Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Our service provides a comprehensive evaluation of the implemented Access Management framework, including standard operating procedures (SOPs), activities, and documentation, to ensure compliance with FDA, EMA, and GAMP5 regulations. The primary objective is to identify potential gaps and improvements in the Access Management system’s adherence to international guidelines, ultimately enhancing data integrity and ensuring regulatory compliance across the organization.
Our team conducts an extensive review of all relevant documentation, including SOPs, work instructions, data management procedures, and validation protocols. We meticulously 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 our review are thoroughly documented and categorized based on their potential impact on compliance and data integrity, providing a clear roadmap for enhancements.
We assess existing processes and procedures to identify gaps or deviations from regulatory expectations related to Access Management. This evaluation 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 current processes may fall short of regulatory requirements or industry best practices, facilitating targeted improvements to enhance overall compliance and security.
Our experts conduct a thorough review of the system’s adherence to regulatory guidelines for electronic signatures, audit trails, change control, and data retention, among other critical areas. We provide actionable recommendations to address any identified non-compliance issues, ensuring that the Access Management system effectively meets regulatory expectations and supports data integrity objectives. This proactive approach is essential for maintaining a robust Access Management framework aligned 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.
