Delivered in strategic cooperation with EY
In regulated life sciences environments, compliance is not optional. It is operational infrastructure.
As regulatory expectations from authorities such as FDA and EMA continue to evolve, pharmaceutical and biotech companies must ensure that their computerized systems, processes, and quality frameworks remain fully validated, traceable, and inspection-ready.
Together with EY, we deliver end-to-end GxP validation services that combine:
- Project governance and Computer System Validation (CSV) framework led by EY
- Deep GxP domain expertise and regulated industry know-how delivered by Virtux
This partnership ensures both strategic oversight and practical execution - from validation strategy to audit readiness.
GxP validation is not merely a regulatory obligation.
When executed correctly, it becomes a strategic advantage.
Strong validation frameworks:
- Reduce the risk of non-compliance and remediation costs
- Accelerate regulatory approvals and market access
- Increase transparency and audit confidence
- Strengthen operational efficiency
- Embed a sustainable culture of quality
We help transform compliance from reactive control into proactive governance.
Validation is not a one-time exercise. It is a continuous governance discipline.
We support ongoing optimization through:
- Lessons-learned integration
- Framework refinement
- Regulatory change adaptation
- Process standardization
Your validation framework evolves alongside regulatory expectations.
We design validation strategies aligned with your business objectives and regulatory landscape.
- Risk-based methodology in line with GAMP5 principles
- Clear validation roadmap and resource prioritization
- Alignment between IT, Quality, and Business functions
EY ensures structured governance and regulatory alignment.
Virtux ensures practical applicability within regulated GxP environments.
Lifecycle validation of computerized systems across regulated operations.
- User Requirements Specification (URS)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
All validation activities follow GAMP5 methodology and focus on intended use, data integrity, and system risk classification.
Regulators do not evaluate intent — they evaluate evidence.
We provide structured documentation support to ensure inspection readiness at any time:
- Validation plans and protocols
- Traceability matrices
- Summary reports
- SOP development and alignment
- Controlled documentation lifecycle management
Your validation documentation remains complete, consistent, and audit-ready.
Validated systems must remain validated.
We establish structured change control processes to manage system modifications without jeopardizing compliance.
- Impact assessments
- Risk re-evaluation
- Validation status tracking
- Controlled requalification where required
Compliance is preserved throughout the system lifecycle.
We simulate regulator expectations before regulators arrive.
- Internal compliance audits
- Gap identification
- Remediation planning
- Inspection readiness workshops
Our combined EY–Virtux expertise ensures both regulatory interpretation and operational practicality.
Compliance depends on people.
We deliver tailored training programs covering:
- GxP principles
- GAMP5 methodology
- Validation best practices
- Data integrity and quality culture
We enable teams to maintain validation standards independently.
Our cooperation with EY ensures:
- Structured project governance
- Independent validation oversight
- Alignment with global regulatory standards
- Scalable enterprise-grade delivery
Virtux contributes deep GxP and regulated-industry operational expertise, ensuring that validation frameworks are not only compliant — but practical and sustainable.
If your organization operates in GMP, GCP, or other regulated GxP environments, we help you build validation systems that are structured, defensible, and inspection-ready.
Our certified professionals bring extensive experience in deploying and managing solutions across diverse industries.
With a deep understanding of regulatory standards, we implement solutions that prioritize data protection and compliance.
From initial consultation through ongoing management, we provide comprehensive support to ensure the success of your initiatives.