Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
We offer support for the execution of all activities related to Qualification and Validation routines, including Computerized Systems Validation, Equipment Qualification, Cleaning Validation, Process Validation, Validation of Water Systems.
Our team specializes in qualifying equipment to ensure its suitability for pharmaceutical manufacturing processes. We conduct thorough assessments, testing, and documentation to verify that equipment meets regulatory standards and operational requirements.
We offer end-to-end solutions regarding CSV, including document creation (according to GAMP5), test execution, third-parties management, access control, trainings, and data management. Our experts ensure that these systems meet regulatory requirements and industry standards, covering aspects such as data integrity, security, and functionality.
Support for Cleaning Validation activities to ensure that equipment and facilities are effectively cleaned and free from contamination. Our services include protocol development, and sampling plans, to demonstrate the effectiveness of cleaning processes.
Our team assists in Process Validation to ensure consistent product Quality and compliance with regulatory requirements. We develop validation protocols, and execute validation studies, to confirm the robustness and reliability of manufacturing processes.
We provide support related to strategy and document creation to Water Systems Validation, to ensure the quality and purity of water for various applications.
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