What is the difference between a LIMS and an ELN?

1What each system is for.

A laboratory information management system (LIMS) is organised around the sample. It registers what arrived, assigns the tests, methods and specification that apply, records each result and sends it for review. An electronic laboratory notebook (ELN) is organised around the experiment. It takes the place of the bound paper notebook: the scientist records the aim, the procedure followed, observations, calculations and conclusions as the work is done.

Neither term is defined in the GMP or GLP regulations, which set requirements for records and controls rather than for kinds of software. FDA’s data integrity guidance names a LIMS as a system that “can be designed to automatically save after each entry”, and lists “electronic worksheets, laboratory notebooks, and MPCRs” among the blank forms the quality unit or another document control method should control.¹ The EU GMP guide expects quality control procedures to cover records “including test worksheets and/or laboratory notebooks”, and says raw data such as laboratory notebooks should be “retained and readily available” in addition to the batch documentation.²

2How the two compare.

The record rows carry the legal weight. A QC test record must contain what 21 CFR 211.194(a) lists: a description of the sample with its source, quantity, lot and dates; each method used; the weight or measure of sample; “a complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation”; every calculation; the result compared with its standard; and the initials or signature of the analyst and of a second person who reviewed the original records.³ EU GMP section 6.17 asks for much the same and adds a clear statement of approval or rejection and a reference to the equipment used.²

For a nonclinical laboratory study, FDA’s GLP regulations define raw data as “any laboratory worksheets, records, memoranda, notes, or exact copies thereof” that result from original observations and are needed to reconstruct the study. Each entry is dated and signed or initialled by the person making it, and a change must not obscure the original entry and must give its reason.⁴

3The same rules apply to both.

Under 21 CFR 211.68(b), changes to records held in a computer system may be made only by authorised personnel, input and output must be checked for accuracy, and backup data must be exact, complete and secure from alteration or loss.⁵ When a record that a predicate rule requires is kept electronically in place of paper, or relied on in electronic form, Part 11 applies.⁶ The system must then be validated, limit access to authorised individuals and keep secure, computer-generated, time-stamped audit trails that do not obscure what was recorded before.⁷ In the EU, Annex 11 applies to “all forms of computerised systems used as part of a GMP regulated activities”.⁸

Validation is for the intended use, not for the product in general. FDA expects each CGMP workflow on a computer system to be validated.¹ The MHRA says accepting vendor-supplied validation data “in isolation of system configuration and users intended use is not acceptable”, and that data transfer should be validated, with an audit trail, so that data are not altered during or after transfer to a worksheet or other application.⁹ Neither system replaces an instrument’s original electronic record: FDA says a printout of a dynamic record, such as an FT-IR spectral file that can be reprocessed, does not satisfy the requirement to keep original records or true copies.¹ The MHRA says moving between paper and computerised systems “will not in itself remove the need for appropriate data integrity controls”, and that a validated system may lower but not eliminate data integrity risk.⁹

4Where GMP begins, and where each fits.

The EU GMP guide says GMP applies from the manufacture of investigational medicinal products, through technology transfer and commercial manufacturing, to product discontinuation. The pharmaceutical quality system can extend to development as ICH Q10 describes, which the guide calls optional.¹⁰ ICH Q10 itself says its content beyond regional GMP requirements is optional.¹¹ An ELN used for discovery research can therefore sit outside GMP, while nonclinical laboratory studies that support an application to FDA fall under Part 58.⁴

Data comes under GMP when it is used for a GMP purpose. FDA’s position is that “when generated to satisfy a CGMP requirement, all data become a CGMP record”.¹ A method developed in an ELN does not become a QC method by being copied into a LIMS: 211.194(a)(2) requires the suitability of every testing method to be “verified under actual conditions of use”,³ and EU GMP says a laboratory that did not perform the original validation should verify that the method is appropriate.²

5Choosing one, the other or both.

Start from the records. If the work is testing samples against specifications to release materials and products or to report stability timepoints, the records are the ones 211.194 and EU GMP Chapter 6 describe, and a LIMS is built around them. If the work is a series of experiments whose design changes from run to run, the record is a notebook, and an ELN is built around that. A laboratory that does both kinds of work may need both.

When they are separate systems, decide which one holds each record. EU GMP Chapter 4 says the relationships and control measures for master documents, official copies, data handling and records need to be stated for hybrid and homogeneous systems alike, and that it should be clear which record relates to each manufacturing activity and where it is kept.¹² Data exchanged between systems should pass built-in checks for correct and secure entry and processing, and validation of a migration should include checks that data are not altered in value or meaning.⁸ The MHRA warns that “the challenges of migrating data are often underestimated”.⁹

6How it runs in Seal.

In Seal the ELN and LIMS share one platform and its sample, material and method records. Scientists develop a method in the ELN, and the approved version comes into QC with its parameters, calculations, system-suitability checks and review requirements, keeping the development evidence that explains those choices. Each QC result keeps its sample, method and specification versions and its instrument file, laboratory review feeds batch disposition, and earlier runs keep the version they used.

You can start with one release test beside the LIMS you already run: Seal reads samples and results from LabWare, LabVantage and SampleManager without writing to them. The LIMS comparison sets out what to check when choosing.