Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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We provide an strategic guidance on how to be prepared for Computerized Systems Validation audits. This service equips clients with the knowledge and tools necessary to develop effective strategies for audit preparedness, ensuring compliance with regulatory requirements and industry standards.
Provide in-depth analysis of regulatory guidelines such as FDA 21 CFR Part 11 and EU Annex 11 to interpret requirements relevant to computerized systems validation. Offer insights into regulatory expectations and best practices for audit readiness.
We collaborate with clients to develop customized audit preparedness plans based on their specific system configurations, validation needs, and regulatory landscape. Define clear objectives, milestones, and action items to guide the preparation process effectively.
Conduct training sessions and workshops to educate key stakeholders on audit preparation strategies, validation principles, and regulatory compliance requirements. Empower internal teams with the knowledge and skills necessary to implement audit readiness initiatives and effectively respond to auditor inquiries during validation 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.
