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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Computerized Systems Validation Audit Readiness – Workshop and Trainings

Through comprehensive workshops and targeted training sessions, we equip your team with the necessary knowledge and skills to ensure compliance with CSV requirements and effectively answer the audits. Our experts guide you through the regulatory standards, risk assessment, and documentation practices, empowering your organization to demonstrate readiness and proficiency during audits.

Clipboard, woman and scientist with computer in laboratory for medical research on cancer drug tria

Needs Assessment and Mapping

We conduct an in-depth assessment to identify existing knowledge GAPs and areas requiring improvement in CSV practices. The mapping process involves evaluating current documentation, procedures, and personnel competencies related to CSV.

Customized Training Program Development

Based on the assessment, we develop training programs designed to address specific deficiencies and enhance your team’s skills and knowledge in CSV. Training modules cover essential topics such as regulatory requirements, validation methodologies, risk assessment, and documentation best practices.

Strategic Audit Preparedness Planning

We collaborate with your organization to develop a strategic plan for effectively responding to external audits, ensuring readiness for inspections by regulatory agencies. The plan includes defining roles and responsibilities, establishing communication channels, and implementing measures to demonstrate compliance during audits.

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.

Modern Laboratory Work Space

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