Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Consultancy focused on evaluation of existing CSV processes, to identify potential GAPs between applied regulations (e.g.: FDA and EMA) and current practices. Our services ensures compliance for future Audits by assessing the background and execution records of the validation process.
We conduct a comprehensive review of FDA and EMA regulations pertaining to computerized system validation, identifying specific requirements and expectations.
Our experts assess the existing validation process against regulatory standards to pinpoint areas of non-compliance or potential gaps.
Zamann performs a detailed GAP analysis to compare the current state of the validation process with regulatory requirements.
We review existing documentation, procedures, and quality records related to computerized system validation to identify discrepancies or deficiencies in compliance.
Based on the findings from the GAP assessment, we provide actionable recommendations and develop a strategic action plan to address identified gaps.
We collaborate closely with clients to prioritize corrective actions, implement process improvements, and enhance compliance with regulatory standards for future audits.
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.
