work. Understanding what scientists are using the system will guide how the ELN is configured to meet discipline-specific scientific workflows.

In addition to scientists, other groups such as legal, quality, compliance, etc. also access experiments and data in the ELN. The needs of these groups are vastly different from the needs of the scientists who create the experiments. For the ELN deployment to be successful within the enterprise, the needs of these groups also need to be identified and fulfilled.

What scientific workflows will be documented in the ELN?
Workflows differ depending upon the scientific disciplines using them, and each workflow puts different demands on the ELN deployment. After identifying the research groups who will use the ELN, you will need to document and analyze their daily routines. This analysis should highlight items such as:

  • Type of data recorded, e.g., text, tabular, images, external files, etc.
  • Amount of data
  • Data sources
  • Methods used for data analysis
  • Format of results
  • Reporting requirements
  • Extent of interdisciplinary collaboration

Workflow analysis will drive the number and configuration of templates used to document experiments. Having a template that matches the work and data flow of the scientist will make the system easier to use which will result in faster adoption.

What are the impacts of workflows on other groups?
Analyzing scientific and document review workflows highlights the various actors who either impact or are impacted by these workflows. Scientific workflow analysis points out collaborative interactions between groups, i.e., process chemists and analysts who share information when documenting experiments. Document review analysis reveals the needs of quality groups, legal and other non-scientific groups who access ELN documents.

Understanding these dynamics and including them in your planning will help build a solid foundation for your ELN deployment.

What integration will be needed with other systems?
An advantage of an electronic environment is its ability to support integration among different systems. For example, direct connectivity with hardware such as balances allows for automatic recording of values, eliminating transcription errors. Integration with Laboratory Information Management Systems (LIMS), Scientific Data Management Systems (SDMS) and other Document Management systems supports direct sharing of data, which can eliminate time-consuming cutting and pasting into paper notebooks.

A survey of the other software commonly used in the research environment will highlight the systems where direct integration can save time and reduce data recording errors.

Will the system be deployed locally or globally?
Knowing where researchers work when accessing the system and the infrastructure available to support the transport of data are two key items that need to be addressed prior to ELN installation and deployment. Insufficient bandwidth between sites can result in frustratingly slow performance, diminishing system use and reducing the data available for mining and analysis.

Deployment to multiple sites may also require analysis of security policies regulating access to the stored data. Although the ultimate goal for an ELN deployment is total access by all users to all data, local requirements may require limiting access to some data stored within the notebook to specific groups.

Will the system be deployed in a validated (GxP) environment?
The deployment of an ELN may extend to groups working in validated environments. If any of these groups have been identified as potential users of the ELN, then validation plans and scripts need to be developed and implemented according regulatory agency requirements and the company’s policies.

How will documentation practices be harmonized?
When working with paper notebooks, it is very easy for different users or groups who perform the same or similar procedures to develop divergent ways of documenting the data collected during experiments. For example, groups operating bioreactors have developed both Excel and Access applications for recording data. In an ELN environment, harmonizing procedures in both experiment execution and data recording minimizes costs and standardizes procedures for searching and mining data.

Prior to deploying the ELN to different groups doing similar work, it is a good idea to examine your existing SOPs, execution practices and data recording procedures and harmonize them to a single standard.

How will experimental data be used?
The advantage of an ELN compared to a paper notebook is the ease with which data can be shared and/or mined. ELN documents can be viewed by anyone with access to the system regardless of their physical location. Data can be extracted into third-party applications for advanced data analysis and presentation. Understanding how the data will be used will guide template design and ultimately how the data is recorded and indexed in the database.

Who will fulfill ELN-specific roles?
An ELN implementation creates new roles for people involved in installing and maintaining the system. These positions include template editors to create document templates, system administrators to create user accounts and notebook folders and super users to provide local support. This is in addition to more traditional roles for network applications such as network, server and database administrators.

What is the governance model for managing the ELN?
Another aspect in establishing the foundation is setting governance and security expectations. Organizations should identify infrastructure, system and scientific workflow administrators and determine a governance model that specifies how the organization will manage change. Who can make changes? What can be changed? When can these changes be made? Where will the changes be made, tested and documented? Such decisions are particularly critical in validated environments, though governance is essential for any organization that expects the ELN to support intellectual property claims or regulatory filings.

Summary
The ten questions listed in this article will guide project managers and stakeholders through an important analysis process which identifies the needs and functionality required in the ELN deployment. Understanding users and their needs creates a solid foundation upon which to build, configure and deploy an ELN for use by multiple groups within the enterprise.

References
1. Lass, Bennett D., “Implementing Electronic Lab Notebook: How do you Define and Manage Success?” Scientific Computing, June 2, 2011. http://www.scientificcomputing.com/articles-IN-Implementing-Electronic-Lab-Notebooks-060211.aspx.

Bennett Lass is the Director of ELN Services at Accelrys Inc. He may be reached at editor@ScientificComputing.com.

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