Computer System Validation
Validation is more than meeting a requirement. It's about protecting, optimizing and scaling with confidence.
Beyond regulatory compliance
Validating a system means demonstrating that it works correctly, protects critical information and is under control when facing questions from health authorities.
At DRP Assurance we design validation processes that cover the entire documentary and functional life cycle of the system, from requirements born from user needs to system retirement, ensuring that every decision is supported and every risk is controlled.
Key Benefits
Critical data protection
We implement robust controls that guarantee integrity, availability and confidentiality of critical business information.
21 CFR Part 11 Compliance
We ensure full compliance with FDA regulations, including electronic signatures, audit trails and access controls.
Complete life cycle
We cover from requirements specification to system retirement, with traceable documentation at each phase.
Performance optimization
We identify opportunities for efficiency and performance improvements during the validation process.
Guaranteed scalability
We design validations that support future growth without compromising compliance or performance.
Audit support
We prepare documentation and evidence that withstand inspections from any international regulatory authority.
Our Process
Requirements analysis
We define functional, technical and regulatory requirements based on user needs and GAMP 5 standards.
Validation planning
We develop the validation master plan, defining strategies, resources, schedules and acceptance criteria.
Protocol execution
We execute IQ, OQ and PQ protocols with detailed documentation and objective evidence of each test performed.
Evaluation and reports
We analyze results, manage deviations and prepare validation reports with conclusions and recommendations.
Release and maintenance
We release the system for production and establish continuous monitoring and periodic revalidation programs.
Service Features
Methodology and Standards
- GAMP 5 based methodology
- 21 CFR Part 11 compliance
- ICH Q9 (QRM) alignment
- ISO 27001 integration
- FDA/EMA documentation
- Authority-validated templates
Deliverables and Documentation
- Validation Master Plan (VMP)
- URS/FRS/DDS specifications
- Executed IQ/OQ/PQ protocols
- Complete traceability matrix
- Final validation reports
- Operation and maintenance SOPs
Why choose DRP for CSV Validation?
Proven regulatory experience
We have successfully supported over 200 validations in FDA, ANVISA and other international authority inspections.
Comprehensive life cycle approach
We don't just validate, we ensure the system maintains its validated state throughout its entire operational life.
Updated technology and methodology
We use the latest GAMP versions, test automation tools and agile methodologies adapted to GxP.
Ready to validate with confidence?
Protect your technology investment and ensure regulatory compliance with validations that really work.
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