![]() After all, there are so many people that are stakeholders in selecting an electronic lab notebook: the lab manager, the Head of R&D, the IT manager, the QA/QM manager, post-doc researchers, etc. For witnessing documents, it is required to securely record who is witnessing and at which date and time, in a manner that wouldn’t allow a signer to easily repudiate the signed record as not being genuine.Īt least until the ELN industry reaches a more mature stage, it is unlikely that every researcher can find the perfect ELN that suits the needs of their team. Finally, the FDA is also very specific about how electronic signatures should be instituted to prevent fraudulent use.Probably not very surprising, but the FDA also mandates that electronic notes have an audit trail with time stamps, which cannot be edit or deleted.In addition, these copies must also be archived for future retrieval. Your digital lab book must also be able to create readable copies of your notes at any time, for example in pdf format.This is generally achieved by most commercial ELNs using a secure login with username and password, but do watch out for tools which allow for public sharing of documentation. Your data must be digitally recorded using a closed system that restricts access, and ensuring that only authorized personnel can access your records.To ensure this is the case, your ELN must do the following: This is covered in Title 21 CFR Part 11 of the Code of Federal Regulations. Next, if your lab is seeking to produce pharmaceutical drugs, vaccines, bio-pharmaceuticals or any other product or treatment regulated by the Food and Drug Administration (FDA), you will need to make sure that your digital records are considered as trustworthy and reliable to paper records. This can be prevented through restricted management rights, a full audit trail including version control and timestamps, secure data transfer, and organizationally defined controls on data availability, data retention, and data deletion. Integrity: Few things are more important than ensuring that your data cannot be altered or deleted by unauthorized parties.Authenticity: Your digital lab book should guarantee the reliability of data transfers through multi-level authentication processes, secure user identification, electronic signatures, and a migration plan.At a minimum, this includes strong user right controls (who can see what), robust encryption standards, as well as confidentiality procedures and agreements. Confidentiality: Lab notebook software must employ procedures that keep all stored records protected from unauthorized parties.Make sure to ask your ELN software provider how often the data is backed up, how it protects it data center, and which exporting methods are available. Security: The ELN must be able to archive, securely store, protect and extract the data and notes you create.Here are the features an ELN needs to have before you can be assured that you are GLP compliant: There are principles that apply in particular to electronic lab notebooks, which mostly prescribe how data should be stored, secured and managed. Let’s start with the Good Laboratory Practices (GLP) which were introduced by the OECD. A simple but sophisticated search experience, allowing you to retrieve your data by author, tag, unique ID, textual content, timestamp, and/or structured data query (for example, “find all entries tagged as Western Blot where the Embryonic days are equal to 12”). As a researcher or team leader, you should be able to find your research data in seconds. ![]() Mobile and tablet compatibility, as well as responsive design, allowing researchers to use their preferred device to record their experiment notes.This is personally one of my favorite productivity features in Labfolder. Protocol templates which you can re-use to save time on repetitive tasks, and share with your team.You need to ensure that the annotations are created as an image overlay and do not alter the raw data that you uploaded. The ability to import images and add annotations.A spreadsheet tool which allows you to create tables, enter and format data, perform calculations and create graphs within the ELN, as well as import from and export to Excel. ![]() Ideally, the ELN should allow you to import existing Word documents and keep editing them within the tool, and vice versa when exporting from your digital notebook to a Word file.
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