Many pharma and biotech manufacturers struggle to gain senior level buy-in for MES investments. Whilst corporate IT such as ERP is well understood, not believing in ROI for manufacturing solutions is a major reason why companies have difficulties to eliminate paper GxP records.
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OEE monitoring helps to identify weaknesses in production processes and select suitable optimization measures. Pharmaceutical manufacturers can thus increase the capacity of their existing plants while reducing costs.
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The acronym ALCOA+ has been around since the 1990’s, is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA+ relates to data, whether paper or electronic, and is defined by US FDA guidance as Attributable, Legible, Contemporaneous, Original and Accurate.
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To deliver Cell & Gene therapy treatments at scale bio-pharmaceutical companies are moving away from complex paper-based documentation, integrating many different electronic systems, and automating previously manual verification processes.
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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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