LIMS Basics for Accredited Laboratories

What is a LIMS?

A LIMS (Laboratory Information Management System) tracks the entire sample lifecycle—from registration to the final test report. This page explains what a LIMS does, which modules it includes, and what ISO/IEC 17025 actually requires.

The LIMS definition—and what the standard says

A LIMS (laboratory information management system) is the central software of a laboratory: it maps the entire journey of a sample—from registration and testing to the final report—and makes every step in between traceable. ERP for production, CRM for sales, LIMS for the lab.

ERP for production, CRM for sales—a LIMS for the lab.

That’s how we explain it in every initial conversation, because it immediately puts things in context: a dedicated software category for a dedicated business function. A LIMS is the tool for digitizing a laboratory—it tracks each sample’s journey and records who did what and when.

What the standard requires—and why a Word document still isn’t enough

Section 7.11 of ISO/IEC 17025 does not require a product called a “LIMS.” The standard deliberately uses the broader term “laboratory information management system”—Note 1 to 7.11.2 even explicitly clarifies that this includes non-computerized systems, which could, in principle, mean paper or Word.

At the same time, the standard requires (7.11.3) protection against unauthorized access, tampering, and loss; a suitable operating environment; continuous data integrity; and complete records of system failures and corrective actions—throughout the entire lifecycle of each individual sample. In practice, meeting all these requirements with paper or Excel is no longer feasible without disproportionate effort. This is precisely the gap a commercial LIMS fills.

DIN EN ISO/IEC 17025:2018, Sections 7.11.1–7.11.6 · LIMS-Forum, Dr. Roman Klinkner

What does a LIMS actually do?

A LIMS guides every sample through six steps. This workflow is identical across industries—whether water analysis, pharma QC, or materials testing. Only test methods and additional regulatory requirements differ.

  1. 1
    Sample registration
    The sample, client, and scope of testing are recorded upon receipt—with a unique ID based on your numbering system and a barcode or QR code label. Explore sample management
  2. 2
    Defining the scope of testing
    Define which parameters to test and which methods to use—with sample templates and test packages instead of individual selections.
  3. 3
    Sample routing
    Assignment to instruments, methods, and responsible staff, visible in daily schedules and worklists. Explore process management
  4. 4
    Results capture
    Manually through the data entry screen or automatically through instrument integration—measurement values flow directly into the system instead of being transcribed.
  5. 5
    Results calculation
    Formulas, plausibility checks, and comparisons against limits and specifications. Deviations are highlighted in color.
  6. 6
    Results reporting
    Formatted in accordance with standards, version-controlled, approved through a two-person review process, and electronically signed. Explore test reports

Six-step workflow based on Dr. Roman Klinkner, LIMS-Forum · Implemented in Labordatenbank

Which modules make up a LIMS?

A complete LIMS consists of four building blocks, weighted differently depending on the type of laboratory. A contract laboratory requires different priorities than a QA laboratory in production—yet the core functionality is the same for both.

Core functionality

Sample management, customer management with CRM, test reports, quotes, and invoices. These are the essentials every laboratory needs. View all features

Quality management modules

Document control, test equipment management, material and batch management, process management, training plans, competency matrices, 8D reports, and supplier evaluation. Explore document control

Service laboratory modules

Formulation management, stability and storage studies, and chemical and hazardous substance management—relevant for contract and development laboratories.

Specialized features

Electronic lab notebook (ELN), interfaces to ERP systems such as SAP or Microsoft Dynamics, a customer portal, and AI integration. Explore AI integration

Module taxonomy based on Dr. Roman Klinkner, LIMS-Forum

LIMS, Excel, or a QMS?

Two distinctions that come up in almost every selection process—and determine whether a lab ends up running one system or three.

LIMS or Excel?

Excel is not a LIMS—and that becomes an issue by the time your accreditation audit comes around. Three pain points we regularly encounter in RFPs and discussions:

  • Validation requirements: Spreadsheets with formulas are considered custom-developed software and would each need to be validated and controlled—a requirement that is difficult to meet consistently in practice.
  • Version chaos: Who changed which cell, and when? Without an audit trail, there is no way to reconstruct the changes—and that is exactly what assessors ask first.
  • Lost raw data: Once a file is overwritten, the original value is gone.

More than half of our customers started there: Excel, Word, Access, or paper. For us, this transition is the norm, not the exception.

LIMS or a quality management system?

The question quality managers ask most often: “Isn't a standalone quality management system enough?” The answer depends on where the system originated.

CAQ systems (computer-aided quality) typically originate in mechanical engineering and the automotive industry and are tailored to ISO 9001 and manufacturing processes: incoming goods inspection, complaints, and monitoring inspection and measuring equipment in production.

A LIMS also covers these quality management functions, but is additionally designed for day-to-day laboratory work: sample flow, methods, result calculations, and the evidence required by ISO/IEC 17025. For a laboratory, a LIMS with integrated quality management is usually the leaner solution—one application instead of two systems that need to be kept in sync.

