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 EMA will be delaying the roll-out of the new ISO IDMP (Identification of Medicinal Products) standard within Europe until[…]
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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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