Research and biotech labs
Assay development, biobanks and discovery work.
- Sample lineage and aliquot tracking
- Flexible protocols that change weekly
- Freezer and storage location maps
Healthcare / Laboratory Management Software
Laboratory management software development
Research, quality control and specialty labs lose samples to spreadsheets, retype instrument results and cannot show a clean audit trail. Agnotic Technologies builds laboratory management software (LIMS) around your sample lifecycle, instruments and review rules, with 21 CFR Part 11 controls where the lab is regulated.
Part 11
Audit trails and e-signatures where regulated
Chain of custody
Every sample, every handoff recorded
Instrument data
Results captured, not retyped
Trusted by global innovators
Industry Overview
What is laboratory management software?
Laboratory management software, often called a LIMS, tracks samples from receipt to result, records instrument data, runs test workflows and keeps the audit trail a regulated lab must show. Agnotic Technologies builds laboratory management software for research, quality control and specialty labs, with 21 CFR Part 11 controls, instrument interfaces and inventory built around how the lab actually works.
Lab types
Which labs need custom laboratory management software?
Packaged LIMS products fit a standard lab. These labs usually are not standard, and the gap shows up in the workflow.
Quality control labs
Pharma, food and chemical QC under CGMP or similar rules.
- Specification checks and out-of-specification workflow
- Batch and lot linkage to results
- Review and release with electronic signatures
Specialty and esoteric labs
Genomics, toxicology and environmental testing.
- Long multi-step workflows with instrument runs
- Batch plating and run sheets
- Custom result formats and reports
Lab startups
New labs that need a system before the first customer.
- A fixed-scope first release for one workflow
- Instrument interfaces added as equipment arrives
- Controls designed in so accreditation later is not a rebuild
Industry Challenges
Is laboratory management software the same as a LIS?
No. A LIMS is sample-centric; a laboratory information system (LIS) is patient-order-centric and exchanges orders and results with an EHR. Both are often called lab software, and choosing the wrong model is the most expensive early mistake. The signs a lab needs a LIMS rather than a LIS:
The unit of work is a sample, batch or lot, not a patient order from a clinician.
Results are reviewed against specifications or research protocols, not reported to an EHR.
Instruments, reagents, inventory and storage locations need to be tracked alongside the sample.
The regulator is FDA under CGMP or an accreditation body, not CLIA.
If orders arrive from an EHR and results go back to clinicians, you need a laboratory information system instead.
Our Approach
How do we fit the software to the lab?
A LIMS fails when the lab changes its process to match the software. We do the reverse.
Model your sample lifecycle first
States, handoffs and review points mapped with bench staff before any screen is designed.
Instruments feed results
File drops, serial connections or vendor APIs bring instrument data in with the run context, so nothing is retyped.
Controls that match the regulation
Audit trail and electronic signatures where 21 CFR Part 11 applies; lighter controls for research work that does not need them.
Capabilities
What we build into a LIMS
Modules delivered as part of laboratory software development, in the order your lab needs them.
Sample registration and tracking
Barcode labels, chain of custody, aliquots and storage locations.
Test workflows
Protocol steps, batch runs and worklists with status at each bench.
Instrument integration
Result capture from analyzers, sequencers and balances with run metadata.
Review and release
Specification checks, out-of-specification flags and electronic sign-off.
Inventory and reagents
Lot tracking, expiry alerts and consumption per run.
Audit trail and reporting
Who did what and when on every record, plus certificates and run reports.
Engineering Stack
Technologies we use for lab systems
Chosen for data integrity, long support and fit with lab hardware.
Data
PostgreSQLEvent-sourced audit logObject storage for raw instrument files
Instrument interfaces
File watchersSerial and TCP listenersVendor APIs
Apps
Next.jsReactTablet-first bench UI
Infra
AWSAzureOn-premise where the lab requires it
Reference workflow
Which states does a sample move through?
The states we model in most laboratory management software builds, with what the system records at each one. Your lab's names and rules replace these on the scoping call.
| State | Trigger | What is recorded | Who signs |
|---|---|---|---|
| Registered | Sample logged or imported | Source, container, label, storage location | Receiving technician |
| In testing | Assigned to a worklist or run | Protocol version, instrument, reagent lots, operator | Analyst |
| Results captured | Instrument file or manual entry | Raw values, units, run metadata, calculation inputs | Analyst |
| Under review | Specification or protocol check | Pass or fail per test, out-of-specification flags, comments | Reviewer |
| Released | Approval | Final result, report version, electronic signature meaning | Approver |
| Archived or disposed | Retention rule | Disposal record, retained aliquot location | Custodian |
Measured Impact
What decides the scope of a LIMS build?
There is no fixed price. These factors move effort most, and we size each on the scoping call.
Workflows
Distinct test workflows
Each protocol with its own steps, review rules and reports adds configuration and testing.
Instruments
Instruments to interface
Each analyzer or sequencer has its own output format and connection method.
Controls
Part 11 depth
Regulated labs need audit trails, electronic signatures and validation evidence; research labs may not.
Migration
Historical samples and results
Legacy spreadsheets and databases migrated with their history intact.
My Lauren Maternal Health Platform | Built by Agnotic
A HIPAA-ready maternal health platform enabling remote patient monitoring, care coordination, and personalized engagement from pre-pregnancy through postpartum.
Case Study
LERA Health: Compliant Women’s Health App Platform
A women’s health product experience focused on guided care journeys, education, and compliance-aware workflows to support long-term engagement.
Case Study
Use Cases
Where does custom lab software help first?
Typical first releases for the lab types above.
01
Sample tracking replacement
Barcoded samples and storage maps replacing a shared spreadsheet.
