A validation assessment program is a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality.
- Regulatory Applicability Assessment Report
- Requirement Traceability Matrix
- Test Plan and Test Evaluation Report
- Error Validation and Resolution Report
- Final Test Report: IQ and OQ Report
- Regulatory Compliance Assessment Report
- Standard Operating procedures
- Training the resources
- Validation Summary Report
Verification and Validation using the V-model
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