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Equipment Qualification – GAP Assessment

Consultancy services to assess clients’ existing processes related to Equipment Qualification. Our focus is on evaluating SOPs, records, executed qualifications, trainings, and more, to ensure compliance with international references such as FDA and EMA guidelines. Through meticulous assessment, we identify potential GAPs in the Qualification process and provide recommendations for improvement.

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Documentation Review

We conduct a comprehensive review of clients’ SOPs, records, and documentation related to equipment qualification to assess compliance with regulatory requirements.

Our team evaluates the adequacy and completeness of documents, identifying any GAPs or inconsistencies that may impact compliance.

Qualification Process Evaluation

Zamann assesses the execution of equipment qualification activities, including protocol development, execution, and reporting, to ensure adherence to established procedures and standards.

We review Qualification reports and documentation to verify that all required tests and assessments have been conducted as per regulatory expectations.

Training and Competency Assessment

Our consultancy service includes an evaluation of training programs and staff competency related to Equipment Qualification processes.

We assess the effectiveness of training materials and programs in equipping personnel with the necessary knowledge and skills to perform qualification activities effectively and in compliance with regulations.

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

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