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LabWare
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Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Our expert team meticulously reviews Computerized System´s Audit Trails, focusing on key aspects such as post-change assessments, user roles, access management controls, and project or method modifications. We prioritize compliance with FDA requirements to safeguard data integrity and uphold regulatory standards.
Our team conducts comprehensive reviews of Audit Trail data, meticulously analyzing critical events with potential impact on Quality and Safety of batches, system changes, access management activities, and project/method modifications. We scrutinize Audit Trail entries to ensure adherence to FDA regulations, assess data integrity, and identify any anomalies or deviations that may indicate unauthorized access or data manipulation.
We verify compliance with FDA regulations and guidelines pertaining to audit trail management. This involves assessing the completeness, accuracy, and reliability of audit trail data to ensure it captures all relevant system activities and meets regulatory requirements outlined in FDA’s 21 CFR Part 11 and other relevant guidance documents.
Our team evaluates system configurations, user permissions, and data retention practices to mitigate risks and maintain compliance.
We conduct risk assessments based on Audit Trail review findings to identify potential vulnerabilities or areas of non-compliance within the computerized system. We assess the impact of audit trail discrepancies on data integrity, product quality, and regulatory compliance. Our experts develop risk mitigation strategies, implement corrective actions, and enhance system controls to address identified issues and prevent recurrence, thereby ensuring the reliability and accuracy of audit trail data.
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.
