Digital laboratory processes that withstand any regulatory inspection
LIMS & digital laboratory processes
Laboratory Information Management Systems (LIMS) and digital laboratory workflows — for pharma, life sciences, and research institutions.
Anonymized Reference CasePharmaceutical control laboratory · Frankfurt, 45 employees+
Initial Situation
Paper-based sample receipt, manual data entry from analytical instruments, missing traceability, FDA audit risk.
Solution & Result
LIMS implementation with complete instrument integration (HPLC, GC, spectrometer), electronic audit trail, and GxP validation per GAMP5.
FDA audit passed successfully, sample throughput time reduced by 40%, 0 manual transfer errors, ISO 17025 accreditation renewed.
Paper-based laboratory processes are a compliance risk
- Manual data entry from analytical instruments: every transfer is a potential error source and a gap in the audit trail
- Regulators (FDA, EMA, accreditation bodies) expect complete electronic evidence of all laboratory activities — paper documentation is no longer considered sufficient
- Excel-based results documentation does not meet the requirements of 21 CFR Part 11 (electronic records)
Fully digital laboratory — validated, auditable, GxP-compliant
- Automatic data acquisition from analytical instruments eliminates manual entry and closes the audit trail completely
- GxP validation per GAMP5 with complete DQ/IQ/OQ/PQ documents — regulatory-compliant and reproducible
- We know laboratory processes in pharma, life sciences, and research — we understand the regulatory requirements from practice
Scope of Services
What Laboratory Solutions does for you
LIMS Implementation
Introduction and configuration of Laboratory Information Management Systems per GxP requirements.
Instrument Integration
Automatic data acquisition from laboratory instruments and analytical devices.
Sample Management
Complete digital tracking of all samples from receipt to archiving.
Reporting & Analysis
Automated reports, quality control charts, and regulatory documentation.
Validation
GxP-compliant system validation per GAMP5 for pharmaceutical and regulated environments.
Audit Trail
Complete electronic audit trail for all data entries and system changes.
Our Approach
How we work
Requirements Analysis
Capture of all laboratory processes, regulatory requirements, and integration points.
LIMS Selection & Design
Technology selection and system design tailored to your processes and compliance requirements.
Implementation
Configuration, development of customizations, and integration into the existing IT landscape.
Validation & Go-Live
GxP validation, training of laboratory staff, and accompanied launch.
The FDA audit was the test. Thanks to the complete electronic audit trail and GAMP5 validation documentation we passed without a single finding. That would have been unthinkable with our old paper system.
LIMS Modules
All laboratory processes digital —
no more paper documents
A complete LIMS digitalizes all laboratory processes from sample intake to result release — fully auditable, GxP-compliant, ISO-17025-ready.
Complete traceability of all samples: intake, analysis, result, archiving — seamless audit trail.
Automatic data capture from HPLC, GC, spectrometers, balances and specialized instruments — no manual entry.
Statistical evaluation, QC charts, out-of-spec management and automatic reporting.
Version control for SOPs, work instructions and method descriptions — always the current version.
21 CFR Part 11-compliant electronic signatures for release processes — audit-proof.
Seamless proof of all data entries, changes and approvals — authority-compliant.
Validated per
GAMP5
GAMP5 Validation
Complete validation package — no gaps
We deliver the complete validation package per GAMP5 — FDA, EMA and accrediting bodies accept our documentation.
Design Qualification
Proof that the system design meets user requirements (URS).
Installation Qualification
Proof of correct installation and configuration per specification.
Operational Qualification
Proof that the system functions as specified — all test cases documented.
Performance Qualification
Proof of reliable operation in routine use under real conditions.
We speak the language of regulated environments
Our LIMS consultants have laboratory experience in pharma, life sciences and research. We know GLP, GCP, GMP, ISO 17025 and 21 CFR Part 11 from practice — not just from textbooks. That makes the difference in regulatory inspections.
Frequently Asked Questions
Everything you need to know about Laboratory Solutions at a glance.
01Which LIMS systems do you implement?+
We implement leading systems such as LabWare, STARLIMS, LabVantage, and Qualtrax. For specific requirements we also develop custom LIMS solutions. System selection is based on your processes, budget, and regulatory requirements — not vendor preference.
02What is GAMP5 validation and do I need it?+
GAMP5 (Good Automated Manufacturing Practice) is the industry standard for validating computerized systems in regulated environments. If you work under GxP (GLP, GCP, GMP) or are ISO 17025 accredited: yes, you need it. We create the complete validation package (VP, DQ, IQ, OQ, PQ).
03Which analytical instruments can be integrated?+
We integrate all common laboratory instruments via manufacturer-standard APIs and proprietary protocols: HPLC, GC, spectrometer, balances, pH meters, microscopes, and specialist equipment. Instrument integration is a core competence of our laboratory solution — manual data entry is eliminated.
04How long does a LIMS implementation take?+
Standard LIMS without GxP validation: 8–14 weeks. With full GAMP5 validation: 16–24 weeks. Validation projects cannot be accelerated without compromising quality — we plan realistically and keep to the schedule.
05What does a LIMS implementation cost?+
Depending on system and scope: standard LIMS from €40,000, with GxP validation from €80,000. Custom solutions for specific requirements on request. Free analysis workshop for needs assessment.
06Does the LIMS meet 21 CFR Part 11 requirements?+
Yes. Our LIMS implementations meet FDA requirements for electronic records and signatures (21 CFR Part 11): electronic audit trail, access control, electronic signatures, and data integrity. All regulatory requirements are documented in the validation plan.
Free Assessment Workshop — no commitment
In 60 minutes we analyze your current situation and show you concretely which solution makes sense for your business — with a binding offer within 5 business days.