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Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Equipment Qualification – Execution

Zamann Pharma Support offers consultancy services to assist clients in executing Equipment Qualification activities when they lack the resources or expertise to do so independently. Our team ensures thorough execution of Qualification Protocols, testing, and documentation, adhering to regulatory standards and industry best practices

A person in a cleanroom suit working on machinery in a technology manufacturing facility.

Protocol Execution

We meticulously execute qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), following predefined procedures and acceptance criteria.

Our team performs equipment testing and verification activities to validate that the equipment meets specified requirements and functions as intended.

Test Result Documentation

Zamann meticulously documents test results, observations, and deviations encountered during the qualification process, ensuring thorough documentation of qualification activities.

We generate comprehensive reports summarizing the qualification findings, including any discrepancies or non-conformities identified during testing.

Compliance Verification

Our consultants verify compliance with regulatory requirements and industry standards throughout the qualification process, ensuring that all activities align with FDA, EMA, and other relevant guidelines.

We conduct thorough reviews of documentation and test data to confirm adherence to acceptance criteria and regulatory expectations, mitigating compliance risks for our clients.

Customized support for Qualification and Validation

We provide Qualification and Validation support, designed specifically to your facility and products, ensuring that each process is meticulously designed, documented, and verified. With our hands-on support, you can trust that your operations meet all regulatory standards

Why Zamann?

Zamann’s expertise in Qualification and Validation is rooted in industry best practices and rigorous global regulatory insight. Our team brings a thorough approach that secures compliance, improves reliability, and supports your facility’s operational success

Modern Laboratory Work Space

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