Validation Services
LabVantage validation services allow you to reduce the pain associated with the complicated process of validation. Our deep product knowledge and proven validation practices ensure you get a validated system that meets your quality and compliance expectations.
Risk-Based Approach Aligned with Industry Standards
Risk-Based Approach
Our validation methodology utilizes a risk-based approach as modeled in the GAMP 5 guidelines, tailoring tests and level of effort around technical, business, and regulatory risks. The approach is configurable to your preferences so that you can adjust the effort based on your quality and compliance needs.
| Probability | ||||
| Low | Medium | High | ||
| Severity | High | |||
| Medium | ||||
| Low | ||||
Severity = Impact on Patient Safety, Product Quality and Data Integrity (or other harm)
Probability = Likelihood of the fault occurring
Risk Class = Severity × Probability
| Detectability | ||||
| High | Medium | Low | ||
| Risk Class | 1 | |||
| 2 | ||||
| 3 | ||||
Detectability = Likelihood that the fault will be noted before harm occurs
Risk Priority = Risk Class × Detectability
Best Practices
Our validation methodology and deliverables are fully aligned with industry standards and best practices including the GAMP 5 guidelines and IEEE Standard 1012 System and Software Verification and Validation.
- GAMP 5
- GMP/GLP/GCP/GDocP
- 21 CFR Parts 11, 58, 210, 211, 820
- EU Annex 11
- ASTM Standard E2500
- ISO 13485, 15189, 17025
How we do it
Our validation services are designed to be highly flexible and scalable, ranging from an advisory level of support to providing a full turn-key validation. We start by making sure we have a complete understanding of your specific needs and only finish after ensuring these needs have been met through extensive testing and documentation.
Assessment
The initial assessment stage allows us to understand the level of complexity and your expectations. During this stage, we:
- Evaluate the project scope
- Review existing governance documentation
- Evaluate project documentation
- Gather information to understand your environment
Planning
During the planning stage, the definition of the project is determined, as well as the validation strategy. The Validation Master Plan is created, and Risk Assessments are conducted.
Verification and Testing
The verification stage involves test authoring and development of the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) scripts. We can also help with protocol execution, test result review, and approval.
Documentation
This stage involves the creation and management of the traceability matrix, deviation management and resolution, validation summary reports and user manual creation, and training delivery.