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Posts Tagged ‘ISA-95’

Enabling Release by Exception Manufacturing

Posted in Emerson Exchange, Life Sciences on Thursday, September 11th, 2014. 2 comments so far
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The Emerson Exchange conference October 6-10 in Orlando, Florida USA is rapidly approaching. I caught up with Emerson’s Michalle Adkins who mentioned that her team of Life Sciences consultants would be highlighting the enablement of release by exception. Although release by exception and real-time release are not yet a reality for the majority of pharmaceutical […]

Improving Technology Transfer by Earlier Adoption of Standards and Software Platforms

Posted in Life Sciences, Operations Management on Thursday, August 21st, 2014. 2 comments so far
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In 2011, the U.S. Food & Drug Administration (FDA) published their Guidance for Industry – Process Validation: General Principles and Practices. A PharmManufacturing.com article, A Framework for Technology Transfer to Satisfy the Requirements of the New Process Validation Guidance: Part 2 shared the impact on the Life Sciences industry: In the life of any drug […]

Bridging Islands of Automation

Posted in Life Sciences, Operations Management on Thursday, December 5th, 2013. 2 comments so far
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While integration technologies have helped bridge “islands of automation” over the years, some process manufacturers still have parts of their automated processes disconnected from the rest. Emerson’s Gary Mitchell, a senior industry consultant on the Life Sciences industry team, shares some recent experiences on bridging these islands. I’m spending a lot of my time recently […]

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 […]