Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Our expert consultants conduct the necessary Periodic Reviews of validated computerized systems to ensure ongoing compliance with regulatory requirements and industry standards. We assist clients in maintaining the integrity, reliability, and security of their systems through regular assessments and updates.
We conduct a detailed examination of relevant changes made (directly and indirectly) to the computerized system since the last review cycle, including software updates, configuration modifications, data migrations, and other alterations impacting system functionality or regulatory compliance. Our team assesses the impact of changes on validation status, ensuring that appropriate validation activities are executed to maintain CSV status.
Our experts evaluate the qualification status of the IT infrastructure supporting the computerized system. This involves reviewing qualification documents related to servers, networks, databases, and other infrastructure components. We verify compliance with regulatory requirements, assess the effectiveness of qualification activities, and identify any GAPs or deficiencies requiring corrective action to uphold system reliability and compliance.
Comprehensive assessment of suppliers and service providers associated with the computerized system (e.g.: software vendors, hardware suppliers, maintenance providers). Our evaluation encompasses supplier qualification status, adherence to contractual agreements, responsiveness to corrective actions, and overall quality of products or services delivered.
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.
