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Expert consultants at Zamann Pharma Support conduct essential periodic reviews of validated computerized systems to ensure ongoing compliance with regulatory requirements and industry standards. We assist clients in preserving the integrity, reliability, and security of their systems through regular assessments and timely updates, thereby facilitating an effective CSV periodic review process.
We perform a detailed examination of all relevant changes made—both directly and indirectly—to the computerized system since the last review cycle. This includes analyzing software updates, configuration modifications, data migrations, and other alterations that affect system functionality or regulatory compliance. Our team thoroughly assesses the impact of these changes on the validation status, ensuring that appropriate validation activities are executed to maintain CSV status.
Our experts carry out an evaluation of the qualification status of the IT infrastructure that supports the computerized system. This assessment involves reviewing qualification documents related to servers, networks, databases, and other infrastructure components. We verify compliance with regulatory requirements, evaluate the effectiveness of qualification activities, and identify any gaps or deficiencies that need corrective action to uphold system reliability and compliance within the context of CSV periodic reviews.
We conduct a comprehensive assessment of suppliers and service providers associated with the computerized system, including software vendors, hardware suppliers, and maintenance providers. Our evaluation covers supplier qualification status, adherence to contractual agreements, responsiveness to corrective actions, and the overall quality of products or services delivered. This thorough supplier evaluation is crucial for ensuring the reliability of the computerized system and maintaining compliance during CSV periodic reviews.
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.
