Computer System Validation (CSV) Services: Secure Your Systems. Safeguard Your Science.
In the digital age, a system is only as reliable as its validation. Outdated, paper-based validation processes are a major source of inefficiency and audit risk. The FDA, EMA, and other agencies are no longer looking for check-box compliance; they're demanding a risk-based approach that proves your systems are fit for purpose.
GenBioCa specializes in Computer System Validation (CSV) and GAMP 5 compliance, ensuring your systems are meticulously tested and documented. We don't just generate paperwork; we implement a modern, risk-based validation strategy that leverages automation to reduce the validation lifecycle. Our services include data integrity assessments, cloud-based system validation, and continuous monitoring to ensure your systems remain in a validated state throughout their entire lifecycle. With us, you're not just compliant, you are audit-ready, 24/7.
Comprehensive CSV Services for the Pharmaceutical Industry: Smart Validation for Pharma
In the critical Pharmaceutical landscape, GenBioCa delivers intelligent Validation Services that ensure compliance and efficiency. Our core differentiator: Risk-based Validation Powered by Integrated Digital Tools, providing enhanced control and regulatory confidence.
We Worked With Reputed Companies in The World
- Risk-Based Validation Planning & Strategy: Tailored plans based on thorough risk assessments, digitally managed for optimal resource allocation.
- Computer System Validation (CSV): Expert, risk-based CSV ensuring compliance with regulations like 21 CFR Part 11 and Annex 11 through digital tools.
- Equipment & Instrument Qualification (IQ, OQ, PQ): Meticulous qualification with digital data capture for accuracy and streamlined reporting.
- Process Validation: Risk-based approach utilizing digital platforms for data-driven insights and control.
- Clean room Validation: Robust protocols with digitally managed testing and documentation for effective cleaning procedures and environmental control.
- Method Validation: Rigorous validation employing digital platforms for accurate and reliable analytical methods.
- Validation Lifecycle Management: Rigorous validation employing digital platforms for accurate and reliable analytical methods. through integrated digital systems for enhanced control and traceability
Where Quality, Affordability, and Innovation Meet
- Enhanced Regulatory Confidence: Achieved through risk-based, digital documentation that stands up to scrutiny.
- Increased Efficiency & Reduced Timelines: Digital tools and a focused strategy accelerate your time-to-market.
- Improved Data Integrity & Traceability: Secured via secure digital platforms that ensure all data is auditable.
- Data-Driven Decision Making: Real-time insights and comprehensive reports enable superior control.
- Reduced Costs: Optimizing investment through a risk-focused approach and digital efficiency.
GenBioCa offers a validation solution for the life sciences industries, specifically tailored for implementing or upgrading to SAP S/4HANA, whether on-premise, cloud, or hybrid.
- Industry Expertise: The GenBioCa Advantage Validation service is built on extensive industry knowledge and expertise gained through years of experience working with pharmaceutical, medical device, and biotechnology companies.
- SAP Compliance Service: GenBioCa’s SAP compliance service ensures timely and cost-effective compliance with both domestic and international authorities, including BfArM, FDA, HPRA, MHRA, and TGA.
- Equipment & Instrument Qualification (IQ, OQ, PQ): Meticulous qualification with digital data capture for accuracy and streamlined reporting.
- Process Validation: Risk-based approach utilizing digital platforms for data-driven insights.
- Clean room Validation: Robust protocols with digitally managed testing and documentation for effective cleaning procedures.
- Method Validation: Rigorous validation employing digital platforms for accurate and reliable analytical methods.
- Validation Lifecycle Management: Comprehensive support managed through integrated digital systems for enhanced control and traceability
The GenBioCa Advantage
Validation, Evolved.
Our approach is rooted in precision and efficiency, validated by our commitment to Quality (ISO 9001) and Information Security (ISO 27001).
Risk-Based
Precision
We focus validation efforts on high-risk areas, maximizing resource efficiency with digital documentation and tracking.
Digital-First Efficiency
Our advanced digital platforms streamline documentation, enhance traceability, and provide real-time insights for faster, more transparent validation.
End-to-End
Expertise
From planning to lifecycle management, our comprehensive services are powered by digital systems for superior control.
Client Success Story
Case Study: Validation – Product Challenge
A client using a data encryption tool for compliance needed it evaluated for GDPR/HIPAA adherence. GenBioCa derived evaluation criteria from the User Requirements Specification (URS), executed IQ/OQ/PQ on the product version, and provided a comprehensive Validation Summary Report with detailed findings
Ready For Smarter Validation
Visit www.genbioca.com or contact gbc@genbioca.com to explore our Pharma-focused Validation Services. For more information, please refer