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Posts Tagged ‘electronic batch record’

Mistake Proofing Pharmaceutical Production and Documentation Processes

Posted in Life Sciences, Operations Management on Wednesday, February 29th, 2012. 3 comments so far
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As a follow up to the post, Using Operational Excellence Techniques to Understand and Solve Business Problems, Emerson’s Michalle Adkins shared a great story of one pharmaceutical manufacturer’s path to justify technology to help their business objective to reduce deviations, eliminate redundant work, and improve production efficiency, including the product release process. The current method […]

Continuous Process Verification per FDA Process Validation Guidance

Posted in Life Sciences, Operations Management on Thursday, January 19th, 2012. 10 comments so far
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It was just about a year ago that the U.S. Food and Drug Administration published their Guidance for Industry – Process Validation: General Principles and Practices. I caught up with Emerson’s Heather Schwalje, a senior consultant on the Life Sciences industry team. Heather shared key elements from this FDA process validation guidance document and how […]

Planning an Electronic Document Management Project

Posted in Life Sciences, Operations Management on Monday, March 28th, 2011. No comments yet
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It’s great that Tim Alosi, from Emerson local business partner, New England Controls, was in town this past week. He saw the recent post, Shrinking Batch Record Creation Time and Document Management Complexity. Repligen is one of New England Controls customers, and Tim had more to share on this story. The New England Controls team […]

Paperless, Release by Exception Electronic Workflows

Posted in Operations Management on Thursday, March 11th, 2010. No comments yet
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If your current work processes are causing delays in getting your manufactured products released for sale, you may want to catch Christie Deitz‘, Electronic Workflow for a Bioreactor presentation. She’ll be co-presenting with an automation engineer from a leading pharmaceutical manufacturer at the 2010 World Batch Forum North American Conference, which will be held May […]