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On-demand webinar: From Paper to Paperless – Tackling the 21CFR11 Challenge
Using the example of a standard Data Management implementation.
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Data integrity
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Article: Data integrity – Metrohm software products make compliance easy
Data integrity requires data to be complete, consistent, and accurate throughout their complete lifecycle, providing full transparency and traceability. Industry guidelines such as ALCOA and ALCOA+ describe these requirements, which are used by the FDA, WHO, PIC/S and GAMP. All major Metrohm software products make compliance with the ALCOA and…
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CEO of Novartis pledges to speed data integrity disclosures
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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Expert View: Data integrity in the QC micro laboratory
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.
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OTC drug manufacturer receives warning letter for data integrity issues
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
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Application note: PharmaIntegrityTM – Cleanroom Data Management System
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.
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Clinical trial sponsors called to publish results on EU database
All sponsors of clinical trials conducted in the European Union have been reminded of their obligation to make summaries of trial results.
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Guide to Informatics & Data Integrity
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.
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ACD/Labs: empowering data-driven decisions
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…
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Data integrity for cleanroom monitoring
With a continual focus on data integrity and helping our customers meet regulations while generating actionable insights, Particle Measuring Systems provides a complete range of products and services.
