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Laboratory Informatics Guide 2020


type, ensure all documentation is current and all collaborators work transparently and from the same document version. Tis means all participants have access to the same data and can see all logged updates and annotations as they happen, with no need for emails introducing delays, different file versions and error margins. Te time-saving potential of this new level of transparency is substantial. In the world of scientific research, many


laboratories hold data that, for regulatory reasons, can’t leave the institution of source. Storing this information in a secure, centralised platform accessible only by authorised personnel delivers the necessary compliance while opening up the new potential for true global collaboration.


Compliance and data integrity With the US Food and Drug Administration (FDA) introducing new guidelines in December 2018 for data integrity in current good manufacturing practice (CGMP), all organisations are advised to implement effective data management strategies. Tese should consider the design, operation and monitoring of systems and controls based on the risk to patient, process and product. Using a high-quality ELN ticks all these


boxes. Because ensuring data integrity is vital to ensure the safety, efficacy and quality of drugs, all laboratories need to comply and, critically, be able to demonstrate their compliance in their documentation. An ELN that documents activity


at the time of performance, creates original or true copies of data, and time and date stamps all records for auditable logging and traceability is the most efficient and resource-effective way to manage compliance. Te automated data management process


makes it easier to find data, troubleshoot issues and establish the suitability of entities for different experimental tasks. It also allows lab assistants to calibrate lab equipment before use, and log and track this calibration for future experiments, facilitating the reproducibility of results.


Moving towards blockchain Te principles of blockchain present interesting potential in a research laboratory environment, as they rule out the possibility of tampering with archived or stored data – which is one of the underlying principles of the FDA guidance. While pre-publication data transparency may not be possible, or is precluded for regulatory reasons, adopting blockchain in data archiving would ensure it is reviewed and verified – and is therefore auditable – throughout the data lifecycle. An ELN that adopts the tried and tested blockchain security measure may present strong data integrity management possibilities for the lab of the future.


Removing entry barriers Looking to the future, it is essential that ELN vendors stay one step ahead of the value curve. In the laboratory environment where


throughput is critical, technology uptake is influenced by weighing up potential value versus the effort required for deployment and integration. Tose companies that can add new value while decreasing the effort required for implementation are set for success. Faster onboarding through creating an


intuitive user experience adds strong value. Tis can include adding a familiar navigation, providing video-led online training, or being able to work within existing files rather than having to import data into a new system. User adoption can be monitored and improved using system analytics – and the findings built into the next generation ELN system.


The future is data With established technologies like ML and blockchain gearing up for use in the laboratory, we are seeing emerging developments in ELNs unlock the potential of the cloud to benefit research. Remote execution of experiments, live information sharing in real time and on a global scale, and standardised data logging are paving the way for new collaboration and dramatically increased productivity. Steve Yemm is CEO at BioData, a Digital


Science company providing lab informatics products – including Electronic Lab Notebook, Lab Inventory, Chemical Registration and Biological Screening solutions – to biopharmaceutical and academic life sciences organisations in addition to other science-based industries. n


www.scientific-computing.com/LIG20


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