Safeguard Your Data with Expert Audits and Validation
Indivirtus Healthcare Services delivers specialized Data Integrity and Computer System Validation (CSV) services to ensure compliance with 21 CFR Part 11 and global standards. Our expert audits and technical support help pharmaceutical companies maintain data integrity, ensuring regulatory readiness and operational trust.
Data Integrity ensures that data is accurate, complete, and reliable throughout its lifecycle. Computer System Validation (CSV) verifies that computerized systems in GxP environments meet regulatory requirements, such as 21 CFR Part 11, for data security and traceability.
Compliance with data integrity standards prevents regulatory penalties, ensures patient safety, and maintains trust in your operations. Proper CSV ensures systems are reliable, secure, and audit-ready for global regulatory inspections.
Indivirtus Healthcare Services provides comprehensive audits and validation services to align your systems with 21 CFR Part 11, ALCOA+ principles, and global guidelines. We help you achieve robust data governance and regulatory compliance.
At Indivirtus Healthcare Services, we take a meticulous approach to Data Integrity and Computer System Validation. Our certified professionals conduct thorough assessments, including audit trail verification, data backup evaluations, and system qualification, to ensure compliance with global standards. We align with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and more) to safeguard data integrity across GxP environments. Our services include developing tailored CSV Master Plans and providing technical support to address gaps, ensuring your systems are secure, compliant, and ready for regulatory scrutiny.
Data Integrity Audit Report: A detailed report identifying risks, non-conformities, and recommendations for compliance.
CSV Master Plan: A strategic roadmap outlining the validation process for computerized systems.
Audit Trail & Backup Validation Summary: Documentation verifying the integrity of audit trails and data backup processes.
21 CFR Part 11 Compliance Checklist: A practical tool to ensure adherence to FDA’s electronic records and signatures regulations.
Our Data Integrity and CSV services are designed to meet stringent global regulatory requirements, ensuring your systems are audit-ready and compliant. By adhering to industry standards, we provide scientifically defensible solutions that support inspections by regulatory bodies like the FDA, MHRA, and WHO. Our expertise ensures your data governance aligns with international expectations, facilitating seamless compliance.
Our Data Integrity and CSV services are essential for pharmaceutical and life science companies managing computerized systems in GxP environments. Whether you’re implementing new systems, upgrading existing ones, or preparing for regulatory inspections, our services ensure compliance and reliability. We support applications such as electronic batch records, laboratory information management systems (LIMS), and quality management systems. Our audits and validations are ideal for companies addressing data integrity gaps, ensuring audit trail compliance, or seeking to align with 21 CFR Part 11 for global market access.
Indivirtus Healthcare Services brings unmatched expertise in Data Integrity and Computer System Validation, with a team of certified professionals experienced in global regulatory requirements. Our scientifically robust audits and validations ensure your systems are secure and compliant. We prioritize rapid turnaround times, delivering actionable insights to maintain data integrity and regulatory readiness. With a commitment to confidentiality and industry best practices, we help you build trust in your operations and achieve compliance with confidence.
CTD (Common Technical Document) and eCTD (electronic format) are structured formats for submitting regulatory dossiers to agencies like the FDA and EMA.
Yes, we support NDA, ANDA, IND, DMF, CEP, and MAA submissions with complete dossier lifecycle management.
Absolutely. Our team conducts detailed reviews to ensure your CMC sections meet global regulatory expectations.
We help prepare documentation, mock queries, and inspection checklists to ensure your site and team are fully PAI-ready.
Dossier compilation timelines range from 2 to 6 weeks depending on dossier complexity and available documentation.