Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Support in executing a hands-on assistance to ensure thorough review processes, compliance with regulatory standards, and timely identification of any discrepancies or deviations. By leveraging our expertise, companies can enhance the Quality and integrity of their Batch Records, contributing to overall product quality and regulatory compliance.
Our team meticulously verifies the accuracy and completeness of batch records, cross-referencing information against approved procedures, specifications, and regulatory guidelines. We ensure that all data entries are correct, legible, and properly documented, minimizing the risk of errors and noncompliance.
We conduct comprehensive assessments of batch records to ensure compliance with GMP regulations and industry standards. Our experts evaluate adherence to documented procedures, regulatory requirements, and internal quality standards, identifying areas for improvement and implementing corrective actions as necessary.
Our Batch Record Review service includes an assessment of data integrity and quality assurance measures. We scrutinize data entries for consistency, accuracy, and traceability, ensuring that critical manufacturing processes are properly documented and recorded. Additionally, we provide recommendations for enhancing data integrity controls and implementing best practices for batch record management.
Our team collaborates closely with you to create, maintain and improve your Quality Management Systems ensuring a perfect fit between processes and goals. From initial setup to ongoing support, we ensure that every element supports robust holistic compliance, efficiency, and long-term growth.
Zamann is committed to building Quality Management Systems that exceed expectations. With a deep understanding of regulatory requirements and global practical expertise, we ensure not only compliance with regulations, but also optimization of QMS´s workflows and continuous improvement.