02
Instrument result capture
One analyzer connected, with results landing on the sample automatically.
03
QC review and release
Specification checks and sign-off for a single product line.
04
Biobank management
Lineage, consent flags and freezer positions for stored material.
05
Reagent and inventory control
Lot tracking and expiry alerts tied to runs.
06
Run reports and certificates
Versioned reports generated from released results.
Integrations
What does a LIMS connect to?
The systems and hardware a laboratory management system usually talks to.
Instruments
Analyzers, sequencers and balances
Hardware
Barcode printers and scanners
Business
ERP and quality systems
Research
Electronic lab notebooks
Quality
Document management
Security
Identity providers (SSO)
Compliance-First Development Services Backed by Global Standards
We build secure, scalable products designed for privacy, interoperability, and regulatory readiness from day one across every sector we serve.
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, and strict access controls.
Our Edge
Why Global Leaders Choose Us
We combine deep technical expertise with industry-specific knowledge to deliver solutions that aren't just functional, but transformational.
Enterprise-Grade Security
We implement rigorous security protocols and compliance standards (HIPAA, GDPR, SOC2) across all industrial solutions to protect sensitive data.
High-Performance Scaling
Our architectures are built to handle massive data loads and user bases, keeping performance steady whether you're serving ten or ten million.
Accelerated Time-to-Market
Using our suite of internal tools and proven frameworks, we reduce development cycles and get your product to market 40% faster.
Embedded AI Integration
Beyond simple wrappers, we build deep-learning integrations and predictive analytics directly into the core of your industry-specific workflows.
Engagement Model
How does a LIMS engagement work?
Timing depends on workflows and instruments. We agree a fixed first release on the scoping call.
01
Scoping call
We agree the lab type, the first workflow, the instruments and the controls that apply.
02
Lifecycle mapping
Sample states, handoffs and review rules mapped with bench staff and QA.
03
Fixed-scope first release
One workflow and one instrument in production, with weekly demos and an audit trail from day one.
04
Instruments and modules
Further interfaces, inventory and reporting added in the order the lab needs them.
05
Validation and support
Test evidence where the lab is regulated, then change control for every later release.
Facts and sources
Rules behind laboratory management software
Facts we design around, each linked to its primary source.
21 CFR Part 11 sets FDA's requirements for electronic records and electronic signatures, including secure, computer-generated audit trails.
Source: 21 CFR Part 11 (eCFR)21 CFR 11.10(e) requires secure, computer-generated, time-stamped audit trails that record the date and time of operator entries and actions that create, modify or delete electronic records, and record changes must not obscure previously recorded information.
Source: 21 CFR 11.10 (eCFR)21 CFR 211.194 requires laboratory records to include complete data derived from all tests necessary to assure compliance with established specifications, starting with a description of the sample received and its source.
Source: 21 CFR 211.194 (eCFR)21 CFR 211.68 requires that computers used in drug manufacturing have input and output checked for accuracy and that a backup file of entered data is maintained, secure from alteration, inadvertent erasure or loss.
Source: 21 CFR 211.68 (eCFR)
Voice of success
We don't just build products; we forge lasting partnerships. See how we've helped industry leaders transform their vision into technical reality.
“I can clearly see how Agnotic has a unique way of handling end-to-end development. They are always active on quick chat and provide support quickly.”
Aaron Phelan
Founder, Benchmark
“Agnotic combines deep technical expertise with strong domain knowledge. They understand the business context, anticipate challenges, and make collaboration smooth and effective.”
John Pasmore
Founder, Latimer
“Agnotic is the best technical team we evaluated. Their engineering excellence made our work dramatically easier and allowed us to stay focused on what matters most for maternal care outcomes. They took full ownership of the technical execution, and we are always happy to continue working together.”
Kim Smith
Founder, My Lauren
Related pages
Related lab and data pages
Pages that cover the work next to a LIMS build.
Laboratory information system development
The clinical LIS: EHR orders and results, LOINC and CLIA reporting.
Lab integration services
Connecting lab systems to EHRs and other clinical platforms.
Data engineering services
Pipelines and warehouses for instrument and result data.
QA and software testing services
Test scripts and evidence for validated lab systems.
Custom healthcare software development
Our main service page for custom healthcare builds.
More in Healthcare
More Healthcare Solutions
Explore other production-grade engineering platforms we deliver across healthcare.
Cross-Industry Reach
The Same Engineering Patterns, Across Other Industries
The technical patterns behind this platform translate naturally into adjacent verticals.
Frequently Asked Questions
It depends on the number of workflows, instruments and the controls the lab needs. We agree a fixed-scope first release on the scoping call and give you its timeline before work starts.
A LIMS manages samples, tests, instruments and inventory for research, QC and specialty labs. A laboratory information system manages patient orders and results for a clinical lab and exchanges them with an EHR. We build both, on separate pages, because the data model and the rules differ.
If the lab's records support an FDA-regulated activity, such as CGMP quality control, Part 11 applies to the electronic records and signatures. Research labs outside that scope may not need the full set, and we size the controls to the rule on the scoping call.
Yes. We connect through file exports, serial or network listeners or the vendor's API, depending on the instrument, and we record run metadata with each result so it can be traced back.
Yes, when the samples are linked to identifiable patients and the lab is a HIPAA covered entity or business associate. Many research and QC labs handle no PHI, and then a BAA is not needed.
Yes. Most LIMS engagements start with sample tracking for one workflow and one instrument in production, before inventory, reporting and more interfaces are added.
AI tools help our engineers draft code and tests, but a person reviews every change, and it passes the same automated tests, security checks and validation steps as any other code.
Industries