Pharmaceutical and biotech manufacturers seek to improve both project and operational performance through implementation of smart factory technology. The smart factory fits right into the S95 enterprise automation model and provides out-of-box manufacturing...
ISA-95
Optimizing Life Sciences Processes by Improving Data Integration
Pharmaceutical and biotech manufacturers face many economic and technical challenges including reduced prices and diminishing profits, rising research & development costs, increasing regulatory requirements and a greater need for optimized manufacturing...
Data Integrity for Compliance, Audit Readiness and Performance
Pharmaceutical and biotech manufacturers have stringent regulatory compliance requirements. These requirements must balance with the need for improvement and optimization to run safely, efficiently, profitably and in line with the business and quality objectives. In a...
Advancing the Management of Data through Life Sciences Product Lifecycles
From a recent Life Sciences symposium, we looked at issues in the advancement of process intelligence and analytics. Today we'll look at another work session from the symposium, Managing Data Through the Product Life Cycle. The general session was led by Amgen's...
Successfully Automating Terminal Operations
Making an operational step change in a production process involves a clear vision and people, processes and tools to execute the vision. A July/August 2014 Tank Storage magazine article, Automating terminal operations, highlights the story of Vopak transforming their...
Enabling Release by Exception Manufacturing
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...
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...
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...
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...
Interfaces to Consider for Manufacturing Execution System (MES) Projects
Projects to connect your process operations to your business processes and workflows typically require connections with several specialized software platforms. For manufacturers in the pharmaceutical and biotech industries, these electronic connections span the ISA-95...
Automated, Integrated, and Improved Terminal Operations
Tank storage facilities are critical in the supply chain from feedstock production through mid-stream and end user distribution. At last summer's Emerson Exchange Düsseldorf conference, Vopak's Louis Janssen and Emerson's Cor Vermeijs presented, Improved terminal...
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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.