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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Computerized Systems Validation Audit Readiness – CAPA Plan Management

Zamann Pharma Support provide expert guidance in critically evaluating CAPA plans related to CSV issues, effectively managing all defined tasks, and ensuring alignment between different areas to meet defined due dates. Our comprehensive approach ensures that your organization is well-prepared for CSV audits and capable of addressing any identified non-conformities with precision and efficiency.

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CAPA Plan Evaluation and Alignment

Thoroughly review and assess the CAPA plan to ensure it addresses all identified issues and nonconformities effectively. In collaboration with stakeholders across different departments, we align on CAPA tasks, responsibilities, and timelines. Provide recommendations for enhancing the CAPA plan, including prioritization of tasks and allocation of resources to expedite resolution.

Task Management and Tracking

We establish a robust system for managing and tracking CAPA tasks, including assignment of responsibilities, tracking progress, and monitoring completion status.
Implement effective communication channels to keep stakeholders informed of task updates, deadlines, and any changes to the CAPA plan. Proactively identify and address any delays or roadblocks to ensure timely execution of CAPA tasks and adherence to defined timelines.

Cross-Functional Coordination

Cross-functional collaboration and communication to ensure seamless
coordination between departments, conducting regular meetings or check-ins with relevant stakeholders to review progress, challenges, and make adjustments to the CAPA plan. We act as a central point of contact for coordinating efforts, resolving conflicts, and driving alignment to achieve the overarching goal of audit readiness and compliance.

Tailored Solutions for Digital Transformation

Zamann Pharma Support offers customized digital solutions to streamline pharmaceutical operations. From AI-driven automation to robust platforms like eQMS and LIMS, we ensure seamless integration that enhances efficiency and compliance. Our expert team develops systems tailored to your specific business needs, ensuring optimal performance.

Why Zamann?

Zamann Pharma Support is a leader in delivering innovative digital solutions for the pharmaceutical industry. With extensive experience and specialized knowledge, we understand the unique challenges of digital transformation and regulatory compliance within a GMP framework. We support companies to turn paper based procedures to globally managed and fully digitized solution and have partnered with strong service providers for LMS, LIMS, QMS or Validation solutions.

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