Secure Your Systems with Expert Validation and Audits
Indivirtus Healthcare Services delivers specialized Data Integrity and Computer System Validation (CSV) services to ensure compliance with 21 CFR Part 11, ALCOA+ principles, and global standards. Our expert audits and technical support help pharmaceutical and life science companies maintain data integrity and achieve regulatory readiness.
Data Integrity ensures that data remains accurate, complete, and reliable throughout its lifecycle. Computer System Validation (CSV) confirms that computerized systems in GxP environments meet regulatory standards, such as 21 CFR Part 11, for security and traceability.
Maintaining data integrity and validated systems is critical to ensure patient safety, avoid regulatory penalties, and build trust in your operations. Compliance with global standards like 21 CFR Part 11 ensures audit readiness and operational reliability.
Indivirtus Healthcare Services provides end-to-end support for data integrity and CSV, offering audits, system validations, and technical guidance. We align your systems with global regulatory expectations, ensuring robust data governance.
At Indivirtus Healthcare Services, our approach to Data Integrity and Computer System Validation is thorough and tailored. Our team of certified professionals conducts detailed assessments, including audit trail verification, data backup evaluations, and computerized system qualifications. We align with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and more) to ensure data reliability across GxP environments. Our CSV services include developing comprehensive validation plans and providing ongoing technical support to address compliance gaps, ensuring your systems are secure and inspection-ready.
Data Integrity Audit Report: A comprehensive report detailing findings, risks, and recommendations for compliance.
CSV Master Plan: A strategic plan outlining the validation process for computerized systems in GxP environments.
Audit Trail & Backup Validation Summary: Documentation verifying the integrity of audit trails and data backup systems.
21 CFR Part 11 Compliance Checklist: A practical tool to ensure adherence to FDA regulations for electronic records and signatures.
Our Data Integrity and CSV services are built to meet stringent global regulatory standards, ensuring your systems are robust and audit-ready. By adhering to industry-recognized guidelines, 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 and operational trust.
Our Data Integrity and CSV services are designed for pharmaceutical and life science companies managing computerized systems in GxP environments. We support a range of applications, including electronic batch records, laboratory information management systems (LIMS), and quality management systems. Our services are ideal for companies implementing new systems, addressing data integrity gaps, or preparing for regulatory inspections. Whether you’re ensuring audit trail compliance or aligning with 21 CFR Part 11, our tailored solutions help you achieve regulatory success and operational reliability.
Indivirtus Healthcare Services stands out with our team of certified experts, bringing extensive experience in global regulatory compliance. Our scientifically robust audits and validations ensure your systems meet the highest standards of data integrity. We prioritize rapid turnaround times, delivering actionable insights to maintain compliance and trust. With a commitment to confidentiality and industry best practices, we partner with you to safeguard your data and achieve regulatory success across global markets.
CSV ensures that computerized systems used in regulated processes consistently produce reliable and accurate results in line with regulatory expectations like GAMP 5 and 21 CFR Part 11.
ALCOA+ principles ensure that data is Attributable, Legible, Contemporaneous, Original, Accurate, and also Complete, Consistent, Enduring, and Available throughout its lifecycle.
Audit trail verification confirms that changes to data are tracked and traceable, which is critical for regulatory inspections and maintaining data credibility.
Indivirtus assesses and validates electronic records and signature systems, ensuring they meet all requirements of 21 CFR Part 11 through gap analysis and validation documentation.
The CSV Master Plan outlines the validation strategy, roles, documentation structure, and risk-based approach for all computerized systems used in GxP environments.
Data Integrity ensures data is accurate, complete, and reliable throughout its lifecycle. CSV verifies that computerized systems in GxP environments meet regulatory requirements, such as 21 CFR Part 11, for security, traceability, and compliance.
Compliance with 21 CFR Part 11 ensures that electronic records and signatures are secure, trustworthy, and equivalent to paper records, meeting FDA standards and preventing regulatory penalties.
We provide a Data Integrity Audit Report, CSV Master Plan, Audit Trail & Backup Validation Summary, and a 21 CFR Part 11 Compliance Checklist to support regulatory compliance.
Our services align with 21 CFR Part 11, MHRA Data Integrity Guidance, EU Annex 11, and WHO Guidance on Data Integrity, ensuring global compliance.
We adhere to strict confidentiality protocols and industry best practices, protecting your sensitive data throughout the audit and validation process.
We validate a variety of GxP systems, including electronic batch records, laboratory information management systems (LIMS), quality management systems, and other computerized systems.