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At Zamann Pharma Support GmbH, we offer specialized consultancy services to assist clients in executing equipment qualification activities efficiently and professionally. When internal resources or expertise are limited, our team steps in to provide comprehensive execution support, ensuring all qualification tasks are performed in strict alignment with regulatory requirements and industry best practices. From protocol execution to testing and documentation, we manage the entire process systematically. Our structured approach guarantees the equipment meets defined specifications and regulatory expectations, reducing operational risks and reinforcing product quality and compliance throughout every stage of your equipment qualification project.
Successful equipment qualification hinges on the precise execution of well-structured protocols, and our team excels in delivering this critical phase. We meticulously execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities following predefined acceptance criteria and procedures. Our consultants perform detailed equipment testing, calibration verifications, and operational assessments to validate that the equipment operates according to the intended use. By ensuring each protocol step is executed consistently and documented carefully, we help clients maintain compliance, enhance traceability, and ensure that every piece of equipment supports safe, efficient pharmaceutical manufacturing operations.
Accurate documentation is at the heart of every successful equipment qualification process, and at Zamann, we approach this task with unmatched precision. Our team meticulously records test results, observations, anomalies, and any deviations encountered during the execution of qualification protocols. We generate detailed and structured reports that summarize findings, highlight discrepancies, and outline corrective actions where necessary. Every document is designed to provide full traceability and ensure regulatory audit readiness. By delivering comprehensive and clear test result documentation, we help clients build strong qualification records that support long-term operational excellence and compliance assurance.
Ensuring regulatory compliance is a non-negotiable aspect of equipment qualification, and Zamann Pharma Support GmbH ensures this objective is fully achieved. Throughout every phase of qualification activities, we verify that all procedures, testing, and documentation align with regulatory expectations from agencies like the FDA, EMA, and others. Our consultants review qualification protocols, execution results, and documentation thoroughly to confirm adherence to predefined acceptance criteria and industry guidelines. By integrating compliance verification into every stage of the qualification process, we mitigate risks, strengthen audit preparedness, and ensure your equipment remains fit for use in regulated environments.
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
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
