a UNICON Company

Core Service Group offers specialized computer system validation (CSV) services to address the complex regulatory landscape of the pharmaceutical and biotech industries. Our expertise in GxP systems ensures that your critical applications are validated to the highest standards, mitigating risks and safeguarding product quality.

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Our CSV Services Include:

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• Risk-Based Validation Approach: Implementing tailored validation strategies based on system complexity and criticality.

• Gap Analysis and Remediation: Identifying compliance gaps and providing effective remediation plans.

• Validation Lifecycle Management: Supporting your system throughout its entire lifecycle, from design to decommissioning.

• Regulatory Compliance: Ensuring adherence to FDA 21 CFR Part 11, EU Annex 11, and other relevant regulations.

• Data Integrity Management: Protecting data accuracy, completeness, and consistency.

• Change Control Management: Managing system changes effectively to maintain validation status.

• Audit and Inspection Support: Preparing for and supporting regulatory audits and inspections.

 

Why Choose Core Service Group?

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• Deep Industry Knowledge: Our experts possess in-depth understanding of GxP regulations and industry best practices.

• Proven Methodology: We follow established CSV methodologies and frameworks.

• Customized Solutions: Tailored approach to meet your specific business needs and system requirements.

• Efficient Project Execution: Streamlined processes and effective project management for timely delivery.

 

By partnering with Core Service Group, you can achieve robust CSV compliance, reduce validation costs, and minimize regulatory risks.

 

Contact us today to discuss your CSV challenges and explore how our expertise can help you achieve compliance and business success.