Ensuring System Integrity with GAMP 5 Methodologies
At Indivirtus Healthcare Services Pvt. Ltd., our Process Automation Validation services ensure PLC, HMI, and SCADA systems meet regulatory and operational standards. Using GAMP 5’s risk-based approach, we deliver audit-ready documentation, verify system configurations, and assess cybersecurity, ensuring compliance and safety in pharmaceutical manufacturing.
Our services include validation of PLC, HMI, and SCADA systems with GAMP 5-compliant risk assessments, FS/DS documentation, configuration reviews, and cybersecurity verification, ensuring regulatory compliance.
Validating automation systems ensures system integrity, regulatory compliance, and safe operation, minimizing risks during audits and ensuring reliable manufacturing processes.
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led validation solutions, providing robust, regulator-ready documentation to support compliance and operational excellence.
At Indivirtus Healthcare Services, our Process Automation Validation services are led by certified validation experts with global regulatory expertise. We apply GAMP 5’s risk-based methodologies to validate PLC, HMI, and SCADA systems, developing FS/DS documentation, test protocols, and cybersecurity assessments.
Our approach ensures audit-ready systems, aligning with ISPE GAMP 5®, US FDA 21 CFR Part 11, EU Annex 11, IEC 62443, and ICH Q9 to support safe and compliant pharmaceutical manufacturing.
Functional & Design Specifications (FS/DS): Detailed system design and functionality documentation.
PLC/HMI/SCADA Configuration Review: Verification of system configurations.
Test Protocols (FAT/SAT/IQ/OQ): Factory/Site Acceptance and Qualification protocols.
Risk Assessment Reports per GAMP 5: Risk-based evaluations for system validation.
21 CFR Part 11 Compliance Checklists: Ensuring electronic record/signature compliance.
Cybersecurity Vulnerability Review: Assessment of system security risks.
Final Validation Summary Report: Comprehensive, audit-ready validation summary.
Our Process Automation 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 Process Automation Validation services are essential for pharmaceutical companies ensuring GxP compliance in automated manufacturing systems. Ideal for PLC, HMI, and SCADA validation, our solutions support global markets. Key use cases include validating new automation systems, ensuring cybersecurity for SCADA platforms, and preparing audit-ready documentation for FDA/EMA 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 automation validation, driving regulatory success and operational reliability.
We validate control systems including PLCs, HMIs, SCADA, and associated software used in pharma manufacturing and utility systems.
Each system is assessed for its impact on patient safety and product quality. Based on this risk level, we tailor the validation depth accordingly.
Yes, we develop and review functional (FS) and design (DS) specifications aligned with URS and process flow for each automation system.
Yes. Our validation includes a security risk assessment based on IEC 62443 and FDA’s draft guidance on cybersecurity in manufacturing.
Our validations align with ISPE GAMP 5, 21 CFR Part 11, EU Annex 11, and applicable data integrity and cybersecurity standards.
Our services include FS/DS documentation, PLC/HMI/SCADA configuration reviews, test protocols (FAT/SAT/IQ/OQ), GAMP 5 risk assessments, 21 CFR Part 11 checklists, cybersecurity reviews, and validation reports.
Pharmaceutical companies validating PLC, HMI, or SCADA systems for manufacturing benefit from our tailored solutions.
Our services align with ISPE GAMP 5®, US FDA 21 CFR Part 11, EU Annex 11, IEC 62443, and ICH Q9, ensuring global compliance.
Clients receive FS/DS, configuration reviews, test protocols, risk assessments, compliance checklists, cybersecurity reviews, and validation reports.
Yes, our services are tailored to your specific automation systems, processes, and regulatory requirements, ensuring compliant solutions.
We provide comprehensive, regulator-compliant documentation and cybersecurity assessments to ensure seamless audits and system reliability.