According to the FDA (“Data Integrity and Compliance with CGMP Guidance for Industry”), data integrity refers to the completeness, consistency, and accuracy of data. In the last years, the FDA has seen an increase in data integrity violations.
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The rapid adoption of new technologies , such as Mobile, Internet of Things (IoT), Advanced Analytics or Cloud, will impact healthcare significantly!
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Imagine you are an up and coming cell therapy company. You have gone through the exploration phase, with all of its complexities and are in the process of finalizing a breakthrough treatment.
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The terms ‘Internet of Things (IoT)’ and ‘Industry 4.0’ reference technology-driven initiatives that have begun to disrupt traditional manufacturing methods,[…]
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Ensuring the quality of MBR design is critical to successful MES, and, as such, the end-goal of creating high-quality MBRs[…]
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Master Batch Records (MBRs), which are general manufacturing instructions, are a critical piece of manufacturing execution systems (MES). They provide[…]
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Are we finally getting used to the dramatic new technological innovations changing and improving our everyday lives? Such trends have[…]
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In the pharma manufacturing IT space, Industry 4.0 has been a growing theme that has driven our direction in the[…]
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The global pharmaceutical industry is known for its ability to reinvent itself. The industry is renowned for its innovations across[…]
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On behalf of the ISPE Special Interest Group (SIG) “Pharma 4.0 and Holistic Manufacturing Control Strategy”, join us to attend[…]
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