OUR SERVICES · 06
Validation
Evidence that your systems perform as intended.
Plan and deliver qualification and validation around intended use, product risk and traceable evidence.
Discuss validation ↗Validation strategy & governance
Establish scope, system impact, responsibilities and a proportionate lifecycle approach.
- Validation master planning
- User requirements and risk assessments
- Traceability and change-control planning
Equipment & process validation
Connect requirements, qualification testing and process evidence in a documented lifecycle.
- Design, installation, operational and performance qualification
- Process validation and PPQ planning
- Protocol preparation, execution support and reporting
Cleaning & analytical validation
Define the rationale, test requirements and evidence needed for reliable cleaning and analytical activities.
- Cleaning-validation strategy and sampling
- Analytical method validation and transfer
- Acceptance criteria and evidence review
Computerised system validation
Assess intended use, data flows and GxP impact for systems such as LIMS, MES, ERP and quality platforms.
- Risk-based CSV planning
- Requirements, testing and traceability
- Electronic records, access and audit-trail review
Start with a defined scope
Deliverables and specialist involvement are agreed around your product, development stage, site and market. Contact us to confirm the right support for your programme.
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