Archive for the ‘Life Sciences’ Category

Data Integrity for Pharmaceutical and Biotech Manufacturers

Posted in Life Sciences, Regulatory Compliance on Tuesday, March 13th, 2018. No comments yet
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Update: This post has been updated with a link to the most recent Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions – March 2018 document. For pharmaceutical, biotech and other manufacturers in highly-regulated industries, the production data is as important as the product itself for release to sale. Data integrity […]

Identify and Resolve Cell Therapy Batch Manufacturing Exceptions

Posted in Life Sciences, Operations Management on Tuesday, February 20th, 2018. No comments yet
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We conclude our series on improving cell therapy manufacturing with a closer look at the review by exception process. In the manufacturing process of cell therapeutics, product cycle times are extremely short and any exceptions occurring during the production process must be found and addressed quickly. Emerson’s Bob Schiros notes that manufacturing execution systems, such […]

Increasing Autoclave Reliability via Machine Learning Technology

Posted in Life Sciences on Tuesday, February 13th, 2018. No comments yet
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ARC Advisory Group’s Paula Hollywood moderated a session, IT/OT/ET Convergence at the 2018 ARC Industry Forum. Here’s the description from this session: The convergence of IT (Information Technology at the enterprise level) and OT (Operations Technology, the information and automation technologies employed in the plant), is not new, but the relationship is intensifying. What is […]

Designing and Building Pharmaceutical and Biotech Smart Factories

Posted in Life Sciences, Operations Management on Wednesday, February 7th, 2018. No comments yet
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Pharmaceutical and biotech manufacturers seek to improve both project and operational performance through implementation of smart factory technology. The smart factory fits right into the S95 enterprise automation model and provides out-of-box manufacturing functionality representing the best practice in the industry and complying with the regulation such as cGMP. The smart factory technology connects the […]

Digital Transformation to Paperless Production

Posted in Life Sciences, Operations Management on Friday, February 2nd, 2018. No comments yet
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Manufacturing processes have long been paper-based with log entries, initialing, signoffs and other transactions to manually record. While automation systems have captured some of this manual recordkeeping, they have not been able to capture everything. In batch manufacturing processes that produce thousands of batches each year, maintaining paper records for each batch is a time-consuming, […]