What Is LIMS?

What Is a LIMS?

LIMS stands for Laboratory Information Management System — software that automates and manages laboratory routines, controlling the entire sample lifecycle, tracking results, and ensuring compliance with regulatory standards such as ISO/IEC 17025.

In practice, a LIMS manages and controls all information related to laboratory activities: sample tracking, experimental data management, supply management, process automation, and compliance with regulations and quality standards.

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These systems are designed to manage and track all laboratory processes, while integrating seamlessly with other software and instruments used in day-to-day lab operations.

Various types of laboratories can benefit from a LIMS, such as agricultural and environmental labs, quality control labs in manufacturing industries (food, pharmaceuticals, cement, biotechnology, textiles, etc.), calibration labs, and service labs. Whenever there are concerns about regulatory requirements, data complexity, or sample volume, a LIMS can help.

A LIMS helps transform complex laboratory work, making it simpler, faster, and easier. The digital efficiency provided by LIMS systems can result in a 30% reduction in time, cost, and effort indicators for the laboratory.

Understanding what a LIMS does and what it can deliver for your laboratory is essential. In the video below, we present more information about LIMS and the capabilities of this type of system. Check out this summary:

How Does a LIMS Help Laboratories?

Data Management

A LIMS stores and organizes data generated during experiments, tests, or research. Lab staff can easily access and retrieve this data, improving data integrity and making analysis easier.

In addition, a LIMS makes it possible to manage the entire sample lifecycle, track sample location, and even monitor environmental conditions to ensure samples are not compromised along the way.

Workflow Automation

A LIMS automates repetitive tasks and workflows and tracks whether received samples are processed according to standard operating procedures (SOPs), reducing manual data entry and minimizing human error. This improves efficiency and productivity in the laboratory. With a LIMS, it’s possible to automate sample registration, labeling, storage, and data analysis.

In addition, a LIMS lets you schedule routine tasks such as sample preparation, data analysis, and equipment maintenance, and assign them to individual team members or teams. You can also automatically generate alerts for upcoming tasks and adjust schedules based on priorities or the availability of equipment and/or resources.

Compliance and Regulations

A LIMS makes it possible to maintain complete and accurate records of all laboratory activities, from sample tracking to analysis results. Audit trails and user access controls prevent data manipulation and ensure the integrity of laboratory operations, supporting compliance with Good Laboratory Practice (GLP).

In addition, to support Good Manufacturing Practice (GMP), a LIMS lets you optimize manufacturing workflows by automating data entry and enabling real-time monitoring of critical processes. You’ll also be able to implement quality control measures such as raw material tracking, manufacturing process validation, and product traceability assurance.

Ultimately, a LIMS equips your laboratory to meet regulatory requirements such as FDA 21 CFR Part 11, RDC No. 658/2022 from Anvisa (Brazil’s National Health Surveillance Agency), and ISO/IEC 17025, by documenting quality control measures and improving the traceability and transparency of reports — streamlining internal and external audit processes.

Quality Assurance

A LIMS can enforce quality control measures and support compliance with regulatory requirements, ensuring that laboratory processes meet established standards and guidelines. It promptly flags out-of-specification values in real time, ensuring that all results are accurate before being released, whether to customers or regulatory authorities.

Reporting and Analytics

A LIMS provides an interactive, real-time view of laboratory data. It uses Business Intelligence tools to turn data into charts, tables, and key performance indicators (KPIs), enabling fast, informed analysis of laboratory operations.

Inventory Management

A LIMS helps manage laboratory supplies, enabling precise control over stock levels and avoiding excess or shortages. This ensures resources are available when needed and helps prevent waste.

In addition, the LIMS automates the procurement process by generating alerts for the purchasing team when supply levels reach a critical point, enabling timely, efficient replenishment.

See a LIMS in Practice

Want to see how this works beyond the theory? See how Laboratórios Bagó cut batch release time from 3 days to 1 with a LIMS, or download the Complete Guide to Implementing a LIMS to plan its adoption in your laboratory.

If you’re comparing alternatives, such as spreadsheets or your ERP’s quality module, check out our comparison between spreadsheets, in-house systems, ERP/QM, and a dedicated LIMS.

How a LIMS Works: From Sample Intake to Disposal

A LIMS works by chaining six stages around a single sample: intake with a unique identifier, assignment of the current method, testing against a recorded instrument and analyst, review of the result, release of the report, and retention or disposal. Each stage records who carried it out and when, and that is what makes the chain auditable months later.

