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Topic: Process Control Software
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Accessing Plant-Floor Intelligence |
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White Papers: In depth research
| Title | Author | Date |
| Overall Labor Effectiveness (OLE) Achieving a Highly Effective Workforce | Kronos Inc. | 04/25/2008 |
| Help your manufacturing business increase productivity and profitability through Overall Labor Effectiveness (OLE), a Kronos-developed key performance indicator that measures your workforce. As a companion to OEE (Overall Equipment Effectiveness), OLE gives your company the ability to analyze the impact of direct and indirect workforce output so that you can take action to reduce costs and to identify productivity opportunities. | ||
| Multivariate Calibration: A Science-Based Method | Ralf Marbach, VTT Optical Instruments Center | 12/06/2006 |
| A new method for multivariate calibration is less costly to implement than standard PLS or PCR methods, and eliminates the need to introduce additional variability into an otherwise stable process. It also allows specific responses to be proven from first principles. | ||
| From Procedural to Risk-Based Compliance and Enforcement | John Blanchard, ARC Advisory Group | 10/30/2006 |
| In this presentation, ARC analyst John Blanchard outlines the steps required for moving from the old to the new model, and what they mean for pharmaceutical manufacturers and the FDA. | ||
| Case Study: Hungarian Pharma Co. Revamps Digital Plant Architecture | Emerson Process Management | 03/08/2006 |
| When Gedeon Richter Ltd. set out to automate the tank farm at its main manufacturing facility, the company sought out a vendor that offered not only process knowledge, but also compliance and validation awareness and ongoing performance assurance. | ||
| Using PAT to Optimize Cell Culture for Monoclonal Antibody Development | Ache Stokelman et al., Amgen Inc. and BioProcessors Corp. | 12/05/2005 |
| Ache Stokelman and colleagues on Amgen’s Global Process Science Team outline how they used BioProcessors Corp.’s SimCell platform to improve results. | ||
| On-Line Alarm Auditing: A Tool for Greater Efficiency | Brian Gibson, P. Eng., Machine Automation, Inc. | 11/08/2005 |
| The right alarm auditing tool can tell you where opportunities for improvement are, and what the payback might be, explains Machine Automation, Inc.’s Brian Gibson. | ||
| Monitor Fermentation O2 and CO2 in Real Time | Tim Wilkes, Servomex, Inc. | 10/31/2005 |
| Keeping tabs on oxygen and carbon dioxide content in bioprocesses is critical for safety and contamination control, while comparing measurements against process models can help optimize yields and efficiencies, explains Tim Wilkes of Servomex, Inc. | ||
| MVA Modeling without Tears | Robin Brooks, Curvaceous Software | 09/30/2005 |
| So your operators wouldn’t know a differential from a quadratic equation? Curvaceous Software’s C:Suite Process Modeler uses geometric process control to handle quality control, process control and alarm management. Founder Robin Brooks and his colleagues discuss how it works, in an article originally published by IEEE. | ||
| PAT and Pharma Competence | Siemens AG | 09/30/2005 |
| This Guide to Process Analytical Technology analyzes the industry’s needs and discusses Siemens' multidisciplinary approach to meeting them. | ||
| How the Other Side Lives: FDA’s Experience with Enterprise IT | WhiteHouse.gov | 09/23/2005 |
| Has your company moved to new enterprise architecture software? Well, so has FDA. Read this quick report and compare your strategy, challenges and experiences with those of the Agency. | ||
| ERP and Lessons to Be Learned | A. Agarwal, H.T. Le and N. Kumar | 08/25/2005 |
| In the late 1990s, the drug distribution firm FoxMeyer sued its ERP vendor and implementation specialist, Arthur Andersen, claiming that its ERP installation had driven it into bankruptcy. In this discussion at the University of Singapore, experts dissect the case and lessons that drug companies can learn from it when installing ERP systems. | ||
| How MES Enables PAT | Joseph Vinhais, RAC, Camstar Systems, Inc. | 07/29/2005 |
| A Manufacturing Execution System provides a framework for PAT, allowing for enhanced productivity and quality, says Joseph Vinhais, vice president of regulatory compliance at Camstar Systems. | ||
| Experiment Design: The Medical Device Industry’s Lessons for Pharma | Ronald D. Fritz, president, InSite Technologies | 06/30/2005 |
| W.L. Gore’s Medical Product Division took an uncompromising approach to improving an underachieving process, and, using DOE and statistical process control techniques, turned it around. The drug industry can learn much from this story, writes Ronald D. Fritz, president of InSite Technologies. | ||
| Moving Pharmaceutical Manufacturing from Art to Science | IBM Business Consulting Services | 06/02/2005 |
| This white paper from IBM Business Consulting Services outlines the initiatives that will guide pharmaceutical manufacturing’s evolution. | ||
| Roadmap to Operational Excellence | Putman Custom Publishing | 05/26/2005 |
| In this special guide for pharmaceutical manufacturing professionals, Emerson Process Management outlines best practices you can use to create a culture of continuous improvement and achieve operational excellence within your operation. Download to learn more about the process, as well as the technology, training and consulting services Emerson offers to help you advance OpX at your facility. | ||
| Taming the Data Monster: Practical Guidance on Implementing PAT | Automsoft | 04/29/2005 |
