Electronic Lab Notebook provides critical element to data integrity initiatives and harmonization
by John D. Jegla, Manager, Pharma ELN
Harmonization is a true differentiator for us. As a member of Eurofins BioPharma Product Testing (EBPT)— the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide— Eurofins Lancaster Laboratories must operate under the same strict quality procedures, LIMS, centralized billing system and online data access portal that are used across all 28 EBPT global locations to drive value to clients and ensure their success. Electronic Lab Notebook (ELN) has become a must-have piece of this overall solution.
The key benefits to using 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.
Eurofins Lancaster Laboratories has been using ELN since 2013 for an ever-increasing portion of our testing. We have developed a suite of ELN experiment 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 ELN-based 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.
This ELN solution is being rolled-out in reusable form to all Eurofins BioPharma Product Testing 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).
Our ELN enforces standardization of documentation practices, via benefits such as context-specific access to entry fields and per-field programmatic business rules. It’s not just a freeform notebook that happens to be electronic. 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.
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 bio/ pharmaceutical industry. This is a broadly-featured, 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.
What 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.
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.