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 specialized consultancy services for the validation of TrackWise, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11, EMA Annex 11, and GAMP5. Our validation process guarantees that the system operates as intended, maintains data integrity, and meets all functional, security, and performance requirements. We provide end-to-end validation support, including planning, documentation, testing, and ongoing maintenance to keep the system in a validated state
We develop a comprehensive Validation Master Plan (VMP) and perform risk assessments to define the validation scope, strategy, and critical parameters. This ensures a risk-based approach aligned with regulatory expectations and business needs, minimizing compliance risks.
Our experts create and execute key validation documents, including User Requirements Specification (URS), Functional Specification (FS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Each test script is meticulously designed to verify system functionality and compliance with predefined acceptance criteria.
We establish a continuous validation strategy by reviewing change controls, performing periodic revalidations, and assessing the impact of software updates. This ensures that TrackWise remains in a validated state throughout its lifecycle while maintaining alignment with evolving regulatory requirements.
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.
