Expertise 02
Quality Management & Validation
Systems, methods and principles that ensure quality, data integrity and validation. Quality systems and validated computerised systems are the foundation of trust in regulated operations. VITA supports risk-based approaches — from QMS design to Computer System Validation (CSV) and Computer Software Assurance (CSA) — aligned with GAMP 5 principles.
Services
- Quality Management Systems (QMS)
- Computer System Validation (CSV)
- Computer Software Assurance (CSA)
- GAMP 5
- Risk-Based Validation
- Quality Risk Management
- ALCOA+ – Data Integrity Principles
- Qualification & Validation
- SOPs, procedures and documentation
- Audit trails and electronic signatures
- Change Control and Deviation Management
- QMS maturity assessment
- Deviation, CAPA & change control optimisation
- SOP governance & Quality Manual
- Supplier qualification & oversight
- GMP & GDocP training
Typical challenges
- Validation effort that is disproportionate to system risk
- Transitioning from traditional CSV to a CSA mindset
- Maintaining data integrity (ALCOA+) across hybrid system landscapes
- Validating cloud, SaaS and continuously updated systems
How VITA can support
- Validation strategies and master plans based on critical thinking and risk
- QMS design, harmonisation and process improvement
- Supplier and system risk assessments
- Audit and inspection readiness for computerised systems
Related expertise
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