Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Zamann Pharma Support offers specialized consultancy designed to provide comprehensive services to develop necessary documentation, including SOPs, checklists, and workflows, in compliance with applicable regulations, focused on empowering clients with the knowledge and tools required to ensure the Audit Readiness regarding CSV.
We conduct a detailed analysis of regulatory requirements related to CSV audits, including FDA 21 CFR Part 11 and Annex 11 of the EU GMP guidelines.
Our experts assess the regulatory landscape to identify key requirements and expectations for CSV audit readiness, ensuring alignment with industry standards.
Collaborating closely with clients, we develop a tailored strategy outlining the objectives, scope, and methodologies for achieving CSV audit readiness.
We define the roles and responsibilities of stakeholders involved in the audit readiness process and establish timelines for implementation.
Zamann assists in creating a comprehensive documentation framework to support CSV audit readiness efforts. We develop SOPs, checklists, and workflows detailing procedures for CSV system validation, maintenance, and documentation management, ensuring regulatory compliance and audit preparedness.
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.
