Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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We conduct a detailed evaluation of the client’s existing CSV framework, including VMP, SOPs, IT infrastructure, and document templates, to identify potential GAPs or deficiencies in compliance with FDA, EMA, and GAMP5 regulations. This assessment aims to ensure that the company’s CSV processes align with industry standards and regulatory requirements, mitigating risks and enhancing overall compliance posture.
Our team meticulously examines the client’s CSV background, like SOPs and all relevant documents, to assess their adequacy and alignment with
regulatory guidelines.
We identify any discrepancies or GAPs in the documentation, such as missing steps, outdated records, or inconsistencies in content, to form the basis of our GAP analysis.
We evaluate the client’s IT Infrastructure Qualification, to determine its suitability for supporting CSV activities, including considerations such as system architecture, data integrity measures, and cybersecurity protocols.
This assessment helps identify potential vulnerabilities or deficiencies in the IT infrastructure that may impact the integrity and compliance of computerized systems.
Our experts review the client’s document templates used for CSV activities to ensure they meet regulatory requirements and industry best practices.
We assess the comprehensiveness, accuracy, and consistency of templates such as URS, Risk Assessments, Traceability Matrix, and Protocols to optimize their effectiveness in supporting the validation process.
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.
