What is an electronic lab notebook (ELN), and what should it do in a GxP lab?

1What an ELN is.

An electronic lab notebook (ELN) is the software a laboratory uses in place of a bound paper notebook. Scientists record what they did, the samples and materials they used, their observations, calculations and results, as the work happens. No regulation defines an ELN. The rules attach to the records it holds, not to the medium: FDA states that the requirements for record retention and review “do not differ depending on the data format”.¹

Which rules apply depends on the work. FDA’s good laboratory practice regulations, 21 CFR Part 58, cover nonclinical laboratory studies that support or are intended to support applications for research or marketing permits.² Laboratory testing under drug CGMP has to keep the records 21 CFR 211.194 lists.³ When records those rules require are kept electronically, 21 CFR Part 11 sets the controls the system needs.⁴ Early research outside those rules isn’t bound by them, but its knowledge still counts later: ICH Q10 expects product and process knowledge to be managed “from development through the commercial life of the product”.⁵

2What a regulated lab record has to show.

The GLP and GMP regulations set out what a laboratory record must contain and how it must be kept. An ELN used for that work has to make each of these the default rather than a matter of discipline.

The sources are 21 CFR 58.130⁶, 211.194³, 58.190⁷ and EU GMP Chapter 4.⁸ Part 58 says raw data may include “computer printouts, magnetic media” and “recorded data from automated instruments”.⁹ In the EU, Chapter 4 asks users of electronic records to define which data are raw data, and at least “all data on which quality decisions are based”.⁸

3Where paper notebooks and thin ELNs fall short.

A notebook that holds only what the scientist wrote down isn’t the complete record when the data came from an instrument. FDA says a printout of a dynamic electronic record, such as an FT-IR spectral file that can be reprocessed, “would not satisfy CGMP requirements to retain original records or true copies”.¹ It has said the same of printed chromatograms, which generally leave out the injection sequence, instrument method, integration method and audit trail.¹⁰ MHRA is as direct: where data was captured in a dynamic state and generated electronically, “paper copies cannot be considered as ‘raw data’”.¹¹

The same gap opens in an ELN that keeps a typed summary or a pasted PDF while the original file stays on the instrument PC. FDA doesn’t accept data recorded “on pieces of paper that will be discarded after the data are transcribed to a permanent laboratory notebook”, and notes that a system such as a LIMS can be designed to save automatically after each entry, much as each entry on paper is recorded indelibly at the time.¹ Where a record is part paper and part electronic, MHRA expects it to be “clearly documented what constitutes the whole data set”.¹¹ PIC/S discourages such hybrid systems, which “should be replaced whenever possible”.¹²

4What a GxP ELN should do.

FDA’s reason for individual logins is that when credentials are shared, “a unique individual cannot be identified”, and it expects blank forms, “electronic worksheets, laboratory notebooks” included, to be controlled by the quality unit or another document control method.¹ Part 11 requires audit trails that don’t obscure what was recorded before, and copies of records in human-readable and electronic form for FDA to inspect.⁴ A signed record must show the signer’s printed name, the date and time and the meaning of the signature.¹³ Annex 11 asks for an additional check on critical data entered by hand, and for stored data to stay accessible, readable and accurate throughout the retention period.¹⁴

Validation covers the workflow, not just the product. FDA treats each CGMP workflow on a system as “an intended use of a computer system to be checked through validation”, with effort “commensurate with the risk”. Its example is an MES: qualifying the platform doesn’t show that a given master record’s calculations are correct, so a notebook template that calculates needs the same check.¹ Annex 11 bases the extent of validation on “a justified and documented risk assessment”.¹⁴ Where one system runs both CGMP and non-CGMP work, FDA expects the potential for the non-CGMP functions to affect CGMP operations to be “assessed and mitigated appropriately”.¹

Where the notebook stops and the laboratory information management system begins is a separate choice, set out in LIMS vs ELN.

5How it runs in Seal.

In Seal the notebook is structured. Each protocol defines its fields, units, calculations and required inputs, and each experiment keeps the protocol version, the values entered and the original results, linked to the samples, reagent lots and equipment it used. A later revision of a protocol doesn’t rewrite earlier runs, and a changed calculation goes through change control with its requirements, verification and approval kept in Seal. See the electronic lab notebook.

The notebook sits on the same platform as the LIMS, batch records and quality system, so a method carries into controlled QC and manufacturing with its evidence rather than being written up again; analytical development shows that path. The ELN comparison lists what to check when choosing one.