Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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We offer specialized services focusing on develop strategies to govern user access within computerized systems. This service aims to ensure regulatory compliance and enhance data security by implementing robust Access Management measures created to the organization’s needs and regulatory requirements.
We conduct a thorough review of relevant regulatory guidelines (e.g.: FDA, EMA, and GAMP5), to identify Access Management requirements.
We analyze existing practices and policies to assess their alignment with regulatory expectations and industry best practices. Identify GAPs and areas for improvement in the current access management framework to guide the development of an effective strategy.
Engagement of stakeholders from various departments to understand user access requirements, roles, and responsibilities across different computerized systems.
Develop proper Access Management strategy that encompasses role-based access controls, authentication mechanisms, password policies, and access provisioning/de-provisioning processes.
Define access control policies, procedures, and guidelines that reflect the organization’s risk tolerance, compliance objectives, and operational needs, ensuring clear and consistent governance of user access.
Our experts performs comprehensive risk assessment to identify potential threats and vulnerabilities associated with user access to computerized systems, considering factors such as data sensitivity, system criticality, and regulatory impact. Implement risk mitigation measures, and establish ongoing monitoring and review processes to proactively identify and address emerging access-related risks, ensuring continuous improvement and adaptation to evolving threats and regulatory requirements.
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.
