Validation services for Pharma and MedTech
Risk-based validation support across computer systems, equipment, process validation, data integrity and inspection readiness.
Supporting regulated Life Sciences manufacturers.
Aligned to GAMP 5, FDA 21 CFR Part 11 and EU Annex 11.
Onsite, remote, project-based or embedded team support.
Validation services built for regulated Manufacturing
We help Pharma and MedTech teams validate systems, equipment and processes with a practical, risk-based approach that supports compliance, efficiency and audit readiness.
Computer Software Assurance (CSA)
Modern, risk-based assurance aligned with CSA principles, focused on critical functions, meaningful testing, and reduced documentation overhead.
- Risk-based testing strategy
- Critical thinking approach
- Faster validation cycles
- Suitable for LMS, MES, ERP and supporting systems
👉 → Explore how CSA supports AI-enabled validation (link blog 2 here)
Computer System Validation (CSV)
End-to-end validation support for computerised systems operating in GMP environments.
- Lifecycle-aligned validation
- Part 11 and Annex 11 support
- MES, ERP, automation and digital systems
- Audit-ready documentation and governance
- Risk-based validation aligned with GAMP 5
👉 → Learn more about risk-based CSV for modern systems (link blog 1 here)
Data Integrity & Governance
Structured frameworks to strengthen digital record control, data lifecycle visibility and cross-functional accountability.
- System inventory and criticality assessment
- Data flow and lifecycle mapping
- Gap analysis and remediation planning
- Governance framework development
Equipment & Process Validation
Practical validation support for manufacturing operations, aligned to quality, engineering and operational goals.
- Equipment qualification support
- Process validation delivery
- Cross-functional stakeholder coordination
- Scalable onsite or remote resource support
Modern Approaches to Computer System Validation
As computerized systems evolve to include AI-enabled functionality and cloud-based platforms, validation approaches must also adapt. Risk-based validation aligned with GAMP 5, CSA principles, and Annex 11 Clause 5 helps ensure systems remain compliant, efficient, and inspection-ready.
Assess your current CSV or CSA strategy against Annex 11, GAMP 5, and emerging AI requirements.
Why Dataworks
We work across Quality, Engineering, IT, Automation and Manufacturing to deliver validation programmes that are compliant, efficient and understandable to both technical and non-technical stakeholders.
Whether you need embedded engineers, project support or specialist guidance, our team integrates with your operation and helps maintain momentum without compromising compliance.
Validation activity aligned to regulatory expectations and real operational risk.
Support for short-term projects, programme delivery or long-term embedded assignments.
Reduce documentation burden, focus effort on critical risk and accelerate validation outcomes.
How we work with you
A straightforward model designed to create clarity, reduce risk and keep validation programmes moving.
Assess
Understand your systems, risks, compliance gaps and operational priorities.
Design
Build a right-sized validation strategy, governance model and delivery plan.
Deliver
Execute validation efficiently with embedded expertise, protocols and testing support.
Sustain
Strengthen long-term compliance through governance, data integrity and continuous improvement.
Need validation support for a GMP-critical system or programme?
Speak to Dataworks about CSA, CSV, data integrity, process validation and inspection-readiness support tailored to your operation.