Posts Tagged ‘electronic batch record’

Moving to Electronic Batch Records

Posted in Life Sciences, Operations Management on Wednesday, May 30th, 2018. One comment so far
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Yesterday we highlighted advancements in exception management technology for pharmaceutical and biopharmaceutical manufacturers. Exception management is one element in an electronic batch record (EBR). Other elements for the EBR which also have high data integrity requirements include equipment management, material management and batch record process flow and recipe management. In a PharmTech article, Making the […]

Niche-Buster Medicine Information Solutions

Posted in Life Sciences, Operations Management on Wednesday, December 16th, 2015. No comments yet
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Author: Michalle Adkins We are seeing a trend in the life sciences industry moving away from blockbusters to niche busters, population based medicines and even to the extreme of personalized medicines. The Emerson Life Sciences consulting team recently had the opportunity to work with one of these emerging companies that is using a novel process […]

Electronic Batch Record Design Considerations

Posted in Life Sciences, Operations Management on Thursday, November 21st, 2013. 2 comments so far
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Last week, the 2nd International Summit on GMP, GCP & Quality Control was held in Chicago, Illinois USA. Emerson’s Heather Schwalje, a senior Life Sciences consultant, presented Moving beyond part 11; Quality assurance considerations for translating Current Good Manufacturing Practices (cGMP) compliance into Electronic Batch Record (eBR) initiatives. Her discussion centered around three areas: eBR […]

Aligning Stakeholders in Operations Management Projects

Posted in Life Sciences, Operations Management on Thursday, July 18th, 2013. 4 comments so far
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The ISA-95 (IEC 62264) Enterprise-Control System Integration (part 1, part 2, part 3, part 4, part 5) international standard provides a model to help define the boundaries between the enterprise systems and process control systems. As manufacturing operations seek to gain competitive efficiencies, this integration also involves a great number of people and their associated […]

Interphex Panel-Implementing Electronic Batch Records

Posted in Event, Life Sciences, Operations Management on Tuesday, April 23rd, 2013. No comments yet
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If you’re in the pharmaceutical and biotech industries, you likely know that Interphex takes place today through Thursday at the Javits Center in New York City. On Wednesday at 1:30-2:30pm in 1E10, Emerson’s Michalle Adkins will be leading a panel, Road Map to Implementing EBR [electronic batch records] #505. Here’s the description for this panel: […]