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Our team of seasoned experts specializes in conducting quality master data management audits that scrutinize the execution of processes related to Master Data Management. Our approach integrates a thorough evaluation to assess compliance with stringent international guidelines, such as those from the FDA, EMA, and GAMP5. This comprehensive audit activity not only identifies potential gaps in data management practices but also determines whether protocols are adhered to. By proposing tailored mitigation actions, we ensure that organizations can effectively enhance their data management strategies and address any areas requiring improvement to meet regulatory expectations.
Our highly skilled team conducts detailed on-site audits to evaluate the technical framework established within the organization, focusing on critical documents like Standard Operating Procedures (SOPs), work instructions, and all relevant validation documentation. During the audit, we meticulously examine various data management practices, including data entry processes, verification procedures, and system access controls, to assess their compliance with regulatory requirements. Each piece of documentation is rigorously reviewed for accuracy, completeness, and alignment with established standards. Any discrepancies or non-compliance issues identified during this thorough examination are documented for further analysis, which informs future improvements.
During the master data management audit, we prioritize verifying the integrity of master data records, ensuring that all data is not only accurate but also complete and maintained according to regulatory guidelines. Our review includes a close examination of data entry and verification processes, assessing the overall accuracy and reliability of the data captured within the system. Additionally, we focus on analyzing data retention practices, backup procedures, and disaster recovery plans. This examination is crucial for safeguarding data integrity and ensuring business continuity in the face of potential disruptions while maintaining compliance with relevant regulations.
Based on the findings from the comprehensive audit, we identify and document any gaps or areas of non-compliance within the master data management system. Our collaborative approach involves working closely with key stakeholders to develop effective mitigation plans and corrective actions that specifically address these identified gaps. By prioritizing compliance with regulatory requirements, we aim to enhance the overall robustness of the data management framework. Our recommendations may include updating SOPs, providing additional training for staff, improving data management processes, or making necessary changes in system configuration to fortify data integrity and compliance with applicable standards.
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.