RFP requirements catalogs · CAQ classification based on Dr. Roman Klinkner · internal competitive statistics (n=105)

LIMS and ISO 17025: What the standard requires

Section 7.11 of ISO/IEC 17025 describes four requirements for laboratory information management. Here is how they are implemented in LDB LIMS:

  • ✓
    Protection against unauthorized access
    Roles and permissions matrix for each employee, group, or role; critical permissions require SSO, a passkey, or MFA. Explore access permissions
  • ✓
    Protection against tampering and loss
    A complete audit trail with the user, timestamp, and original value—tamper-protected and fully text-searchable. Explore the audit trail
  • ✓
    Suitable operating environment
    Hosted in the ISO 27001-certified AWS data center in Frankfurt across three Availability Zones. Explore data security
  • ✓
    Documented validation
    Validation tests run automatically every week and before each update; each run is permanently stored as a PDF report. Explore validation

An important distinction: A LIMS is not required for accreditation. The standard specifies capabilities, not a product. In practice, however, a dedicated LIMS is the most reliable way to demonstrate those capabilities during an audit—because audit trails, access permissions, and versioning are core features rather than additional measures.

DIN EN ISO/IEC 17025:2018, Section 7.11.3 · DAkkS assessment practice

Cloud and AI: two questions every laboratory asks

When it comes to deployment models and AI, marketing quickly diverges from substance. We address both openly—including what we deliberately choose not to offer.

Cloud LIMS or your own server?

Labordatenbank runs exclusively as a cloud service—in the AWS data center in Frankfurt, across three availability zones. You access it through your browser, with full functionality on Windows, macOS, Linux, tablets, and smartphones.

This eliminates the operational workload that a system hosted on your own server places on your IT team: we handle updates, backups, resilience, and security patches. Smaller laboratories without their own IT department benefit the most. Explore the deployment model

What AI actually does in a LIMS

AI appears in almost every software brochure these days. Here is exactly what it means in Labordatenbank: AI imports extract data from unstructured documents, such as sampling records or external laboratory reports, and assign it to the correct samples. The Query Explorer answers data analysis questions in everyday language, without SQL. The Audit Assistant checks documents against the requirements of standards.

What matters for accredited laboratories: you choose the model yourself, your data is not used for training, and every AI action is recorded in the audit trail. Explore AI integration

General Data Security Guidelines (ADSR) · SaaS deployment model

What LDB delivers

26.4 %

less time spent in everyday lab work

26 %

faster sample turnaround

> 50 %

time saved in individual laboratories

4.3 / 5

satisfaction after the rollout

Customer survey conducted as part of our ISO 9001 certification, 2025 and 2026 (50 % response rate). Average values across all participating laboratories; time savings range from 10 % to over 50 % depending on the laboratory.

Frequently asked questions about LIMS

A LIMS (Laboratory Information Management System) is the central software of a laboratory. It maps the entire journey of a sample—from registration, test scope, distribution, and result entry through to the finished report—and makes every step traceable. Comparable to an ERP for production or a CRM for sales, just for the lab.
It guides every sample through six steps: sample registration, defining the test scope, sample distribution, result entry, result calculation, and the test report. Every entry and change is logged with a user and timestamp.
LIMS stands for Laboratory Information Management System. In Clause 7.11, ISO 17025 uses the more general term “laboratory information management system.”
A pure QM or CAQ system typically originates from mechanical engineering and automotive and covers ISO 9001 processes: incoming goods inspection, complaints, and test equipment monitoring. A LIMS also covers these functions, but additionally maps the actual lab work—sample flow, methods, result calculation—and fulfills the documentation requirements of ISO 17025.
No. The standard does not prescribe a specific product and, in Note 1 to Clause 7.11.2, explicitly permits non-computerized systems as well. However, it does require specific capabilities: protection against unauthorized access, protection against tampering and loss, data integrity, and seamless record-keeping. Meeting this combination with paper or Excel is no longer feasible with reasonable effort.
A clear sign is when Excel spreadsheets, paper lists, or multiple standalone solutions lead to version chaos, a missing audit trail, or extra effort during audits. More than half of our customers did not have a professional LIMS prior to implementation, relying instead on Excel, Word, Access, or paper.
Spreadsheets with formulas are considered custom-developed software and would have to be individually validated and controlled. In addition, changes cannot be reconstructed without an audit trail, and once a file is overwritten, the original value is lost. That is exactly what auditors ask about first.
Four building blocks: core functionality (sample management, customer management, test reports, billing), QM modules (document control, test equipment, materials, training, 8D reports), service lab modules (formulations, stability studies, chemicals), and specialized features (ELN, ERP interfaces, customer portal, AI).
Ongoing costs depend on the number of users and the modules selected. More decisive is usually the implementation effort: We start with a kickoff workshop and guide the rollout with topic-specific onboarding workshops. We discuss the typical process, effort, and timeline openly right during the demo.
That depends on the scope—from a few weeks for a small lab with a standard configuration to several months with multiple interfaces and legacy data migration. We plan the process together during the kickoff, based on experience from more than 200 LIMS implementations.
Konrad Wagner, LDB Labordatenbank GmbH

Konrad Wagner

konrad@labordatenbank.de
+49 (151) 22 33 98 44
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