Posts Tagged ‘21 CFR Part 11’

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 […]

Integrated Biometric Authentication in Electronic Records

Posted in Life Sciences, Operations Management on Thursday, August 4th, 2016. No comments yet
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How many of you have more passwords than you can possibly remember? Count me in with the affirmatives. Biometric authentication is one way to overcome this large and growing problem. For process manufacturers and producers, especially those in highly regulated industries such as pharmaceutical and biopharmaceutical manufacturing, authenticated actions also need to be recorded to […]

Implementing Quality by Design

Posted in Life Sciences on Thursday, February 20th, 2014. 2 comments so far
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Many manufacturers in the Life Sciences industry are challenged to respond to a new paradigm for process development and manufacturing. The FDA’s cGMP for the 21st Century initiative is driving the industry to change its development and manufacturing to be based on process understanding and a risk based approach. This new paradigm uses terminology such […]

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 […]

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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 […]

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