How do you choose a LIMS, and what should LIMS requirements include?

1Start from what a laboratory record must hold.

A LIMS holds the laboratory records GMP requires, so those requirements are the core of its specification. In the US, 21 CFR 211.194(a) says laboratory records shall include “complete data derived from all tests necessary to assure compliance with established specifications and standards”.¹ In the EU, paragraph 6.17 of the GMP guide’s Chapter 6 sets the minimum content of test records.² Together they give the first section of a LIMS user requirements specification.

Chapter 6 adds two requirements that shape reporting rather than storage. Some data, such as test results, yields and environmental controls, should be recorded “in a manner permitting trend evaluation”, with out-of-trend and out-of-specification data investigated. And the quality control department should have ready access to specifications, test procedures, calibration and maintenance records, a procedure for investigating OOS and OOT results, test reports or certificates of analysis, environmental monitoring data and method validation records.² A laboratory accredited to ISO/IEC 17025:2017 adds that standard’s requirements, which ISO describes as covering the “competence, impartiality, and consistent operation of laboratories”.³

2Add the computerised system controls.

EU GMP Annex 11 expects user requirements that describe the system’s required functions, based on documented risk assessment and GMP impact, and traceable through its life.⁴ For a LIMS, the controls that matter most come from a few clauses.

• Only authorised people change records, and input and output are checked for accuracy, under 21 CFR 211.68(b).⁵ FDA recommends restricting the ability to change specifications, data or methods “by technical means where possible”, giving the system administrator role to people independent of the record content, and not sharing logins, because a shared account cannot show who did the work.⁶
• Critical data entered by hand get an additional accuracy check, by a second operator or by validated electronic means.⁴
• Deviations from written specifications, sampling plans or test procedures are recorded and justified, and changes to them are approved by the quality control unit.⁷
• Where records are kept electronically, audit trails and record copies meet 21 CFR 11.10, and each electronic signature shows the signer, the time and its meaning and is linked to its record under 11.50 and 11.70.⁸⁹¹⁰

3Decide where the original instrument data will live.

This requirement decides the architecture. FDA’s data integrity guidance says that electronic records from some instruments “are dynamic”: an FT-IR spectral file can be reprocessed, so a printout or static record of it does not satisfy the requirement to keep original records or true copies.⁶ A LIMS that stores only the reported result does not hold the complete record. Either it stores the original data, or another validated system, such as the instrument’s data system, keeps it and the LIMS links to it. EU GMP asks regulated users to define which electronic data are raw data, and at least “all data on which quality decisions are based”.¹¹

How data get from the instrument matters as much as where they end up. The draft revision of Annex 11, consulted on in 2025 and not yet in force, uses this exact case: transfer of critical data “from a laboratory instrument to a LIMS system” should, where possible, “be based on validated interfaces rather than on manual transcriptions”.¹² PIC/S expects interfaces to be assessed during validation, warns that data held temporarily on an instrument computer can be deleted or altered before transfer, and notes that well-designed, qualified automated transfer “is much more reliable than any manual data transfer”. It suggests a data flow map to see these risks.¹³ List each instrument, its software and what it exports, and make the interface part of the requirements.

4Assess the supplier and plan the validation.

Annex 11 makes the supplier’s competence and reliability “key factors” in selection, bases the need for an audit on risk, and expects regulated users to check that documentation supplied with an off-the-shelf product meets their requirements.⁴ PIC/S asks regulated users to ensure vendors understand GMP and data integrity requirements, and says they “should therefore not place sole reliance on vendor qualification packages”: validation should include tests showing data integrity holds in normal, intended use.¹³

Plan the tests from the requirements. Annex 11 asks for evidence of appropriate test methods and scenarios, considering parameter limits, data limits and error handling, and for checks that migrated data are “not altered in value and/or meaning”.⁴ Before you choose, run one of your own samples through each shortlisted system: receipt, testing with a real instrument file, an out-of-specification result, second-person review and release.

5How it runs in Seal.

Seal’s LIMS comparison lists what to check when choosing: who configures it and how long until a first method runs, whether samples, specifications, stability, OOS investigations, batch records and quality events share one set of records, whether it reads the files your instruments already save, and whether each change is released with acceptance tests while earlier results keep the version they ran under. In Seal, each result is captured as the work runs, with its sample, preparation, method, specification and instrument file attached, and the original instrument file is kept with the result it produced; see the LIMS in Seal.

You can start with one release test, incoming-inspection workflow or stability study in a 48-hour evaluation, alongside the LIMS you already run: Seal reads samples and results from LabWare, LabVantage and SampleManager without writing to them. For a contract laboratory, the contract laboratory LIMS shows each sample inheriting the effective terms of its client’s quality agreement.