LIMS Validation Services
Professional validation of your LIMS using automation testing and Computer Software Assurance (CSA) or Computer System Validation (CSV)
Ensure LIMS compliance and data integrity with LabVantage validation services
In regulated industries, where Laboratory Information Management System (LIMS) validation is required, LabVantage Validation Services eliminate the complexity and effort of validating intricate implementations. Our expert-led, automated, and risk-based approach streamlines the validation process, replacing the traditional in-house testing typically performed by customers as part of their acceptance process.
Save time, reduce costs, and minimize errors with LabVantage. We simplify and accelerate validation, ensuring a faster, more precise, audit-ready, and fully compliant LIMS implementation.
Why Choose LabVantage for Validation?
Conducting in-house validation demands substantial resources, including time, skilled personnel, and specialized expertise. By leveraging LabVantage’s professional Validation Services, customers benefit from:
Expertise in the Native Application
As the developers and maintainers of LabVantage LIMS, our team has the deepest understanding of its functionality, architecture, and compliance requirements. No third-party vendor or internal IT team can match our proficiency in ensuring accurate and efficient validation.
Efficiency Through Automation
LabVantage utilizes automated testing solutions to significantly reduce validation timelines while maintaining accuracy and thoroughness. This automation accelerates test execution and minimizes manual effort, allowing for faster system deployment.
Regulatory Compliance
Our validation services align with global regulatory requirements, covering North America, Europe, APAC, and South America. We ensure that customers remain compliant with evolving industry standards while reducing the risk of validation gaps. With deep expertise in LabVantage LIMS, automated testing, FDA 21 CFR Part 11, EU Annex 11, GxP, and GAMP 5 standards, and a proven track record in GxP-regulated industries, we eliminate the complexity of manual validation.
Reduced Operational Burden
By outsourcing validation to LabVantage, laboratories can free internal resources to focus on scientific and operational priorities rather than navigating complex validation procedures.
Optimal LIMS Validation: Leveraging CSA or CSV Approaches
The US FDA – looking to reduce cost and timelines of validation – has begun issuing guidance on a risk-based approach to validation known as Computer Software Assurance (CSA). LabVantage Validation Services embraces CSA principles, which focus on critical aspects of software functionality that impact patient safety, product quality, and data integrity.
Advantages of CSA:
- Reduces unnecessary documentation, allowing for more efficient, risk-based validation efforts.
- Encourages the use of unscripted and automated testing, increasing agility while maintaining compliance.
- Supports continuous validation, aligning with modern DevOps and Agile software development practices.
Advantages of CSV:
- By using predefined specifications, CSV provides uniformity in the validation process.
- Increases the accuracy and traceability of the system by providing rigorous documentation and reporting.
- Boost efficiency and productivity by reducing manual errors, bottlenecks, and repetitive tasks.
Automated Testing in CSA or CSV Implementation
With dedicated LabVantage professionals serving you, you’ll have:
✔ Faster, more efficient validation cycles
✔ Greater test accuracy and repeatability
✔ Lower validation costs and reduced manual effort
✔ Enhanced compliance with robust audit trails
✔ Scalability to support ongoing system upgrades and patches
