Pharma DEM ELN is a trusted, modern informatics solution that increases efficiency and productivity. We welcome the opportunity to partner with pharma companies so that scientists can focus on science rather than data formatting.

An Electronic Lab Notebook (ELN) is a software tool that in its most basic form replicates an interface much like a page in a paper lab notebook.

ELNs offer several advantages over traditional paper notebooks; they facilitate good data management practices, providing for data security, auditing, and collaboration.

Pharma R&D needs to unify and harmonize experimental data in the cloud/server, in order to fully capitalize on the power of AI and data science. In turn, AI and data science will uncover insights that will accelerate discovery and development of therapeutics that extend and enhance human life.

FDA Title 21 CFR Part 11

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 is covered in Title 21 CFR Part 11 of the Code of Federal Regulations.

To ensure this is the case, your ELN must do the following:

Your data must be digitally recorded using a closed system that restricts access, and ensuring that only authorized personnel can access your records. 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 digital lab book must also be able to create readable copies of your notes at any time, for example in pdf format. In addition, these copies must also be archived for future retrieval.

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.

Finally, the FDA is also very specific about how electronic signatures should be instituted to prevent fraudulent use. 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.