| A new applications document from Automsoft summarizes the IT requirements for PAT, focusing on data management issues. | ||
| Software-Based Validation of Processing Systems Following 21 CFR 11 | Siemens | 04/29/2005 |
| This technical applications article discusses the implications of 21 CFR Part 11 and how Siemens Simatic HMI can be used to facilitate validation. | ||
| Use Drug Development Data More Intelligently | Michael Eckstut and Sam Venugopal, Conformia | 04/21/2005 |
| FDA’s Critical Path initiative outlines ways to bring more efficiency to the drug development process. The key to better knowledge management during this critical period is utilizing data more intelligently. Michael Eckstut and Sam Venugopal of the IT firm Conformia outline the challenges and potential solutions in this 7-page PDF document. | ||
| Track and Trace in the Cold Chain | Sensitech | 04/14/2005 |
| Active RFID tags with temperature capabilities are one way to give cold chain products special attention. | ||
| Don't Overlook Legal and Privacy Issues Posed by RFID | Ronald E. Quirk, Jr. and Stacia J. Borrello, Venable | 02/09/2005 |
| RFID poses serious legal and regulatory issues to manufacturers and plant owners. In this new white paper, former FCC senior attorney Ronald E. Quirk, Jr. and Stacia J. Borrello, both of whom work for the regulatory legal firm Venable, outline the legal complications of RFID and an electronic drug pedigree. | ||
| Paperless Calibration: Avoid an Avalanche of Paper | Prime Technologies | 02/03/2005 |
| A computerized system from Prime Technologies has helped Schering-Plough avoid an avalanche of paper. | ||
| Application Note: Control of Fermentation Processes | Ametek Process Instruments | 01/26/2005 |
| This application note from Ametek Process Instruments discusses traditional approaches to fermentation process control, and how the company's process mass spectrometer can be effectively applied. | ||
| Software-based Validation of Processing Systems | 01/19/2005 | |
| The Role of SCADA in Securing Our Critical Infrastructure | ControlGlobal.com | 01/19/2005 |
| Conducting routine self-assessments and scenario planning can help utilities identify security risks and develop counter measures before incidents occur. This 4-page PDF document from Control Microsystems explains how. | ||
| The Business Case for PAT | Rockwell Automation | 11/24/2004 |
| Having trouble justifying PAT projects to top management? The business drivers for PAT are compelling, both on the regulatory and on the financial side. This Rockwell Automation white paper discusses how to conduct a “productivity improvement appraisal” and how to handle discovery and analysis phases of any PAT project. | ||
| RFID in Manufacturing: Mandated Supply Chain Monitoring | 10/29/2004 | |
| Pharma 2010: Silicon Reality | IBM Business Consulting | 10/22/2004 |
| If the pharmaceutical industry is to capitalize on its greater understanding of molecular science and disease, it will have to invest in the right tools. This forward-looking report, part of the Pharma 2010 series by IBM Business Consulting, details seven key emerging technologies, from predictive biosimulation to advanced storage solutions, that will drive life sciences innovation in the next decade. | ||
| Case Study: Biotage Centralizes and Controls IT Management | 10/21/2004 | |
| Implementing a Global 21 CFR Part 11-Compliant CAPA System | 10/20/2004 | |
| Standards for Pharmaceutical Applications of PAT | Don Marlowe, FDA Standards Coordinator, Office of the Commissioner | 10/20/2004 |
| This presentation by Don Marlowe, FDA Standards Coordinator in the Office of the Commissioner, outlines the ASTM E-55 Committee's efforts in developing PAT standards for pharmaceutical applications. | ||
| Increase Productivity with an Integrated Software Framework for Measurement and Automation | 10/19/2004 | |
| Operational Solutions through Integrated Systems | 10/15/2004 | |
| PAT Answers: FDA's Final Guidance | U.S. Food and Drug Administration | 10/14/2004 |
| FDA recently released its final guidance on process analytical technology, “PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance," as part of its broader 21st Century cGMP initiative. | ||
| Best Practices for Developing a Process Control Network | Invensys | 10/14/2004 |
| This Invensys White Paper describes best practices for setting up a Foxboro I/A Series process control system network and its interfaces to a corporate network. | ||
| 21CFR Part 11 Remediation Strategies | 10/13/2004 | |
| Use Electronic Data Capture to Optimize Weighing and Dispensing Operations | 10/13/2004 | |
| Continuous Processing in Pharmaceutical Manufacturing | Matthew J. Mollan Jr., Ph.D. and Mayur Lodaya, Ph.D., Pfizer Inc. | 10/13/2004 |
| This paper provides an overview of the continuous processing landscape — from dealing with FDA to the intricacies of continuous chemical reactions. The authors, from Pfizer Inc.’s Pharmaceutical Sciences division, say the industry will change dramatically in the next decade. | ||
| The MES Performance Advantage | 07/16/2004 | |
| Applying PAT to Crystallization | Lawrence X. Yu, Robert A. Lionberger, Andre S. Rawa, Rosario D'Costa, Huiquan Wu and Ajaz S. Hussain, FDA/CDER | 07/16/2004 |
| Crystallization processes pose challenges to manufacturers who seek to apply process analytical technologies (PAT), but progress is being made. This paper, from FDA's Center for Drug Evaluation and Research, discusses the challenges and provides some examples of how they're being addressed. | ||
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