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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

TrackWise System – Holistic Implementation Support (CSV)

We offer support for the TrackWise implementation, focusing on Computer System Validation to ensure that all aspects of the process meet regulatory compliance and industry standards. Our expert team provides comprehensive guidance throughout the entire implementation lifecycle, from planning and requirements gathering to execution and validation, ensuring that the system is configured and deployed effectively.

Comprehensive Requirements Analysis

ZPS conducts an in-depth analysis of client requirements, facilitating workshops and interviews with stakeholders to gather essential information on business processes and regulatory needs. This analysis informs the development of a tailored implementation plan that addresses both functional and compliance requirements specific to the TrackWise System.

Validation Documentation Preparation

Our team prepares all necessary validation documentation, including User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and Validation Plans. These documents serve as a foundation for the validation process, ensuring that all system functionalities are well-defined and aligned with regulatory expectations.

Execution of Validation Testing and Support

ZPS oversees the execution of validation testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). We provide ongoing support throughout the testing phase, ensuring that all issues are identified and resolved promptly. Additionally, we facilitate training sessions for end-users to promote proper system usage and ensure compliance with operational protocols.

TrackWise System – Process Optimization

TrackWise System – Software Implementation

TrackWise System – Workflow Configuration and Customization

TrackWise System – Software Validation

TrackWise System – Master Data Management

TrackWise System – Version Upgrade Support

Nitrosamines – GAP Assessment regarding ICH M7

TrackWise System – Migration from On-Premise to Cloud (AWS) – ZPS Expertise

TrackWise System – Crystal Report Development

TrackWise System – WebServices Development

TrackWise System – Integration and Data Migration Projects

Tailored Solutions for Digital Transformation

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.

Why Zamann?

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.

Modern Laboratory Work Space

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