The ANSI/ISA-95 standard defines models for the information flows between the instrumentation and automation layers up to the enterprise information layers for process manufacturers and producers. Moving up the levels increases the need for people, processes and...
manufacturing execution system
Improving Technology Transfer by Earlier Adoption of Standards and Software Platforms
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...
Integrated Data Management throughout Drug Development Phases
This week, the Bio International Convention (Bio 2014) is happening in San Diego, California. Several of Emerson's Life Sciences consultants, including Zuwei Jin, are there to discuss some of the issues and trends in pharmaceutical and biotech manufacturing processes...
Optimizing Formulation, Fill and Finish Manufacturing Facilities
Pharmaceutical and biotech manufacturing processes are complex and require well integrated and documented flows of information from upfront forecast demand and customer orders through the production process to inventory receipt and order fulfillment. The components...
Planning Process for Life Science Optimization Projects
For many process manufacturers with lean engineering staffs, partnering with outside automation specialists is critical for successful automation and optimization projects. Emerson's Michalle Adkins, who leads the Life Sciences Industry Solutions consulting team,...
Bridging Islands of Automation
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...
Prototyping Key in Manufacturing Execution System Projects
In an earlier post, Five Strategies for Mitigating Automation Project Risk, we highlighted the importance of prototyping: Risks in budget, schedule, changes, and project execution can be reduced with a prototyping strategy. Prototyping helps incorporate operational...
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...
Impact of Single Use Technologies on Automation and Information Management
One of the conversations happening among pharmaceutical and biotech manufacturers is around the "facility of the future". I caught up with Emerson's Gary Mitchell, a consultant on the Life Sciences industry team. He shared some of the trends prompting this relook at...
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...
Trends in Process Analytical Technology and Quality by Design
At the recent conference for pharmaceutical and biotech manufacturers, Interphex 2012, Pharmaceutical Manufacturing magazine Editor in Chief Agnes Shanley discussed trends in the industry's use of process analytical technology (PAT) and quality by design (QbD) with...
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...
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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.