Digital lab processes that stand up to every regulatory inspection
LIMS & Digital Lab Processes
Laboratory information management systems (LIMS) and digital lab workflows — for pharma, life sciences and research institutions.
Anonymized reference casePharmaceutical quality control laboratory · Frankfurt, 45 employees+
Starting point
Paper-based sample intake, manual data entry from analytical instruments, lack of traceability, FDA audit risk.
Solution & result
LIMS implementation with full instrument integration (HPLC, GC, spectrometers), electronic audit trail and GxP validation according to GAMP 5.
FDA audit passed successfully, sample turnaround time reduced by 40%, 0 manual transfer errors, ISO 17025 accreditation renewed.
Paper-based lab processes are a compliance risk
- Manual data entry from analytical instruments: every transfer is a potential source of error and a gap in the audit trail
- Authorities (FDA, EMA, accreditation bodies) expect complete electronic evidence of all lab activities — paper documentation is no longer considered sufficient
- Excel-based results documentation does not meet the requirements of 21 CFR Part 11 (electronic records)
A fully digital lab — validated, auditable, GxP-compliant
- Automatic data capture from analytical instruments eliminates manual entry and closes every gap in the audit trail
- GxP validation according to GAMP 5 with complete DQ/IQ/OQ/PQ documents — compliant with regulatory requirements and reproducible
- We have worked on lab processes in pharma, life sciences and research — we understand the regulatory requirements from hands-on experience
Scope of services
What Laboratory Solutions does for you
LIMS Implementation
Rollout and configuration of laboratory information management systems in line with GxP requirements.
Instrument Integration
Automatic data capture from laboratory instruments and analytical devices.
Sample Management
Complete digital tracking of every sample from receipt to archiving.
Reporting & Analysis
Automated reports, quality control charts and regulatory documentation.
Validation
GxP-compliant system validation according to GAMP 5 for pharmaceutical and regulated environments.
Audit Trail
Complete electronic audit trail for all data entries and system changes.
Approach
How we work
Requirements Analysis
Documentation of all lab 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 your existing IT landscape.
Validation & Go-Live
GxP validation, training of lab staff and supported launch.
The FDA audit was the test. Thanks to the complete electronic audit trail and the GAMP 5 validation documentation, we passed without a single finding. That would have been unthinkable with our old paper system.
LIMS Modules
Every lab process digital —
no more paper documents
A complete LIMS digitizes all laboratory processes, from sample receipt to result release — fully auditable, GxP-compliant, ISO 17025-ready.
Full traceability of every sample: receipt, analysis, result, archiving — with a complete audit trail.
Automatic data capture from HPLC, GC, spectrometers, balances and specialized instruments — no manual entry.
Statistical evaluation, QC charts, out-of-specification management and automated 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.
Complete record of all data entries, changes and approvals — compliant with regulatory requirements.
Validated per
GAMP5
GAMP5 Validation
A complete validation package — no gaps
We deliver the full validation package according to GAMP5 — the FDA, EMA and accreditation bodies accept our documentation.
Design Qualification
Evidence that the system design meets the user requirements (URS).
Installation Qualification
Evidence of correct installation and configuration according to specification.
Operational Qualification
Evidence that the system works as specified — all test cases documented.
Performance Qualification
Evidence of reliable operation in routine use under real-world conditions.
We speak the language of regulated environments
Our LIMS consultants have hands-on lab experience in pharma, life sciences and research. We know GLP, GCP, GMP, ISO 17025 and 21 CFR Part 11 from practice — not just from the textbook. That makes the difference during 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 on vendor preference.
02What is GAMP 5 validation and do I need it?+
GAMP 5 (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 connected?+
We integrate all common laboratory instruments via vendor-standard APIs and proprietary protocols: HPLC, GC, spectrometers, balances, pH meters, microscopes and specialized equipment. Instrument integration is a core competency of our lab solution — manual data entry is eliminated.
04How long does a LIMS implementation take?+
Standard LIMS without GxP validation: 8–14 weeks. With full GAMP 5 validation: 16–24 weeks. Validation projects cannot be accelerated without compromising quality — we plan realistically and stick to the schedule.
05What does a LIMS implementation cost?+
Depending on the system and scope: standard LIMS from €40,000, with GxP validation from €80,000. Custom solutions for special requirements on request. Free analysis workshop to determine your needs.
06Does the LIMS meet the requirements of 21 CFR Part 11?+
Yes. Our LIMS implementations meet the 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 obligation
In 60 minutes, we analyze your current situation and show you exactly which solution makes sense for your business — with a binding quote within 5 business days.