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New HDLIMS Assistant: governed AI for regulated labs

Lab data in high definition

HDLIMS unifies LIMS, ELN, lab execution and scientific data management on one cloud-native platform, so regulated labs release faster, stay inspection-ready and adapt without custom code.

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  • Part 11 & Annex 11 controls
  • Cloud, private cloud or on-prem
  • Validation package included

Designed to support compliance with

  • 21 CFR Part 11
  • EU GMP Annex 11
  • GAMP 5
  • ISO/IEC 17025
  • ISO 15189
  • GLP
  • ALCOA+
  • HIPAA
  • GDPR

One platform

Every lab workflow on a single data model

Most labs stitch together a LIMS, an ELN, paper worksheets and file shares, then spend years maintaining the interfaces. HDLIMS replaces the patchwork with one platform where every sample, result, instrument file and quality event is connected.

  • Applications share master data, permissions and audit trail
  • Add modules as you grow, without new integrations
  • Open APIs for instruments, ERP, MES and data platforms
Platform overview

Applications

LIMS Samples & results ELN Experiments LES Method execution SDMS Raw data

Modules

Quality & Compliance Stability Environmental Monitoring Inventory & Resources Analytics & AI

HDLIMS Foundation

Unified data modelNo-code workflow engineAudit trail & e-signaturesIdentity & accessAPIs & integration hub
HDLIMS Cloud Private cloud On-premises Instruments · ERP · MES · QMS

Why labs switch to HDLIMS

Built for how modern labs actually work

Legacy LIMS were designed for a different era of IT. HDLIMS was designed for configurability, compliance and connected data from the first line of code.

Adapt the system in days, not development cycles

Sample types, workflows, specifications, calculations and reports are configured in visual tools. Configuration is versioned and promoted like software, so change control is simple and upgrades never break your lab.

  • Visual workflow and method designers for lab administrators
  • Configuration packages promoted from test to production
  • Upgrades that carry your configuration forward, with no custom code to re-test
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Data integrity built into every record

Audit trails are always on, electronic signatures are bound to their records, and workflows enforce the SOP as it is executed. ALCOA+ is a property of the system, not a training slide.

  • Controls designed to support 21 CFR Part 11 and EU GMP Annex 11
  • Risk-based audit trail review queues
  • Validation accelerator package with every release
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Instrument data that never needs re-typing

Balances, titrators, chromatography data systems and plate readers deliver results directly into the record, with the raw data preserved and linked. Transcription errors and second-person checks of typed values disappear.

  • Direct capture from bench instruments during guided execution
  • Automated raw data capture and parsing with the HDLIMS SDMS
  • Every value stamped with instrument, calibration status and analyst
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See trends before they become deviations

One data model means analytics run on live data. Operational dashboards show backlog and turnaround as they are, and statistical trending flags drift long before an annual review.

  • Operational dashboards by lab, method and customer
  • Control charts with configurable run rules
  • A governed AI assistant that cites the records it uses
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Sample lifecycle

From sample to decision, fully traceable

Every step is attributable, time-stamped and linked to the steps before it, so you can reconstruct the complete history of any result in seconds.

  1. 01

    Register

    Samples created from ERP, portal or bench, labeled and assigned the right tests.

  2. 02

    Receive

    Condition, custody and storage location captured on receipt.

  3. 03

    Test

    Guided execution with live instrument capture and limit checks.

  4. 04

    Review

    Review by exception surfaces only what needs human judgment.

  5. 05

    Approve

    Part 11 e-signatures with defined meaning, bound to the record.

  6. 06

    Report

    CoAs and reports generated from approved data, sent automatically.

Always-on audit trail Electronic signatures ALCOA+ by design Linked raw data

Solutions

Purpose-built for regulated industries

Pre-configured workflows, terminology and reports for the way your industry tests, reviews and reports.

All solutions

Pharmaceutical QC

GMP quality control from raw material receipt to batch release, with Part 11 controls throughout.

Explore

Biotech & Biologics

One connected record from cell line and process development through tech transfer and GMP release.

Explore

Clinical & Diagnostics

Accessioning, specimen tracking and reporting for CLIA, CAP and ISO 15189 labs, from routine to genomic testing.

Explore

Biobanking

Consent-aware sample management from collection and processing to storage, aliquoting and distribution.

Explore

Food & Beverage

Micro and chemistry testing, positive release, supplier CoAs and shelf-life studies at plant and central labs.

Explore

Environmental Testing

Chain of custody, holding times, QC batches and EDDs for TNI and ISO/IEC 17025 accredited environmental labs.

Explore

Chemicals & Materials

Plant and process lab testing with grade specs, shift schedules, SPC and automated CoAs, linked to historian and ERP.

Explore

Contract Testing Labs

Quotes, client portal, study management, TAT tracking and invoicing, with each client’s data kept strictly separate.

