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...
electronic batch record
Niche-Buster Medicine Information Solutions
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...
Electronic Batch Record Design Considerations
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...
Aligning Stakeholders in Operations Management Projects
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...
Interphex Panel-Implementing Electronic Batch Records
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...
Mistake Proofing Pharmaceutical Production and Documentation Processes
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...
Continuous Process Verification per FDA Process Validation Guidance
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....
Planning an Electronic Document Management Project
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...
Paperless, Release by Exception Electronic Workflows
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...
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The opinions expressed here are the personal opinions of the authors. Content published here is not read or approved by Emerson before it is posted and does not necessarily represent the views and opinions of Emerson.