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This service entails a comprehensive evaluation of the implemented Master Data Management (MDM) framework, including SOPs, activities, and documents, to ensure compliance with FDA, EMA, and GAMP5 regulations. The primary objective of the MDM GAP assessment is to identify potential gaps and improvements in the MDM system’s adherence to international guidelines, thereby enhancing data integrity and regulatory compliance across the organization.
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 critical aspects such as data integrity, electronic recordkeeping, audit trails, and data security measures. Any discrepancies or deficiencies identified during the review are meticulously documented and categorized based on their impact on compliance and data integrity, forming the basis of our MDM GAP assessment.
We evaluate the existing processes and procedures to identify gaps or deviations from regulatory expectations as part of the MDM GAP assessment. This thorough 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, facilitating targeted improvements.
Our experts conduct a comprehensive review of the system’s adherence to regulatory guidelines for electronic signatures, audit trails, change control, and data retention, among other critical areas. Recommendations are provided to address any identified non-compliance issues, ensuring that the master data management system effectively meets regulatory expectations and supports data integrity objectives. This proactive approach is essential for maintaining a robust MDM framework that aligns with industry 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.
