Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Our team of experts will perform quality audits to check evidences of execution related to the implemented process for Master Data Management, to evaluate compliance with international guidelines (e.g.: FDA, EMA, and GAMP5). The activity covers the holistic evaluation of processes, in order to identify potential GAPs in data management practices, and propose mitigation actions.
Our team conducts on-site audits to review the implemented technical background, including SOPs, work instructions, and validation documentation.
We examine data management practices, data entry processes, data verification procedures, and system access controls to ensure compliance with regulatory requirements. Documentation is scrutinized for accuracy, completeness, and adherence to established standards, with any discrepancies or non-compliance issues documented for further analysis.
During the audit, we verify the integrity of master data records, ensuring that data is accurate, complete, and maintained in accordance with regulatory guidelines.
We review data entry and verification processes to assess the accuracy and reliability of data captured in the system. Additionally, we examine data retention practices, data backup procedures, and disaster recovery plans to safeguard data integrity and ensure business continuity.
Based on the audit findings, we identify any gaps or areas of non-compliance in the master data management system.
We collaborate with stakeholders to develop mitigation plans and corrective actions to address identified gaps and improve compliance with regulatory requirements. Recommendations may include updates to SOPs, additional training for staff, enhancements to data management processes, or system configuration changes to enhance data integrity and regulatory compliance.
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.
