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At Zamann Pharma Support, we conduct thorough preparation audits to evaluate the current status of your Computerized Systems Validation (CSV) activities. Our goal is to identify opportunities for improvement and develop comprehensive CAPA plans to address any identified gaps effectively. Our expert team closely monitors the execution of these CAPA plans, providing ongoing support and guidance to ensure your organization achieves full compliance and is thoroughly prepared for official audits. By focusing on CAPA plan effectiveness, we help you maintain a proactive approach to regulatory requirements.
Our consultants conduct an exhaustive review of your CSV processes, which includes a detailed examination of documentation, procedures, and system configurations. We perform on-site audits to verify the implementation and effectiveness of your CSV activities, ensuring that everything aligns with current regulatory requirements. Through this detailed analysis, we identify any discrepancies between your current practices and the established regulatory standards, highlighting specific areas for improvement. This thorough preparation sets the foundation for effective CAPA plan development and execution, ensuring your organization is audit-ready.
After compiling audit findings, we categorize them based on severity and their potential impact on compliance. Our experts collaborate closely with your team to develop customized Corrective and Preventive Action (CAPA) plans that outline specific actions required to address the identified deficiencies. Each CAPA plan is prioritized according to a risk assessment, and we establish realistic timelines for completion to ensure timely resolution of compliance issues. This structured approach ensures that all CAPA plans are not only actionable but also aligned with your organization’s strategic goals.
Throughout the implementation phase, we provide continuous guidance and support, assisting in the execution of CAPA activities and helping you overcome any challenges that may arise. We conduct regular monitoring of CAPA plan progress to ensure adherence to established timelines and milestones. Completed CAPA activities are thoroughly reviewed, documented, and verified for effectiveness, ensuring that the necessary documentation is maintained for regulatory purposes. By focusing on the success of the CAPA plans, we help your organization achieve sustained compliance and readiness for future audits.
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.
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.