1. Sample intake. The sample is registered with a unique identifier that ties it to its collection point, batch, or client. From that moment on, the identifier is the reference used everywhere — not a file name and not a row in a spreadsheet.
2. Method assignment. The system applies the method and the version in force on the date of the test, instead of leaving the choice to whoever happens to run it.
3. Testing. The result is recorded against the instrument used and the analyst who performed it. Where the instrument is connected, the value is imported directly instead of being transcribed — manual transcription is one of the leading sources of error in laboratories.
4. Review. The result is reviewed before it leaves the laboratory, and the system records who performed the test and who reviewed it as separate facts.
5. Report release. The report is built from those same records, with no values re-keyed between systems.
6. Retention and disposal. The sample is held for as long as the laboratory’s policy requires, and its disposal is recorded — which closes the chain that started at intake.

What this flow does not do: it does not replace the analytical method, it does not interpret the result on the analyst’s behalf, and it does not fix a test that was run badly. Its job is to keep together information that normally lives in separate systems. That is where it saves work — not in the measurement itself.

The flow is the same in a food, pharmaceutical, or contract testing laboratory. What changes are the methods, the acceptance criteria, and the standards you have to demonstrate. See how it applies by sector.

LIMS vs. LIS: What Sits at the Centre of the System

The short answer: a LIMS is built around the sample, and a LIS (Laboratory Information System) is built around the patient. That single difference decides which one fits, and buying the wrong category is the most common evaluation mistake.

A LIS is designed for clinical and human-analysis laboratories, where the record follows a person through orders, results, and history. A LIMS is designed for testing routines where the object is a sample — a production batch, a raw material, a water or soil sample — and where what has to be demonstrated later is the method, the instrument, and the analyst behind each result. An industrial laboratory that buys a LIS ends up forcing a batch to fit a record designed for patients.

This is a separate question from spreadsheets, in-house systems, and the quality module of an ERP, which we compare in detail in the laboratory quality management software comparison.

Frequently Asked Questions

What’s the Difference Between a LIMS and an ERP?

An ERP manages the company’s operations as a whole — finance, inventory, sales. A LIMS specializes in the laboratory’s technical routine: sample tracking, test data, method validation, and regulatory compliance. Many companies use both in an integrated way, with the LIMS feeding quality data into the ERP.

The difference that matters in practice is one of data modelling. The central object of an ERP is the batch or the production order; the central object of a LIMS is the sample. An ERP records that a batch was approved, but it does not hold the method applied, the version of that method, the instrument used or the calibration in force on the date of the test. Without those four fields linked to the result, you can register a nonconformity but you cannot demonstrate that the corrective action addressed its cause. That is why the usual architecture is not a choice between the two but an integration, and laboratories running both tend to set one boundary rule: the data is born in the LIMS, and the ERP receives only the already validated result, never the other way around.

Is a LIMS Only for Large Laboratories?

No. Laboratories of any size that deal with sample volume, regulatory requirements, or the need for traceability benefit from a LIMS — including small labs that currently rely on spreadsheets and suffer from rework and lack of standardization.

The criterion that actually decides is not the size of the team — it is how often someone has to reconstruct the history of a sample. A laboratory with three analysts that issues reports to external clients, or operates under an accredited standard, faces that every week; a larger laboratory running only internal monitoring tests may not. The practical test is simple: pick a sample from six months ago at random and time how long it takes to gather the method, the version applied, the instrument with valid calibration on that date, who ran it and the release decision. If that means opening more than one source, or depends on someone who was there at the time, the cost already exists and is being paid in qualified staff hours.

How Long Does It Take to Implement a LIMS?

It varies with the scope and complexity of the laboratory’s processes, but typical implementations range from a few weeks to a few months. The Complete Guide to Implementing a LIMS details the steps to plan this timeline more precisely.

What determines the range is the initial scope, not the size of the laboratory. Starting with the two or three highest-volume tests usually delivers in weeks; trying to cover the whole operation in the first wave is the most common reason a project stalls before its first delivery. In an accredited environment there is an additional factor: the validation protocol, which grows with scope — another reason to start narrow. Three decisions define the real schedule: which tests go into the first wave, what is migrated from the old system and what stays available for consultation only, and from which date the new system becomes the official source. It is worth allowing time to define who answers day-to-day questions in the first week of use, which is when the team decides whether it adopts the tool or returns to the old method.

