Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Providing essential templates for executing CSV activities in accordance with FDA, EMA, and GAMP5 requirements, we deliver a comprehensive set of documents, including User Requirement Specifications (URS), Risk Assessments, Traceability Matrix, Protocols and Reports related to all Validation steps (e.g.: IQ, OQ, and PQ).
Our experts conduct a comprehensive assessment of the client’s systems and processes to identify specific requirements and potential risks.
Based on this assessment, we tailor templates for each operational document to ensure they address the unique needs of the client’s systems and comply with regulatory guidelines.
These customized templates are designed to capture all relevant information effectively, facilitating a structured approach to CSV execution while minimizing the risk of oversights or compliance GAPs.
Our team provides a range of standardized templates for validation protocols and reports, covering all stages of the validation lifecycle.
These templates are meticulously crafted to include sections for essential details such as system specifications, testing procedures, acceptance criteria, and results documentation.
By leveraging these pre-defined templates, clients can expedite the preparation of validation documentation while ensuring consistency and compliance with regulatory requirements across all validation activities.
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.
