Novartis reportedly knew of discrepancies in the Zolgensma data it had submitted to the FDA but delayed informing regulators so has announced alterations to its processes.
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The quality control (QC) microbiology laboratory plays an essential role in pharmaceutical manufacturing and product release. Jessica Rayser discusses the importance of data integrity to ensure safe and effective products are manufactured.
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
PharmaIntegrity™ is the definitive solution for managing the collection, analysis, and trending of environmental monitoring data, ensuring timely detection of problems in production, facilitating product release and reducing risks and costs associated with product loss and recalls.
All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.
In this edition, two companies showcase their services and highlight how they stand out from the crowd. The exponential speed of the information technology evolution is rapidly being accepted and integrated into our everyday life, yet it remains a challenge in the laboratory.
ACD/Labs helps scientific R&D organisations assemble digitised analytical, structural and molecular information for effective decision-making, problem solving and product lifecycle control by their scientists. Their enterprise technologies enable automation of molecular characterisation and product development, and facilitate chemically intelligent knowledge management, data analytics and collaboration – both within organisations and…