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Validation Services

LabVantage validation services allow you to reduce the pain associated with the complicated process of validation. Our deep knowledge of the product and good validation practices will help ensure that you have a validated system that can meet 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 GAMP 5, 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 GAMP 5 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 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 finish after ensuring these needs were 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 and 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.