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At Zamann Pharma Support GmbH, we offer expert consultancy services specializing in comprehensive equipment qualification gap assessment activities. Our focus is on evaluating existing processes, SOPs, qualification records, executed protocols, and training programs to verify compliance with international standards such as FDA and EMA guidelines. Through detailed assessments, we systematically identify potential compliance gaps, inconsistencies, and process weaknesses in the qualification framework. By delivering actionable recommendations for improvement, we help pharmaceutical companies enhance their qualification systems, reduce regulatory risks, and ensure their equipment qualification processes align fully with the latest regulatory expectations and industry best practices.
As part of our equipment qualification gap assessment services, Zamann Pharma Support conducts an exhaustive review of all client documentation related to equipment qualification. We examine SOPs, executed records, validation protocols, maintenance logs, and qualification reports to assess their adequacy, completeness, and compliance with regulatory requirements. Our team identifies any missing elements, inconsistencies, or outdated practices that could compromise qualification integrity or audit readiness. By providing structured feedback and practical corrective actions, we help clients improve documentation quality, reinforce traceability, and maintain robust compliance frameworks that withstand regulatory scrutiny during inspections and quality system audits.
Our equipment qualification gap assessment includes an in-depth evaluation of the entire qualification process to ensure operational and regulatory compliance. Zamann Pharma Support reviews protocol development, testing execution, deviation management, and final reporting practices. We assess whether protocols were developed following risk-based principles, executed correctly, and documented thoroughly in accordance with FDA, EMA, and GAMP5 standards. We also verify that acceptance criteria were defined and applied properly. By highlighting gaps in procedural adherence or documentation quality, we support the optimization of qualification activities and help organizations build stronger, audit-proof equipment validation programs.
Training and personnel competency are critical to successful equipment qualification, and our gap assessment services include a thorough evaluation of these areas. Zamann Pharma Support reviews client training programs, competency matrices, and qualification-specific training materials to ensure they meet regulatory expectations. We assess the effectiveness of training sessions in equipping employees with the knowledge and skills needed to perform qualification activities accurately and compliantly. Where gaps exist, we provide recommendations for enhancing training content, delivery methods, and documentation practices, helping clients foster a culture of continuous improvement, competence assurance, and sustained regulatory compliance.
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
