LIMS Validation Services
Ensure LIMS compliance and data integrity with LabVantage validation services
Count on our validation like you count on your LIMS
Regulated industries require validation of LIMS. To ensure your LIMS remains in compliance with regulations, it is essential that the delivered software is properly validated.
Your LIMS brings everything together, from the laboratory workflows, data compliance, instrument integration, and communication, to data generation, collection, analysis, reporting, and delivery. As LIMS have become more prominent, however, compliance and validation have grown increasingly complex.
LabVantage Validation Services simplifies this complicated process for you. Our deep product knowledge, proven practices, and risk-based approach ensure that your LIMS meets all quality and compliance expectations—both yours and those of your regulators.
4 LIMS validation phases:
- Assessment – to evaluate project scope, review existing governance documentation, and understand your environment.
- Planning – define project and validation strategy, create Validation Master Plan, and conduct risk assessments.
- Verification and Testing – Develop installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) scripts; assist with protocol execution, test result review, and approval.
- Documentation – Create and manage traceability matrix, deviation management and resolution, validation summary reports and user manuals, and training delivery.
Find out how LabVantage Validation Services can make LIMS compliance easier for your team, so you can focus on what you do best.
Ensure the validation of your LIMS deployment with expert services from LabVantage.
Save time, resources, and frustration in LIMS validation
Flexible and scalable
LabVantage Validation Services are designed to be highly flexible and scalable, ranging from an advisory level of support to providing a full turn-key validation.
Aligned with industry standards and best practices
LabVantage validation methodology and deliverables are aligned with a broad range of industry standards and best practices, including GAMP 5 guidelines and IEEE Standard 1012 System and Software Verification and Validation. Industry standards include: GxP; 21 CFR parts 11, 58, 210, 211, and 820; EU Annex 11; ASTM Standard E2500; and ISO 13485, 15189, and 17025.
Risk-Based Approach
Our validation methodology’s risk-based approach is modeled on the GAMP 5 guidelines, tailoring tests and level of effort around technical, business, and regulatory risks. The approach is configurable to your quality and compliance needs.
Vendor testing is not enough
Although commercial LIMS vendors perform initial internal system testing, more is required. The system needs to be validated in your intended operating environment, using your own products.
