IVDR Sample Processing: 12% Faster in 6 Months
How a Vienna-based IVD manufacturer digitized production and quality control under IVDR and ISO 13485.
- Healthcare
- Biotech / IVD
- Compliance
- Industries
- Healthcare, Biotech/IVD
- Platform
- Web Application (LIMS)
- Delivery scope
- Legacy Replacement, Compliance, Digital Transformation
ABOUT THE PROJECT
Project overview
- Engagement
- 6 months
- Team size
- 7
- Core technologies
- React, .NET Core
- Regulatory frameworks
- EU IVDR, ISO 13485
Ingenetix GmbH is a Vienna-based diagnostics manufacturer (~24 people) developing real-time PCR test kits for pathogen detection in human medicine, veterinary medicine, and environmental testing.
To meet regulatory requirements for record-keeping and traceability, Ingenetix set out to fully digitize production and quality control — its previous tool was limited and lacked QC entirely. Limestone embedded a 7-person team to build Labigator New, a LIMS covering production, quality control, and traceability workflows.
Challenge
An unfinished tool, manual workflows, and a 10-year paper trail required by law.
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An unfinished predecessor
The first version of Labigator had far fewer features and its development was never completed. The quality control process was missing.
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Manual core workflows
Calculations, recipe tracking, and PCR instrument plate layout entry were still performed by hand.
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Traceability required by law
IVDR and ISO 13485 require complete traceability from raw materials through individual components to the end customer, with 10-year record retention.
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Error-prone instrument entry
Manual plate layout entry into PCR instruments took longer and was more prone to errors than an automated approach.
WHAT WE DID
Solution
Limestone's team took full ownership of delivery for 6 months, working from requirements through production deployment. The architecture uses React on the frontend with .NET Core services, role-based access controls, validation logic at each data entry point, and an audit trail built to meet ISO 13485 record-keeping requirements. The system retains all records for 10 years, matching Ingenetix's regulatory obligations under IVDR.
What the system does
Labigator New is a Laboratory Information Management System that digitizes Ingenetix's production and quality control workflows, replacing manual processes with automated, traceable operations across four core modules.
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Recipes & Formulations
Predefined components and concentrations for reagents, serums, and vaccines. Calculations and unit conversions are performed automatically, replacing manual math.
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Laboratory simulation
Select a product type, receive a full ingredient list with quantities and preparation instructions. The system shows possible results and flags missing components before lab work begins.
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Catalog & Raw Materials
Centralized management of raw materials with tracking from incoming materials through individual components to the finished diagnostic kit shipped to the customer.
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Quality Control & Reporting
QC run configuration with automated plate layout generation. The system exports a TXT file containing the PCR instrument's plate layout, which imports into the instrument without manual input. Audit trail and reporting built for ISO 13485 compliance.
Previously, the plate layout had to be entered manually into the PCR instrument. As the Ingenetix team noted, this "not only took longer, but was also more prone to errors." Labigator New now generates and exports the plate layout as a TXT file that imports into the instrument, removing the manual entry step.
Labigator New saves us a lot of time because the software automates many tasks that used to be performed manually.
Impact & Results
Labigator New went live after 6 months. Ingenetix achieved full regulatory traceability and measurable efficiency gains with their existing team.
- Full IVDR + ISO 13485 traceability achieved from raw materials through production to end customer.
- 10-year record retention built into the system, meeting regulatory obligations.
- Processing time reduced 12% across production and QC workflows.
- Daily lab procedure throughput increased 3% with existing staff, no additional headcount.
- Manual PCR plate layout entry replaced with automated TXT file export to instruments.
- Calculations automated through predefined recipes with built-in validation, reducing sources of error.
- Repeat engagement: Ingenetix chose Limestone again based on a prior positive experience.
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Reduction in processing time
12%
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Increase in daily lab throughput
3%
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IVDR-compliant record retention
10 yrs