Are we ready for the evolution of electronic laboratory notebooks in regulated bioanalysis?

During the last decade, quite a few bioanalytical laboratories have adopted electronic laboratory notebooks (ELN) in nonregulated and regulated settings [1–3]. The implementation of an ELN in a regulated bioanalysis laboratory requires a significant amount of resources in order to ensure that the design is truly supporting the internal processes of the lab and is validated in compliance with current r egulations. So, what is preventing a bioanalytical laboratory from implementing an ELN? Other than cost, there is really no significant obstacle anymore to fully adopt electronic record keeping due to the fact that both ELN vendors and laboratories gained sufficient expertise in the implementation of these computerized systems [4,5]. The advantages have become very obvious. In a regulated organization, compliance is usually achieved through procedural controls which are still very prone to human error. This can only be prevented through thorough training and building experience. The implementation of an ELN allows the support of procedural controls through more technical controls which can prevent human errors. Therefore, the industry is ready for this evolution, as long as the following key aspects in the implementation of a computerized s ystem like ELN are recognized. As with any computerized system in a regulated organization, the success of an ELN starts with the design. Applying the common V-model or life cycle development model for the implementation of a system [6,7]; the design is critical to ensure that the system can support the internal lab processes in an efficient manner and also ensure data integrity to comply with regulations. Regarding the processes, it is essential that workflow templates within the system are intuitive to use and enable adherence to existing lab procedures. With respect to data integrity, functional requirement specifications in the validation master plan need to clearly define elements such as: