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Acting as an external PMO, our goal is to oversee and manage the implementation of new Computerized Systems with a strong emphasis on CSV management and quality aspects. We ensure that all project activities align with regulatory requirements and industry best practices, facilitating a smooth and efficient implementation process while maintaining a focus on quality assurance and validation throughout the project lifecycle.
We develop comprehensive project plans that outline key milestones, deliverables, timelines, and resource allocations, specifically incorporating CSV management principles. Our team oversees the execution of project activities, ensuring adherence to quality standards, regulatory requirements, and project timelines. We proactively identify and address any potential issues or risks that may arise during the implementation process to minimize disruptions and ensure project success, with a strong emphasis on maintaining data integrity and compliance.
We provide rigorous Quality Assurance oversight throughout the implementation process, ensuring that all project activities adhere to established quality standards and regulatory requirements. Our team conducts regular reviews and audits of project documentation, deliverables, and processes to verify compliance and identify areas for improvement. By focusing on CSV management, we work closely with project stakeholders to address any quality-related issues promptly and effectively, maintaining a high level of quality throughout the implementation lifecycle.
We oversee the validation activities associated with the implementation of Computerized Systems, ensuring that requirements are clearly defined, documented, and executed according to regulatory guidelines. Our team collaborates closely with internal teams, including IT, vendors, and regulatory authorities, to ensure that all validation activities are completed successfully and in accordance with regulatory expectations. This collaborative approach ensures that CSV management is prioritized, enhancing the overall quality and compliance of the implemented systems.
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.
