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 thorough preparation audits to evaluate your current status of CSV activities, identify opportunities of improvement, and develop comprehensive CAPA plans to address any GAPs. Our expert team then closely monitors the execution of CAPA plans, providing ongoing support and guidance to ensure full compliance and readiness for official audits.
Our consultants conduct a comprehensive review of your computerized systems validation (CSV) processes, including documentation, procedures, and system configurations.
We perform on-site audits to verify the implementation and effectiveness of your CSV activities, ensuring alignment with regulatory requirements. Detailed analysis is carried out to identify any discrepancies between current practices and regulatory standards, highlighting areas for improvement.
We compile audit findings and categorize them based on severity and impact on compliance. Our experts work closely with your team to develop customized Corrective and Preventive Action (CAPA) plans, outlining specific actions to address identified deficiencies. Each CAPA is prioritized based on risk assessment, and a realistic timeline is established for completion to ensure timely resolution of compliance issues.
We provide guidance and support throughout the implementation phase, assisting in the execution of CAPA activities and overcoming any challenges encountered.
Regular monitoring of CAPA plan progress is conducted to ensure adherence to timelines and milestones. Completed CAPA activities are thoroughly reviewed, documented, and verified for effectiveness, with proper documentation maintained for regulatory purposes.
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.
