Validation of Laboratory Information and Management Systems (Lab IT)
- GxP and IT Expertise from a Single Source
- 30+ Years of Experience in Regulated Industries
- SAP Silver Partner
Validation of Laboratory Systems (Lab IT)
Laboratory systems are the backbone of regulated quality and development processes. They manage inspection results, stability programs, raw data analyses, releases and regulatory documentation. At the same time, system complexity and integration levels are growing – from LIMS through CDS and ELN to ERP connections.
With this digitalization, regulatory requirements are also increasing. Data integrity (ALCOA+), Annex 11, 21 CFR Part 11, ISO 17025 and ISO 13485 require structured validation and permanent control of the valid state.
For management, QA and IT leadership, central questions arise:
- How can complex Lab IT landscapes be operated in a regulatory-compliant manner?
- How does Lab IT remain permanently validated even with system updates and method adjustments?
- How can inspection risks and remediation costs be avoided?
DHC supports you in setting up your Lab IT landscape in a regulatory-compliant, architecturally stable and long-term audit-ready manner.
Challenges in the Validation of Laboratory Systems
Complex System Landscape
Historically grown LIMS, CDS and equipment systems increase integration and validation complexity.
Data Integrity / Audit Trail
Audit trails, raw data and signatures are the focus of regulatory inspections.
Lifecycle & Change Dynamics
System updates and method changes jeopardize the permanently valid state.
Comprehensive Lab IT Validation
Sustainable validation of laboratory systems goes beyond test documents. What matters is an integrated governance and lifecycle model that structurally connects system architecture, laboratory processes, regulatory requirements and data integrity.
DHC develops a risk-based validation concept for your entire Lab IT landscape with you – from LIMS and CDS to integration with ERP and QMS systems. Based on GAMP 5, we establish clear risk analyses, robust test strategies, structured documentation and defined periodic review processes. Data integrity principles according to ALCOA+ are systematically integrated into your processes.
Typical System Landscape in a Regulated Testing Laboratory
The real challenge for software validation lies less in the individual system, but rather in the integration, data consistency and regulatory manageability of the entire architecture. Because laboratories often contain a combination of the following systems:
- Enterprise Resource Planning System (ERP)
- Laboratory Information Management System (LIMS)
- Laboratory Execution System (LES)
- Chromatography Data System (CDS)
- Laboratory Equipment (DEV)
- Monitoring System (MON)
- Scientific Data Management System (SDMS)
- Electronic Lab Notebook (ELN)
The systems listed represent only a selection of our validation expertise.
If your solution to be validated is not listed here, please contact us.
Digital Transformation in the Laboratory and IT Compliance
DHC Consulting Services
Compliance Check & Strategy
Transparency about your Lab IT compliance and validation landscape.
- Lab IT compliance analysis
- Data integrity assessments
- Assessment of existing validation frameworks
- Inspection readiness checks
- Development of risk-based validation strategies
Laboratory System Validation
Operational validation of complex laboratory systems.
- Validation of LIMS, CDS, ELN and analytical software
- Development of validation strategy, plan and report
- Requirement management and test design
- Audit trail and data integrity assessments
- Inspection support
Lab IT Services & Support
Ensuring a permanently valid system state.
- Periodic Reviews
- Change Impact Analyses
- Remediation Programs
- Managed Validation Services
Why DHC – Your Specialist for Lab IT Validation
DHC combines regulatory compliance expertise with deep understanding of laboratory processes and IT architectures.
For over 30 years, we have been supporting life sciences companies in validating complex computerized systems.
Our clients benefit from:
- A proven risk-based DHC validation methodology
- Digital validation solutions such as the DHC Smart Validation Accelerator
- High audit and inspection security
Our goal is not just a successful inspection – but a permanently stable and economically manageable Lab IT architecture.
Validation of Laboratory Systems
Trust through Experience
We are the specialist for GxP Compliance.
“Due to their over 20 years of experience in IT Compliance, highly refined validation concepts for SAP and ready-made documentation, we chose DHC as our validation partner. On November 13, 2019, we passed a 4-day FDA inspection without any findings in the SAP area and received the GMP certificate. There were no deviations or comments regarding qualification and validation.”
“The collaboration with DHC was always goal-oriented and very pleasant. Thanks to the high expertise in GMP and CSV as well as the development of a suitable risk management and framework, Hamilton Bonaduz AG was able to become the first Swiss life science company to achieve successful validation completion for Microsoft Dynamics D365FO in Switzerland.”
Frequently Asked Questions about Validation of Laboratory Systems
When does a laboratory system require validation?
As soon as it generates, processes or stores GxP-relevant data and has an impact on product quality, patient safety or regulatory documentation.
What risks arise from insufficient lab IT validation?
Possible consequences include inspection findings, warning letters, batch delays, data integrity complaints and reputational damage.
How do you integrate laboratory systems in a structured manner into an existing QMS?
Through clear governance regulations, defined lifecycle processes, documented risk analyses and a harmonized SOP structure.
When does retrospective validation make sense?
For historically grown systems without complete documentation or in preparation for regulatory inspections.
How does structured lab IT validation affect total cost of ownership?
A clearly defined validation and lifecycle model reduces remediation effort, audit risks and unplanned re-validations and creates long-term cost transparency.
Validation of Laboratory Systems