Does a LIMS Run in the Cloud (SaaS), or Does It Require Its Own Server?

Both models exist. Cloud-based (SaaS) LIMS eliminates the need for in-house infrastructure and reduces upfront cost; on-premise LIMS gives more control over where data resides, which matters for some regulated sectors. The choice depends on the laboratory’s IT policy and compliance requirements.

Three questions usually settle it. Is there a written data-residency requirement? Does the IT team have the capacity to maintain a server, a tested backup and a recovery plan? And what is the tolerance for downtime, given that on-premise it becomes an internal responsibility? In both models the audit-trail and access-control requirements are identical, so this is rarely a compliance decision in itself. One point tends to go unnoticed in the comparison: on-premise, testing that the backup actually restores becomes an internal task — and a backup that has never been restored is not a backup. Cloud shifts that burden to the supplier, which is often the real reason smaller laboratories choose it.

Does Having a LIMS Guarantee ISO/IEC 17025 Accreditation?

No — accreditation depends on an audit and compliance with all the standard’s requirements, not just technology. But a LIMS eases compliance by automating traceability, document control, and audit trails, which are central to 17025 requirements.

What a LIMS changes is the cost of demonstrating conformity. The standard requires records that allow every result to be reconstructed, and evidence that controls were analysed and not merely executed; with scattered records that is still possible, but the cost of each demonstration is high and grows with volume. The distinction is worth stating plainly: an accredited laboratory does not have different technical obligations from a competent laboratory that has chosen not to seek accreditation. It has the additional obligation of demonstrating that competence at any moment, for a sample chosen by someone else, with recoverable evidence. The practical maturity indicator, then, is not owning the system — it is how long the laboratory takes to answer the auditor with the evidence in hand.

How Does a LIMS Help with Audit Preparation?

By centralizing records, document versioning, and calibration and results history in a single system, with an automatic audit trail — reducing preparation time and the risk of nonconformities due to incomplete or outdated documentation.

In practice the gain comes from four mechanisms: a unique sample identifier traceable back to collection; a link between the result, the method applied and the instrument with calibration valid on that date; an audit trail recording the previous value, the author and the reason for every change; and a link between a nonconformity and the data that gave rise to it. The last two account for most findings in laboratory audits. When a value is corrected in a spreadsheet the previous value disappears, and the record loses the reconstruction capability the standard requires. A cheap test before the audit: ask someone who did not take part in the test to reconstruct a randomly chosen sample, and time it — the auditor will hit the same obstacle.

Does a LIMS Integrate with Laboratory Equipment?

Yes. Most modern LIMS platforms connect to balances, chromatographs, spectrometers, and other instruments to import results automatically, eliminating manual transcription — one of the leading sources of error in laboratories.

Integration can happen through capture of the file the instrument generates, through serial or network communication, or through middleware when the instrument is older. Two things matter more than the list of supported equipment. The first is whether the integration stamps the instrument identifier and the calibration in force alongside the result, because that is what sustains metrological traceability. The second is what happens when the instrument returns an out-of-range value: if the path for that exception does not exist in the system, the team will create one outside it. Before signing, it is worth timing the entry flow for the laboratory’s most repetitive test — if it takes too many screens, the team goes back to the spreadsheet, however good the rest of the system is.

How Much Does a LIMS Cost?

Cost varies by number of users, features, and deployment model (cloud or on-premise). To compare this against the cost of maintaining manual processes or spreadsheets, see our guide on LIMS pricing, value, and ROI.

The comparison that is usually missing is against the current cost, not against zero. Before looking at proposals, it is worth measuring for one week how much time the team spends looking for samples, retyping results, gathering evidence for audits and repeating tests because of transcription errors. That number is what is already being paid in qualified staff hours, and it is the honest basis for comparison. A second factor weighs more than it usually appears: how licences are counted. In laboratories with rotating shifts, field sampling and occasional reviewers, the number of people who need access is far larger than the number connected at the same time. A third item is often left out of the initial estimate: the validation time required in an accredited environment, which grows with the scope of the first wave.

Does a LIMS Support Laboratories Operating in More Than One Country or Language?

Yes. Solutions like Actiz LIMS support multiple languages and simultaneous operations across different countries — important for regional or multinational laboratory groups that need standardized reports for each location.

