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What You Get (Validation Deliverables)
Core CSV package (audit-ready):
- •Validation Plan (VP) + Validation Summary Report (VSR)
- •User Requirements Specification (URS)
- •Functional/Configuration Specifications (FRS/FS)
- •Risk Assessment (GxP impact + controls)
- •Traceability Matrix (RTM) from requirements → tests → evidence
- •Test Protocols & Evidence (IQ/OQ/PQ where applicable)
- •SOP set (Change Control, Incident/Deviation, Access Control, Backup/Restore)
- •Periodic Review template + revalidation triggers
Key Features of TechyPharma CSV Approach
Our comprehensive approach ensures compliance while maintaining operational efficiency
Risk-Based Validation (Fast, Focused, Defensible)
- Validate what matters most: patient safety, product quality, and data integrity
- Scale documentation based on system impact and complexity
- Clear responsibilities: client vs vendor vs hosting providers
Built for SaaS & Cloud Systems
- Validation for configured platforms, not just custom code
- Evidence for hosting controls (security, backups, DR, monitoring)
- Release validation support for frequent updates
"Always-On" Inspection Readiness
- Traceability + test evidence organized for audits
- Clear audit trail mapping for regulated workflows
- Controlled documentation structure aligned with TechyPharma compliance culture
Regulatory &
Quality Compliance
Coverage
We support validation aligned with common global expectations for regulated computerized systems, including:
- •US FDA 21 CFR Part 11 (Electronic Records & eSignatures)
- •EU GMP Annex 11 (Computerised Systems)
- •GAMP 5 risk-based lifecycle validation principles
- •Data Integrity principles (ALCOA/ALCOA+ applied via controls and evidence)
- •Security & privacy readiness (commonly mapped to ISO 27001 / ISO 27701, GDPR/HIPAA where applicable)
CSV deliverables under this coverage (audit-ready):
- Validation Plan (VP) + Validation Summary Report (VSR)
- User Requirements Specification (URS)
- Functional/Configuration Specifications (FRS/FS)
- Risk Assessment (GxP impact + controls)
- Traceability Matrix (RTM) from requirements → tests → evidence
- Test Protocols & Evidence (IQ/OQ/PQ where applicable)
- SOP set (Change Control, Incident/Deviation, Access Control, Backup/Restore)
- Periodic Review template + revalidation triggers
Use Cases
CRO & Sponsor Inspection Readiness
Validating a New GxP SaaS Deployment
Part 11 / Annex 11 Remediation
Vendor Qualification + Cloud Assurance
Frequently Asked Questions About CSV
CSV is a documented process to ensure software systems meet intended use, comply with GxP requirements, and produce audit-ready evidence.
Typical CSV documentation includes URS, risk assessment, validation plan, RTM, IQ/OQ/PQ test scripts, executed evidence, and validation summary reports.
CSV provides traceable proof that requirements were tested, risks were controlled, and system performance was verified with approved evidence.
Yes — cloud systems still require risk-based validation, access control testing, audit trail verification, and documented evidence for compliance.
Yes — CSV supports impact assessments, regression testing, and documented re-validation evidence for controlled system releases.
Ready to Build Validation Evidence from Day One?
Get risk-based validation, traceability control, and inspection-ready evidence for your regulated systems.