Activity
  • 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...
  • 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 industry team, shares some recent experiences on bridging these islands. I’m spending a lot of my time recently with both existing and potential customers…
  • 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 industry team, shares some recent experiences on bridging these islands. I’m spending a lot of my time recently with both existing and potential customers…
  • 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...
  • 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 Manufacturing Practices (cGMP) compliance into Electronic Batch Record (eBR) initiatives. Her discussion centered around three areas: eBR definition and ISA…
  • 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 Manufacturing Practices (cGMP) compliance into Electronic Batch Record (eBR) initiatives. Her discussion centered around three areas: eBR definition and ISA…
  • 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...
  • 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 philosophies into the upfront engineering, helps ensure consistent look and feel, and provides a visual medium to communicate designs to the project…
  • 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 philosophies into the upfront engineering, helps ensure consistent look and feel, and provides a visual medium to communicate designs to the project…
  • Fluidized Bed and Bin Blender PAT Applications

    In the early 2000s, a Wall Street Journal article, New Prescription For Drug Makers: Update the Plants, shared the news: The FDA [U.S. Food and Drug Administration] has concluded that the industry needs to adopt manufacturing innovations, partly to raise...
  • Fluidized Bed and Bin Blender PAT Applications

    In the early 2000s, a Wall Street Journal article, New Prescription For Drug Makers: Update the Plants , shared the news: The FDA [U.S. Food and Drug Administration] has concluded that the industry needs to adopt manufacturing innovations, partly to raise quality standards. The agency is overhauling its elaborate manufacturing regulations for the first time in 25 years. So over the past decade, the Life Sciences…
  • Fluidized Bed and Bin Blender PAT Applications

    In the early 2000s, a Wall Street Journal article, New Prescription For Drug Makers: Update the Plants , shared the news: The FDA [U.S. Food and Drug Administration] has concluded that the industry needs to adopt manufacturing innovations, partly to raise quality standards. The agency is overhauling its elaborate manufacturing regulations for the first time in 25 years. So over the past decade, the Life Sciences…
  • 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...
  • 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 gain competitive efficiencies, this integration also involves a great number of people and their associated work processes within the organization…
  • 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 gain competitive efficiencies, this integration also involves a great number of people and their associated work processes within the organization…
  • 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...
  • 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 Enterprise-Control System (IEC 62264) hierarchy. I caught up with Emerson’s Gary Mitchell , a member of the Life Sciences industry consulting team. Gary…
  • 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 Enterprise-Control System (IEC 62264) hierarchy. I caught up with Emerson’s Gary Mitchell , a member of the Life Sciences industry consulting team. Gary…
  • CPhI Pharma Evolution Guest Post-Electronic Batch Records: Are Your Systems Ready for Inspection?

    I wanted to share my guest post published at the CPhI Pharma Evolution website. There are some great comments, so join in if the post sparks some ideas. Stringent inspection-readiness policies are common with pharmaceutical and biotech manufacturers....
  • CPhI Pharma Evolution Guest Post-Electronic Batch Records: Are Your Systems Ready for Inspection?

    I wanted to share my guest post published at the CPhI Pharma Evolution website . There are some great comments , so join in if the post sparks some ideas. Stringent inspection-readiness policies are common with pharmaceutical and biotech manufacturers. From a computerized system standpoint, the rules of Part 11 (Electronic Records; Electronic Signatures – Scope and Application) and Good Automated Manufacturing Practice…
  • CPhI Pharma Evolution Guest Post-Electronic Batch Records: Are Your Systems Ready for Inspection?

    I wanted to share my guest post published at the CPhI Pharma Evolution website . There are some great comments , so join in if the post sparks some ideas. Stringent inspection-readiness policies are common with pharmaceutical and biotech manufacturers. From a computerized system standpoint, the rules of Part 11 (Electronic Records; Electronic Signatures – Scope and Application) and Good Automated Manufacturing Practice…
  • 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...
  • 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 how manufacturing processes are designed. Through modular, hybrid and off-the-shelf designs such as GE KUBio and the NNE Standard Facility, the speed…
  • 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 how manufacturing processes are designed. Through modular, hybrid and off-the-shelf designs such as GE KUBio and the NNE Standard Facility, the speed…
  • 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...