Explore

Modern vs. legacy

The LIMS replacement your IT and QA teams can both agree on

If your current system needs consultants for every change and a multi-year project for every upgrade, it is costing more than its license fee.

Why HDLIMS Plan a migration
Legacy LIMS HDLIMS
Architecture Client-server roots, cloud as an afterthought Cloud-native, API-first, one data model
Changing workflows Custom code and vendor services No-code configuration by lab admins
Upgrades Multi-year projects with full re-validation Regular releases with configuration carried forward
LIMS, ELN, LES, SDMS Separate products and integrations One platform, shared records
Validation Built from scratch by each customer Vendor validation package included
User experience Dense forms built for power users Modern, bench-ready interface on any device

Deployment & security

Your data, your choice of deployment

The same HDLIMS platform runs as a managed service, in a dedicated private cloud, or in your own data center, with enterprise security in every model.

HDLIMS Cloud

Fully managed SaaS with continuous updates, monitoring, backups and regional data residency options. The fastest path to value.

Private cloud

A dedicated, single-tenant environment managed by HDLIMS, with your own release cadence and network isolation.

On-premises

Install HDLIMS in your own data center or private cloud account, with full control of infrastructure and upgrades.

Encryption in transit and at rest SSO with SAML 2.0 and OpenID Connect Granular role-based access Regional data residency Security & trust

Implementation

Live in phases, validated from day one

Our implementation methodology is designed for regulated labs: start focused, validate as you go, and expand with confidence.

  1. 1

    Discover

    Map workflows, data and integrations; agree scope, risks and a phased roadmap.

  2. 2

    Configure

    Configure HDLIMS from industry templates in short iterations with your subject matter experts.

  3. 3

    Validate

    Risk-based validation that builds on our vendor package, aligned with GAMP 5 and CSA.

  4. 4

    Go live and expand

    Hypercare, training and adoption metrics, then the next lab, site or module.

Included with every project

  • Industry-specific configuration templates
  • Validation accelerator package (risk assessment, traceability, test scripts)
  • Data migration from legacy LIMS, spreadsheets and paper
  • Role-based training and a train-the-trainer program
  • A named customer success manager
Our services

Resources

Guides for lab and quality leaders

Practical, vendor-neutral guidance on selecting, validating and getting value from lab informatics.

All resources
Compliance 11 min read

21 CFR Part 11 Checklist for LIMS: What Your System Must Do

A practical 21 CFR Part 11 checklist for LIMS: scope, closed vs. open systems, every Subpart B and C control, and what to verify in your system.

Read article
Guide 11 min read

LIMS Buyer's Guide 2026: How to Evaluate and Select a Laboratory Information Management System

A vendor-neutral guide to choosing a LIMS in 2026: requirements, deployment models, validation, integration, total cost of ownership and a scoring matrix.

Read article
Compliance 8 min read

Data Integrity and ALCOA+ in the QC Laboratory

What ALCOA and ALCOA+ mean for QC lab records, the data integrity failures inspectors cite most, and how system design and audit trail review prevent them.

Read article

FAQ

Frequently asked questions

Can’t find what you are looking for? Our team is happy to help.

Contact us
What is HDLIMS?
HDLIMS is a laboratory informatics platform that combines a LIMS, electronic lab notebook (ELN), lab execution system (LES) and scientific data management system (SDMS) on one cloud-native foundation, with quality, stability, environmental monitoring, inventory and analytics modules.
Which laboratories use HDLIMS?
HDLIMS is built for regulated and quality-critical labs: pharmaceutical and biotech QC and R&D, clinical and diagnostic labs, biobanks, food and beverage, environmental testing, chemicals and materials, and contract testing labs. See Solutions.
Does HDLIMS support 21 CFR Part 11 and EU GMP Annex 11?
Yes. HDLIMS provides the technical controls these regulations require, including secure audit trails, electronic signatures bound to records, access controls and record retention, plus a validation package to support your computerized system validation. See Compliance.
How does HDLIMS compare with established LIMS vendors?
Platforms such as STARLIMS, LabWare, LabVantage and Thermo Fisher SampleManager are mature and widely deployed. HDLIMS takes a different architectural approach: cloud-native, a single data model across LIMS, ELN, LES and SDMS, and no-code configuration in place of custom code. We encourage every buyer to compare vendors with scripted demos of their own workflows. See Why HDLIMS.
Can HDLIMS be deployed on-premises?
Yes. HDLIMS is available as a fully managed cloud service, in a dedicated private cloud, or installed in your own data center. The functionality is the same across deployment models.
How long does an HDLIMS implementation take?
Timelines depend on scope, sites and integrations. We deliver in phases, starting with a focused first go-live and expanding lab by lab. Your project plan is agreed during discovery. See Services.

See HDLIMS running your workflows

Book a tailored demo with a lab informatics specialist. We map your sample types, methods and compliance requirements, then show you exactly how HDLIMS fits.

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