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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Computerized Systems Validation – Routine Support

Our CSV Support service is designed to comprehensively address the complexities of Computerized Systems Validation through careful planning, execution, and documentation of all validation activities. This vital service includes the development and maintenance of thorough validation master plans, specific protocols, and detailed reports. Additionally, we monitor all system changes throughout their lifecycle to ensure that any modifications are documented and assessed. Our support also extends to assessing the impact of these changes on validation statuses and maintaining updated validation documentation, ensuring that our clients remain compliant with essential regulations and industry best practices.

Comprehensive CSV Support services for effective management of Computerized Systems Validation, ensuring planning, execution, documentation, and ongoing compliance with industry standards.

Validation Lifecycle Execution

In our CSV Support services, we provide specialized assistance in managing the complete validation lifecycle of computerized systems. Our focus is on the structured planning, precise execution, and thorough documentation of all validation activities, which includes developing and maintaining validation master plans, protocols, and comprehensive reports. We also prioritize tracking and managing changes and updates to systems throughout their lifecycle, ensuring that every modification is assessed for its impact on the overall validation status. This rigorous oversight allows us to support our clients in maintaining compliance with all relevant industry standards and regulatory requirements.

Change Control Support

Our CSV Support service extends to providing essential assistance in managing changes to computerized systems effectively. We focus on assessing the impact of these changes on existing validation statuses to ensure that any potential risks are identified early. Our team ensures that all necessary validation documentation is updated promptly, reflecting any alterations made to the systems. Furthermore, we assist in implementing robust change control procedures designed to maintain system integrity and compliance with all applicable regulatory requirements. By facilitating a disciplined approach to change management, we help organizations uphold the highest standards of validation practices.

Computerized Systems Validation – Routine Support

Ongoing Validation Maintenance

As part of our comprehensive CSV Support, we conduct regular periodic reviews and thorough assessments of validated systems. These initiatives ensure that our clients achieve ongoing compliance with all regulatory requirements as well as alignment with industry best practices. Our process consists of conducting systematic system reviews, performing data integrity checks, and carrying out detailed audits to identify any potential validation gaps or deficiencies. By addressing these issues proactively, we help organizations not only maintain compliance but also enhance confidence in their validated systems, ultimately contributing to safer and more reliable operations.

CSV execution support for pharmaceutical industry by Zamann Pharma Support GmbH

Computerized Systems Validation – Execution

Evaluating suppliers during comprehensive CSV periodic review assessments.

Computerized Systems Validation – Periodic Review Execution

Audit trail review for computerized systems validation ensuring compliance with FDA regulatory standards.

Computerized Systems Validation – Audit Trail Review Execution

Waters Empower System implementation support for chromatography data management

Waters Empower System – Routine Support

Expert support for eQMS system implementation and integration.

e-QMS System
– Routine Support

Zamann Pharma Support's workshops and training programs enhance skills in computerized systems validation for professionals.

Computerized Systems Validation – Workshop and Trainings

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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