COMPUTER SYSTEM VALIDATION (CSV)
Pharmaceutical Computerized System Validation, GxP Compliance & Data Integrity
Mindsphire Pharma Labs & Solution provides pharmaceutical organizations with support for computerized system validation, GxP compliance, data integrity, and digital-system lifecycle management.
Our approach focuses on intended use, system criticality, risk-based validation, documented evidence, traceability, and maintaining the validated state throughout the system lifecycle.
We support validation activities aligned with applicable regulatory requirements and recognized industry guidance, including 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 principles.
Computerized System Validation (CSV)
We support the planning, execution, documentation, and lifecycle management of computerized system validation activities for GxP-relevant systems.
Our services include validation strategy development, system criticality assessment, risk-based validation planning, qualification support, test execution documentation, requirements traceability, and validation summary reporting.
GxP Compliance & Regulatory Assessment
Welcome to our service portfolio, offering expert assessment and validation for various systems, including Manufacturing Execution Systems (MES) and Electronic Batch Records (eBMR/eBPR). We ensure compliance with 21 CFR Part 11 and EU GMP Annex 11, following GAMP 5 principles. Trust us to maintain the integrity and reliability of your systems while ensuring regulatory.
Data Integrity & Electronic Records
Support for reviewing audit trails, access controls, electronic records, electronic signatures, record retention, retrieval, and backup arrangements.
Validation Documentation & Qualification
Preparation and support for URS, functional and technical specifications, risk assessments, IQ/OQ/PQ, UAT, test scripts, traceability matrices, and validation reports.
CSV Remediation & Change Control
Support for legacy-system assessments, validation documentation remediation, change-impact assessments, regression testing strategies, deviation management, and CAPA.
Periodic Review & Lifecycle Compliance
Periodic system reviews, validation-status assessments, backup and restore verification, supplier assessments, and revalidation decision support.