Electronic Notebooks: Implementation and utilization of new technology
Transforming how raw data documentation is managed at Eurofins Lancaster Laboratories
by Travis Emig, Senior Director, Pharmaceutical Services
Eurofins Lancaster Laboratories has recently taken yet another innovative step to continue to improve processes and quality in our laboratory services portfolio by offering Electronic Notebooks (ELN).
As noted by Quality Assurance Manager, Anjan Mittal, benefits of an electronic documentation system for raw data include improved quality and legibility of records. There is real-time elimination of data omission. Template QbD design dictates accurate, complete, and efficient experiments. Data specific to samples, equipment, materials, etc. are captured through validated scanning of bar codes, meaning a single record in LIMS can be used as source information for all subsequent uses. There is automation in creating PDF files for data package delivery.
With customers implementing their own use of ELN based products, and today’s regulatory environment, which is focused on electronic management of records and data integrity, the ELN implementation at Eurofins Lancaster Laboratories aligns with industry expectations for a third-party CRO. This product allows for more integrated partnerships with clients, will open the door for future connectivity with LIMS products, and will drive continued focus on control and integrity of electronic records.
Challenges exist with developing and implementing an ELN system in a CRO operation. Besides the normal challenges any Pharmaceutical organization would face in design and validation of such a product, the CRO environment adds a huge variable, and that is customized requirements for each individual customer. An additional layer of product functionality was created to manage and link client parameters into the ELN product, allowing general experiment templates to be used for various clients. The logistics to procure hardware (laptops, scanners, WiFi) must also be managed.
How has ELN already improved operations for Eurofins Lancaster Laboratories?
Microbiology Manager Harolyn Clow stated, “My area has already achieved a 50% reduction in preventable analyst errors in documentation. The ELN templates essentially check analysts’ work as it is being performed, so errors are identified and prevented before negatively impacting an experiment.”
The laboratories using ELN show appreciable reductions in errors and investigations. They note that raw data is always accessible, no need to locate paper notebooks to retrieve records. Batches and lot numbers for samples are searchable in the ELN system, and the status of test batch information is available in one location.
Further, Pharmaceutical Chemistry Group Leader, Dana Cunningham, added, “Management of reagent preparations has improved significantly, with clear records and labels that allow for direct scanning into an experiment record. As a supervisor, I like having the access to progress of each experiment I have assigned, from initiation through completion, data review, and data package. I have real time ability to view test status and no longer have to track down notebooks.”
How is Eurofins Lancaster Laboratories using the ELN product today?
Microbiology, Water Chemistry, Reagent Preparation, Chemistry and Biologics testing all have several templates in production or development. A team of template developers led by John Jegla works in conjunction with laboratory management to identify opportunities and set requirements for new templates to be generated.
What are next steps in expanding the use of the ELN product?
As expertise with an ELN platform expands, review by exception is a feature that can be incorporated to streamline QA approval. Automated upload of results into LIMS is feasible. Capture of raw data from equipment such as balances is also being developed.
Customers of Eurofins Lancaster Laboratories have already started to see ELN data reports in their final compiled data packages for various testing areas and the expectation is for the utilization of the product to expand tremendously through 2016.
For more information, contact Biopharmaceutical Business Development at 717-656-2300.