Electronic Laboratory Notebooks – An Essential Tool for CROs

Can you give us an overview of the services Eurofins Lancaster Laboratories provides to the pharmaceutical industry? Who do you work with, and what sets you apart from other service providers?

Eurofins Lancaster Laboratories provides comprehensive laboratory services for the world’s largest pharmaceutical and biopharmaceutical companies offering testing for all stages of the drug development process.

As a member of Eurofins Scientific’s BioPharma Product Testing Group—the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide—we are able support all functional areas of bio/pharmaceutical drug development and manufacturing, from starting materials to finished product testing.

Our harmonization is a true differentiator for us. With a global capacity of more than 1 million square feet, our network of GMP laboratories operates under the same strict quality procedures, LIMS, centralized billing system and online data access portal across 26 locations in 14 countries.

The use of Electronic Lab Notebooks (ELN) is growing in the CRO industry. What is the history behind ELN and what are the key benefits?

The key benefits to using an Electronic Laboratory Notebook (ELN) across an organization relate to harmonization of procedures, efficiency of data entry and access, and the ability to programmatically enforce procedures and business rules. Ideas and discussions regarding the recording of laboratory data in electronic form surfaced in the early 1990s and turned into actual products over the course of that decade. However, it wasn’t until the new century that this idea really gained sufficient traction to become an accepted part of a commercial laboratory’s IT arsenal. ELN projects became commonplace in Big Pharma R&D during the 2000s, but are still the exception rather than the rule among Contract Research Organizations (CRO), especially in the analytical testing space.

Has the use of ELNs become a “must have” for your company? Why are ELNs so important when interacting with regulatory agencies? How does the use of ELNs help you to solve challenges that your clients bring to you? Specifically, how critical are ELNs when talking about topics such as data integrity, audit trails and overall operational flexibility?

ELN has indeed become a must-have within Eurofins BioPharma Product Testing. We are in the process of rolling out our ELN solution to all labs world-wide as it is a key piece of our company-wide data integrity initiative. It allows us to keep a very extensive audit trail of entries and changes, and we have built customizations that present this information in useful and noticeable ways in order to make review of the data more efficient and effective. These initiatives have already earned us praise from a number of auditors (and envy from customers who have the same ELN software but without the Eurofins customizations). It is a clear demonstration of Eurofins’ commitment to the comprehensive integrity of our lab operations and data collection. Our goal is not to be purely reactive to audit findings, but rather to find and fix issues before they become problems for us or our customers.

What is Eurofins’ approach to ELN and how is it different from other contract service providers?

Our approach to ELN mirrors Eurofins’ long tradition of developing and/or customizing business-critical software in-house. We chose to adopt Biovia Workbook, the leading ELN of the pharmaceutical industry. This is a broadly-featured, yet vastly customizable, software system designed out-of-the-box for compatibility with regulated workflows like ours. We have added a large number of in-house customizations to adapt the software more closely to our business and to enhance and promote harmonization of testing practices, standardization of documentation practices, and overall efficiency of operations. We are using ELN as a mechanism, not to just enhance existing practices at our many laboratory sites, but also to harmonize those practices as part of a common lab testing platform.

What truly sets Eurofins apart from other CROs is the scope and breadth of our ELN deployment. We have hundreds of users spanning all areas of testing, including chemistry, biology, bio/ chemistry, microbiology, raw materials testing, finished product testing, facilities testing, as well as medical device testing and sample administration and logistics. We are deeply committed to ELN as an integral part of our software infrastructure and continuously seek to improve it and expand its capabilities.

If a company is looking to partner with a CRO and is interested in their ELN capabilities, what are some key ELN features to have in place? What types of questions should a company ask a prospective CRO about their ELN capabilities?

When a customer is evaluating potential CRO partners with respect to their ELN capabilities, a key area to probe is data integrity. Is the CRO actively engaged in protecting their data and constantly looking for ways to improve their practices? Is the Quality Assurance department actively engaged in this process? Is the CRO using electronic notebooks that enforce standardization of documentation practices, via things like context-specific access to entry fields, and per-field programmatic business rules, or are they just using freeform notebooks that happen to be electronic? The latter “it’s good enough” practice is no longer good enough. How does the CRO perform non-GMP work like method development? Do they take shortcuts or do they document with the same rigor as with their regular testing? At Eurofins, we perform this type of work under GMP, even though we technically don’t have to, because doing so demonstrates an attitude of care and integrity both inside the company and outwards, to our customers.

As the pharmaceutical industry becomes more global in nature and interconnected, is Eurofins meeting these challenges by offering a global harmonization of services and benefits across its locations? Can you talk specifically about your worldwide ELN network and future plans for expansion?

Eurofins has been using ELN across our US BioPharma Product Testing laboratories for several years now, and we have developed a suite of ELN notebook templates and capabilities that cover broad swaths of testing in the areas of Raw Materials, Finished Products, Microbiology, and Bio/Chemistry. We are working on bringing ELNbased electronic batch records to our cell culture and banking operations, which will be an industry first. We have also built comprehensive and flexible ELN templates to support performing generic procedure execution to GMP levels of documentation quality. These templates are then being rolled-out to other Eurofins sites around the world to meet our standards for harmonization. Our goal is to provide every Eurofins BioPharma Product Testing site with ELN capabilities to support harmonized testing practices for the commonly-available services that they offer, as well as support for the unique niche testing services that many of our laboratories provide.

With more than 20 years of experience in the fields of scientific data handling and laboratory software development, Dr. Jegla oversees the maintenance, customization, training and dissemination of Eurofins’ Electronic Laboratory Notebook (ELN) software across Eurofins Lancaster Laboratories and Eurofins BioPharma Product Testing group. He also serves as a member of the team responsible for overseeing Eurofins’ worldwide data integrity and data access initiatives. Dr. Jegla earned a doctorate in Analytical Chemistry from the University of Idaho and has held positions with leading scientific and software companies such as BP, Bayer, and Biovia.

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