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 offers consultancy services in Labware LIMS – System Validation (Implementation), covering end-to-end Computer System Validation (CSV) services aligned with regulatory requirements (e.g., FDA, EMA) and GAMP5 guidelines. This included the creation of validation strategies, execution of qualification protocols, and documentation review to ensure the LIMS implementation complied with industry standards. The consultancy enabled the organization to achieve a validated system that ensured data integrity, reliability, and compliance
Development of a comprehensive Validation Master Plan (VMP) aligned with Labware LIMS necessities, including the validation deliverables, risk assessments, and a timeline aligned with regulatory expectations. Creation, review and approval of all required CSV documents (e.g., URS, FRS, IQ, OQ, PQ protocols).
Coordination and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols to confirm that the Labware LIMS met design specifications, operated as intended, and supported the company’s business needs.
Performing a detailed GAP analysis to evaluate the system’s alignment with FDA 21 CFR Part 11, EU Annex 11, and other regulatory requirements, identifying compliance risks and providing specific recommendations to mitigate GAPs, ensuring robust data integrity and regulatory adherence.
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.
