Ensuring Data Integrity and Audit Readiness
At Indivirtus Healthcare Services Pvt. Ltd., our Laboratory Systems Validation services provide end-to-end qualification of analytical instruments like HPLC, GC, and CDS systems such as Empower. We ensure 21 CFR Part 11 and ICH Q2 compliance through risk-based DQ/IQ/OQ/PQ protocols, delivering audit-ready documentation for QC and R&D labs.
Our services include qualification of analytical instruments (HPLC, GC, UV-Vis) and software (CDS like Empower) through risk-based DQ/IQ/OQ/PQ protocols, method validation per ICH Q2, and 21 CFR Part 11 compliance, ensuring data integrity and regulatory compliance.
Validation ensures consistent performance, data integrity, and audit-readiness for analytical systems, minimizing regulatory risks and ensuring reliable QC/R&D results.
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led validation solutions, providing regulator-ready documentation to support compliance and operational excellence in laboratories.
At Indivirtus Healthcare Services, our Laboratory Systems Validation services are led by certified validation experts with global regulatory expertise. We develop risk-based DQ/IQ/OQ/PQ protocols, validate analytical methods per ICH Q2 for accuracy, precision, linearity, and robustness, and ensure 21 CFR Part 11 compliance for CDS systems like Empower.
Our approach ensures audit-ready systems, aligning with ICH Q2(R2), 21 CFR Part 11, EU GMP Annex 11, USP <1058>, and GAMP 5 standards to support reliable laboratory operations.
User Requirements Specification (URS): Detailed system requirements for validation.
Risk-Based Validation Plan: Tailored strategy for qualification and compliance.
DQ/IQ/OQ/PQ Protocols and Reports: Comprehensive qualification documentation.
Instrument Method Validation (ICH Q2): Validation of analytical methods for accuracy and precision.
21 CFR Part 11 Assessment: Compliance checklist for electronic records and signatures.
Software Validation for CDS like Empower: Validation of Chromatography Data Systems.
Final Validation Summary and Certificate: Audit-ready validation completion report.
Our Laboratory Systems Validation services align with stringent global standards, ensuring your analytical systems are audit-ready and compliant with international regulatory expectations. By adhering to industry-leading guidelines, we deliver solutions that enhance compliance and laboratory reliability.
Our Laboratory Systems Validation services are essential for pharmaceutical and biotech companies ensuring GxP compliance in QC and R&D laboratories. Ideal for HPLC, GC, UV-Vis, and CDS systems like Empower, our solutions support global markets. Key use cases include validating new analytical instruments, ensuring method compliance for regulatory submissions, and preparing labs for FDA/EMA audits.
Indivirtus Healthcare Services is a trusted partner for pharmaceutical and biotech 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 laboratory with compliant, robust validation, driving regulatory success and operational reliability.
We cover a wide range of instruments including HPLC, GC, UV-Vis, FTIR, and associated computerized systems like Empower CDS.
Yes, we perform full ICH Q2 method validation including parameters like accuracy, precision, specificity, linearity, and robustness.
We evaluate software features such as audit trails, electronic signatures, and data integrity controls to ensure compliance with 21 CFR Part 11.
Yes, we offer detailed validation services for Empower CDS including FS/DS, IQ/OQ testing, and access/audit controls.
Absolutely. We align all protocols with USP <1058>, EU GMP Annex 11, GAMP 5, and relevant global regulatory expectations.