Three requirements separate what genuinely works from what merely has a translated interface. The first is language per user rather than per installation: the same laboratory may have analysts working in Portuguese while a client receives the report in Spanish. The second is the coexistence of different regulatory requirements in one system — a plant answering to one agency and another answering to a different one need distinct workflows without duplicating the method registry. The third is the most overlooked: time zone in the date and time stamp, because an audit trail loses evidential value if the recorded time cannot be interpreted unambiguously. For groups with several plants, it is also worth checking whether consolidated reporting can compare units without manual export.

What Data Does a LIMS Record for Traceability Purposes?

Typically: sample identification and history, methods used, results, who performed and reviewed each step, the date and time of each action, and any deviation or nonconformity recorded — all linked and searchable at any time.

The minimum set that allows a result to be reconstructed is: the sample identifier and its history since collection, the method applied and the version in force on that date, the instrument used with its valid calibration, who executed and who reviewed, the date and time of each action, any repeats with their justification, and the release decision. The standard does not ask for a list of fields — it asks that the result be reconstructable. The test is direct: choose a sample at random from more than a year ago and try to assemble that whole chain. If any link depends on someone’s memory, a separate folder or a parallel spreadsheet, the record does not support the demonstration, even if each piece of data exists somewhere in isolation.

Can You Migrate from Excel Spreadsheets to a LIMS Without Losing Historical Data?

Yes. Most implementations include a historical data migration step. It’s important to map and clean this data before migration, since spreadsheets frequently contain inconsistencies that shouldn’t be replicated in the new system.

The common mistake is to treat migration as a file transfer. Old spreadsheets tend to carry inconsistent units, method names written several different ways, duplicates, and cells overwritten without a trace. Migrating without cleaning replicates the problem inside the new system and, worse, lends an appearance of reliability to data that does not have it. Three decisions need to be made in writing beforehand: what is actually migrated, what remains available for consultation only in the old format, and from which date the new system is the official source. That last one is the most frequently forgotten and produces the most uncomfortable audit finding, because keeping both live allows two different answers to the same question. A good practice is to migrate a short period first and check it against the original.

Who Should Be Involved in Selecting and Implementing a LIMS?

Ideally, the laboratory’s technical team (who will use the system daily), quality assurance (who is accountable for compliance), and IT (infrastructure and security). Involving these three groups from the evaluation phase onward reduces rework and adoption resistance.

There is one role whose buy-in weighs more than the hierarchy suggests: the bench analyst. That is the person who records the data at source, and the only one able to hollow out an approved project without saying no in any meeting — simply by keeping the parallel spreadsheet alive. Involving the people who operate the system before the decision, with the laboratory’s genuinely difficult cases, is requirements gathering rather than courtesy. During evaluation it is worth having the demonstration driven by your own team, using the cases the senior analysts consider too specific, instead of the supplier’s sample data. Exceptions are where systems differ; the happy path looks the same in every demo.

How Much Does ISO/IEC 17025 Accreditation Cost, Beyond the LIMS?

Accreditation cost varies by accrediting body, testing scope, and corrective actions needed before the audit — typically higher than the cost of the LIMS itself. Our ISO/IEC 17025 accreditation cost worksheet helps estimate this investment.

The cost splits into parts that are rarely budgeted together: the accreditation body’s fee and the surveillance audits, calibration and qualification of equipment, participation in proficiency testing, staff time spent building and maintaining the documentation, and the cost of the corrections raised at the initial audit. That last one is the most unpredictable and the item that most often delays the schedule, because it depends on the current state of the records. It is worth budgeting recalibration and equipment qualification separately, since they tend to be the single largest line and carry their own scheduling lead time. Proficiency testing has its own calendar too, so a scheme that only runs twice a year can set the pace of the whole project if it is remembered late. The practical consequence is that the accreditation budget is less a single figure than a schedule: each of these parts has a lead time of its own, and the ones with external providers cannot be compressed by adding effort internally.

The practical effect, described by someone who uses the system every day:

After I got to know Actiz, my life changed. With the implementation of the Actiz system, we have much more agility in the sales team, in the laboratory team and in generating results, in addition to being very good to have them as partners. The entire Actiz team is very well prepared and the Onboarding team is always there to answer our questions. I can only thank Actiz for appearing in my path and solving almost 100% of my problems.

Júlia Machado, Operations Coordinator — SafraLab