Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Zamann Pharma Support provides strategic guidance to clients in implementing Computerized Systems Validation (CSV) activities. We assist clients in creating a comprehensive strategy tailored to their specific needs and regulatory requirements, enabling them to effectively navigate the complexities of CSV implementation.
Our team conducts a thorough review of relevant regulatory requirements, including FDA 21 CFR Part 11 and EU Annex 11, to ensure a comprehensive understanding of compliance obligations.
We meticulously analyze these regulations to identify specific requirements related to CSV activities, such as data integrity, electronic records, and electronic signatures. We assess the client’s existing systems, processes, and documentation to determine their alignment with regulatory standards, identifying any areas of non-compliance or potential gaps that may require remediation.
Collaborating closely with the client, we translate the findings from the regulatory compliance assessment into a customized CSV strategy tailored to their unique needs and organizational context.
Our team develops a detailed roadmap that outlines the sequential steps, milestones, and timeline for CSV implementation, ensuring clarity and accountability throughout the process.
The strategy encompasses elements such as risk-based approaches, resource allocation, and quality assurance measures.
We engage with stakeholders across different departments and levels of the organization to foster understanding, alignment, and commitment to the CSV strategy.
Through interactive workshops and seminars, we educate stakeholders on CSV principles, methodologies, and best practices, empowering them with the knowledge and skills required for effective implementation.
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.
