Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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We offer comprehensive support in executing Water Systems Validation activities, assisting clients in document creation, protocol development, risk assessment, sampling, process adherence, and reporting, to ensure compliance with regulatory requirements. Our team oversees the entire validation process, from planning to implementation, providing expertise and guidance every step of the way.
We collaborate to develop robust validation protocols customized to their specific water systems, including WFI, PW, and Pure Steam. Our experts outline clear procedures, acceptance criteria, sampling plans, and testing parameters to ensure thorough validation of system performance and integrity. By crafting detailed protocols in alignment with regulatory expectations, we lay the groundwork for effective validation execution and compliance assurance.
Our team conducts comprehensive risk assessments to identify potential hazards, vulnerabilities, and critical control points within water systems. Through systematic evaluation, we prioritize risks associated with system design, operation, maintenance, and microbial control to mitigate potential quality and safety issues. By integrating risk mitigation strategies into the validation process, we enhance system reliability and minimize the likelihood of product contamination or quality deviations.
We oversee the execution of validation activities, including sampling, testing, system performance evaluation, and documentation of results.
Our experts ensure adherence to established protocols, regulatory requirements, and industry best practices throughout the validation process. Upon completion, we compile comprehensive validation reports detailing all findings, observations, and conclusions, providing clients with a clear overview of validation outcomes and compliance status.
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
