Smart Validation for Pharma: Risk-Based, Digitally Driven.

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.

The GenBioCa Advantage: Validation, Evolved.

• 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.

Our Intelligent Validation Services:

• 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.
• 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.

Benefits of Choosing GenBioCa:

• Enhanced Regulatory Confidence through risk-based, digital documentation.
• Increased Efficiency & Reduced Timelines with digital tools and focused strategy.
• Improved Data Integrity & Traceability via secure digital platforms.
• Data-Driven Decision Making with real-time insights and comprehensive reports.
• Scalable & Adaptable Solutions tailored to your specific needs.
• Reduced Costs by optimizing investment through risk focus and digital efficiency.

Case Study: Validation – Product

Challenge:

Data encryption tool was used company for compliance. It offered masking, encryption and other features, and company asked for the product to be evaluated for compliance to GDPR/HIPAA.

Solution:

Evaluation criteria was derived from the URS, IQ/OQ/PQ was done on the specification from the product company Version X.0, clarifications were sought with the product company.

Results: Validation summary report for the product was shared with findings.

Ready for Smarter Validation?

Visit www.genbioca.com or contact sales@genbioca.com to explore our digital-first validation solutions.

For more information, please refer Validation Services Brochure

SAP VALIDATION

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.
• Comprehensive Compliance Offering: Instead of manual validation efforts, GenBioCa’s service incorporates industry best practices, offering tools such as Business Requirements model, Validation Plan template, Traceability Matrix, Installation Qualification test scripts, Operation Qualification test scripts, Performance Qualification template, and Validation Summary Report template.
• Full Maintenance Program: The Full Maintenance Program supports validation documentation integrity for GenBioCa’s enterprise software compliance packages, ensuring updated documentation along with ongoing regulatory compliance expertise.
• SAP S/4HANA Business Suite: GenBioCa emphasizes SAP S/4HANA as an ERP solution for pharmaceutical, medical device, and biotechnology industries, providing a powerful solution with industry-specific functionality for on-premise, cloud, or hybrid deployments.
• Deployment Scenarios: The on-premise deployment involves a company managing its server, database, applications, and data center. In contrast, SAP S/4HANA Cloud is a fully managed option where SAP handles hardware, software, and database maintenance.
• Hybrid Options: GenBioCa highlights hybrid options, including Infrastructure-as-a-Service mode, allowing flexibility for companies rapidly growing and in need of a versatile platform.
• Validation Requirements: GenBioCa stresses the importance of validating SAP S/4HANA, whether on-premise or in the cloud, to meet regulatory agency requirements. SAP’s compliance includes data privacy acts and industry-specific data protection legislation.
• GenBioCa Assurance: The SAP validation service by GenBioCa assures maximum investment protection, providing benefits such as shorter timeframes for compliance certification, reducing the risk of regulatory scrutiny, and facilitating faster time-to-value for commercial business software investments.

For more information, please refer SAP Validation Brochure

1. What is Computer System Validation (CSV)?

CSV is a documented process that ensures computer systems used in pharmaceutical operations function as intended, comply with regulatory standards, and maintain data integrity, security, and reliability.’

2. Why is CSV important in the pharmaceutical industry?

CSV ensures that critical systems used in R&D, manufacturing, quality control, and distribution operate correctly, reducing risks such as product recalls, regulatory non-compliance, and compromised patient safety.

3. What regulatory standards does GenBioCa’s CSV service comply with?

GenBioCa ensures compliance with key global regulations, including:

• FDA 21 CFR Part 11
• EU GMP Annex 11
• ICH Q7/Q9/Q10
• GAMP 5
• MHRA & WHO Guidelines

4. What is GenBioCa’s approach to CSV?

GenBioCa follows a structured validation process that includes:

1. Planning – Defining scope, developing a validation plan, and aligning with client needs.
2. Design – Configuring systems to meet predefined specifications.
3. Testing – Performing rigorous testing (Unit, Integration, System, UAT).
4. Documentation – Creating detailed validation records for compliance and audit readiness.




5. What types of validation services does GenBioCa offer beyond CSV?

In addition to Computer System Validation, GenBioCa provides:

• Equipment Validation
• SAP Validation
• Cloud Validation
• Clean Room Validation
• Data Center Validation
• Blockchain, IoT/Sensor, and Mobility Solution Validation

 



6. How does GenBioCa ensure data integrity in validated systems?

We implement industry best practices, including audit trails, electronic signature controls, role-based access, and data encryption, ensuring compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).



7. What are the key benefits of partnering with GenBioCa for CSV?
• Regulatory Compliance: Adherence to global pharma standards.
• Risk Mitigation: Reducing chances of system failures and regulatory penalties.
• System Security: Strengthening cybersecurity and data protection.
• Data Integrity: Ensuring accuracy, consistency, and traceability.

 



8. How does GenBioCa support audit readiness?

We provide comprehensive documentation, including:

• Validation Plans
• Test Protocols & Reports
• Risk Assessments
• Final Validation Reports
  All documentation ensures traceability and regulatory compliance.

 



9. How long does the CSV process take?

The duration varies based on system complexity, scope, and regulatory requirements. GenBioCa works closely with clients to establish realistic timelines while ensuring thorough validation.



10. Can GenBioCa validate cloud-based and SaaS applications?

Yes, GenBioCa provides cloud validation services, ensuring compliance with regulatory requirements for SaaS-based applications, cloud-hosted solutions, and hybrid environments.



11. What industries does GenBioCa serve for validation services?

While primarily serving the pharmaceutical industry, GenBioCa also supports biotechnology, medical devices, healthcare IT, and life sciences organizations with validation solutions.



12. How can I get started with GenBioCa’s validation services?



You can contact us through our website, email, or phone to schedule a consultation. Our team will assess your validation needs and develop a tailored approach to ensure compliance and operational efficiency.