COMPLIANCE SOLUTIONS
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COMPLIANCE SOLUTIONS
At ValSquare, we deliver end-to-end Computer System Validation (CSV) and regulatory compliance solutions to ensure your computerized systems operate reliably, securely, and in full compliance with global regulatory requirements. Our compliance approach is risk-based, audit-ready, and aligned with industry best practices.
GAMP 5 Risk-Based Assessment
We apply a structured, risk-based validation methodology in line with GAMP 5 guidelines to ensure systems are fit for intended use, properly controlled, and compliant with regulatory expectations. Our GAMP 5 approach categorizes systems by risk and complexity, enabling efficient validation that focuses resources where they matter most.
Why choose?
Latest equipment
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Safe diagnoses
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Our few benefits
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FDA 21 CFR Part 11 Solutions
Our solutions ensure complete compliance with FDA 21 CFR Part 11 requirements, focusing on electronic records, electronic signatures, system security, audit trails, and data integrity. We help you implement controls that satisfy FDA expectations while maintaining operational efficiency.
EU GMP Annex 11 Solutions
We help organizations meet EU GMP Annex 11 requirements by validating computerized systems used in regulated environments, ensuring proper documentation, system controls, and ongoing compliance throughout the system lifecycle.
ISO ASTM E2500 Solutions
ValSquare supports validation activities based on ISO ASTM E2500, emphasizing a science- and risk-based approach to verifying automated manufacturing systems and critical process controls, ensuring they are fit for intended purpose.
Compliance Matrix
- We offer compliance solutions across all project areas. The compliance level is tailored to your specific user requirements:
- Project Areas: IT Compliance, Manufacturing Process Equipment, Laboratory Instruments, Engineering Systems
- Compliance Frameworks: GAMP 5 Risk Assessment, 21 CFR Part 11, EU Annex 11, ISO ASTM E2500
- All project areas are covered under all four compliance frameworks, with the level of compliance customized based on your specific requirements and risk assessment.
