![]() ![]() This change access should cascade down to the notebook and related experiments. ![]() Access to the project can be changed after the work is done. by employees, ELN should have role-based privileged access to Project, Notebook, and experiment. For protection against internal theft i.e. In an Ideal ELN, it must protect company IP from possible internal or external theft. Other important and critical security features This archival system can be within ELN or in a secured database behind the company firewall.Ģ. Ideal ELN should support archiving immortalized, time-stamped, unalterable record with all details that were done during the experiment. Organized storage and archival of experiment records.The collaborative work environment provided by ELN allows the organization to create a lot more IP assets in a shorter time span. The ability to pull out sample data easily by project, experiment, or result becomes very critical for building a case in court or simply working with the collaborator to flesh out ownership rights. Ideal ELN should support structuring experimental data in many ways, consistent with the projects, experiments, and results. Knowledge management and strengthening the team with cumulative knowledge of the entire team becomes possible. It helps in the quick sharing of knowledge and knowledge artifacts. It makes it easy to navigate through the pile of information. On the other hand, an electronic system makes it very easy to electronically search the information across various experiments, notebook, and projects. They land up repeating the same research done a few years ago, thus wasting significant cost and precious time on the project, in the paper-based Lab Notebook scenario. The research work done by the previous team, a few years ago, is not known to the current R&D team. Does everyone in R&D get the advantage of this strength of 1500 Scientists Years of expertise? The answer is a big “NO”, in the paper lab notebook scenario. If you have 100 scientists in your R&D, with 15 years of experience each, on average, you have 1500 scientists’ years of experience and expertise in your team. Sharing research project knowledge with multiple scientists is not feasible in a paper notebook environment. Retrieving the paper notebook from physical archives takes a lot of time. Information searchability is a big problem with a paper lab notebook. A structured environment for the projects, experiments, and results.In a collaborative environment where people from multiple teams are working on the same experiment, it becomes very critical to fence off selected projects, experiments to the right people. Role-Based privilege and access to IPĪny established ELN will have the facility of role-based privileged and access system to close off access to all or parts of the experiment.Electronic signatures should be mandated for controlled workflow and complying with the organization’s policies to witnessing the experiments. On the other hand, the audit trail should be available to track the smallest changes to record and chain of custody for the data. Generally, any ELN should have the capability to record user identity, date-time stamp, and any data entered into the system. Electronic Records and signatures as per 21 CFR Part 11Ģ1 CFR Part 11 discusses a lot of features that must be there in any electronic system like “E Lab Notebook”.Must have features when selecting an ELN to protect your IP includes It becomes very important to look at the ‘baseline’ features and security controls that help in protecting the IP. Organizations are looking at the application which can be hosted on the internal or external cloud and in a way facilitate data sharing and data capture across multiple sites. If you are thinking for ELN or thinking to bolster your IP protection, there are many elements to consider in ELN in order to effectively secure IP.Ĭollaborative research is growing continuously. An E Lab Notebook can play a pivotal role in the IP protection strategy by allowing complete, accurate, and witnessed a record of all research. Nowadays, most advanced R&D companies have already shifted to E Lab Notebook to facilitate the R&D team with a common repository of research work to aid collaboration among different teams. If your company is working on cutting edge technology such as gene therapy or novel biologics the entity then considering the Intellectual protection strategy is very much vital for business and can have a direct impact on a company’s future. For any R&D company securing Intellectual Property (IP) is the very critical same time they must be able to document the work they did to prove that the invention substantially performs against the claim. Nomber_key:000349Īs they say, time is money, so is with the pharmaceutical patent. ![]()
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