Ensuring Secure and Compliant Digital Ecosystems
At Indivirtus Healthcare Services Pvt. Ltd., our Enterprise Application Validation services ensure SAP, LIMS, and QMS systems meet global regulatory standards. We provide GAMP 5-compliant CSV, 21 CFR Part 11 audits, and comprehensive documentation to ensure data integrity and audit-readiness for FDA, EMA, and MHRA requirements.
Our services include Computer System Validation (CSV) for SAP, LIMS, and QMS platforms, with URS, FS/DS, risk assessments, and 21 CFR Part 11 compliance audits, ensuring regulatory compliance and data integrity.
Validating enterprise systems ensures data integrity, regulatory compliance, and secure operations, minimizing risks during audits and ensuring reliable digital processes.
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led validation solutions, providing regulator-ready documentation to support compliance and operational excellence in pharmaceutical digital ecosystems.
At Indivirtus Healthcare Services, our Enterprise Application Validation services are led by certified validation experts with global regulatory expertise. We apply GAMP 5’s risk-based methodologies to validate SAP, LIMS, and QMS systems, developing URS, FS/DS, and conducting data integrity audits.
Our approach ensures audit-ready systems, aligning with 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH Q9 guidelines to support compliant and secure pharmaceutical operations.
User Requirements Specification (URS): Detailed system requirements for validation.
Functional & Design Specifications (FS/DS): Comprehensive system design documentation.
CSV Compliance Report: Validation results per GAMP 5 standards.
21 CFR Part 11 Audit Summary: Compliance assessment for electronic records and signatures.
Risk & Data Integrity Assessment: Risk-based evaluations for system integrity.
Traceability Matrix & Summary Report: Mapping requirements to validation outcomes.
Our Enterprise Application Validation services align with stringent global standards, ensuring your systems are audit-ready and compliant with international regulatory expectations. By adhering to industry-leading guidelines, we deliver solutions that enhance compliance and system reliability.
Our Enterprise Application Validation services are essential for pharmaceutical companies ensuring GxP compliance in digital ecosystems. Ideal for SAP, LIMS, and QMS systems, our solutions support global markets. Key use cases include validating new enterprise platforms, ensuring data integrity for regulatory audits, and supporting compliance for FDA/EMA/MHRA inspections.
Indivirtus Healthcare Services is a trusted partner for pharmaceutical companies, delivering expert-led validation solutions backed by certified professionals with global experience. Our services ensure regulator-ready outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, robust system validation, driving regulatory success and operational reliability.
We validate systems like SAP, LIMS, QMS, and other enterprise platforms used in regulated pharmaceutical operations.
We assess access controls, audit trails, electronic signatures, and system architecture to ensure alignment with 21 CFR Part 11.
Yes, we prepare URS, FS, DS, testing protocols, traceability matrices, and summary reports tailored to your systems.
We review system processes, data flows, and controls to detect vulnerabilities that could compromise data quality or integrity.
Yes, our approach follows the GAMP 5 V-model and categorization of software types to ensure risk-based and efficient validation.
Our services include URS, FS/DS, CSV compliance reports, 21 CFR Part 11 audits, risk and data integrity assessments, and traceability matrices for SAP, LIMS, and QMS systems.
Pharmaceutical companies implementing or maintaining SAP, LIMS, or QMS systems benefit from our tailored validation solutions.
Our services align with 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH Q9, ensuring global regulatory compliance.
Clients receive URS, FS/DS, CSV reports, 21 CFR Part 11 summaries, risk assessments, and traceability matrices.
Yes, our services are tailored to your specific enterprise systems and regulatory requirements, ensuring compliant solutions.
We provide comprehensive, regulator-compliant documentation and audits to ensure seamless regulatory inspections and data integrity.