Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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This service entails a comprehensive evaluation of the implemented Master Data Management (MDM) background, including SOPs, activities and documents, to ensure compliance with FDA, EMA, and GAMP5 regulations. The primary objective is to identify potential GAPs and improvements in the MDM system’s adherence to international guidelines, thereby enhancing data integrity and regulatory compliance.
Our team conducts a thorough review of all relevant documentation, including SOPs, work instructions, data management procedures, and validation protocols.
We analyze these documents to assess their alignment with FDA, EMA, and GAMP5 requirements, focusing on data integrity, electronic recordkeeping, audit trails, and data security measures. Any discrepancies or deficiencies identified during the review are documented and categorized based on their impact on compliance and data integrity.
We evaluate the existing processes and procedures to identify GAPs or deviations from regulatory expectations. This assessment encompasses data entry and verification processes, data migration activities, data maintenance procedures, and data archival practices. Through detailed process mapping and gap analysis, we pinpoint areas where the current processes may fall short of regulatory requirements or industry best practices.
Our experts review the system’s adherence to regulatory guidelines for electronic signatures, audit trails, change control, and data retention, among others. Recommendations are provided to address any identified non-compliance issues, ensuring that the master data management system meets regulatory expectations and supports data integrity objectives effectively.
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.
