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Downloads, White Papers
What's In Your Batch Record? (Probably a Lot of Things That Don't Belong There)
by Mark Kovacs and Ed Sullivan, EnteGreat
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Paper Overview
The typical manually-created paper-based batch records used by Life Science companies today have been modified several times since they were originally defined and introduced. The cumulative effect of these separate incremental modifications, each of which had its own independent purpose, is often a sizable accumulation of unnecessary content in the batch record and substantial waste in the overall batch record review and management process. This waste can be eliminated from batch records and significant business value unlocked by applying Lean principals. In fact, some Life Science manufacturing companies that have applied Lean principles to their batch records, as well as the batch record review and management process, have been able to reduce the size and complexity of Batch Records by 20 to 50 percent.
Paper Outline
- Introduction
- Pitfalls for Batch Records
- The Effect of Time
- The Paper Factories
- The Cut-and-Paste Syndrome
- The Cost of Paper
- Market Drivers in the Industry
- Lean Batch Records
- What the Batch Record Is Not
- Tools for Batch Record (as well as Process) Improvement:
- Governance for Batch Records
- Looking to the Future
- Automation and Systems
- Future Roadmap
- Conclusion
About the Authors
Mark Kovacs has over 22 years of total experience with more than 10 years in the Life Science sector. As Director of Information Technology with a pharmaceutical company, Mark established both enterprise and manufacturing systems standards. In addition to his pharmaceutical experience, Mark's Life Sciences experience also include Biotechnologies and Medical Device manufacturing, ranging from simple point solutions to complex multinational deployments involving various governmental regulatory agencies.
Ed Sullivan has over 19 years experience designing, developing, and implementing manufacturing and supply chain system solutions in both North America and Europe. This experience includes roles ranging from consulting to system design and implementation across a variety of industries including Life Sciences, Food, Beverage, Chemical, and Metals. He has a BS IE and MBA from the University of Pittsburgh and an MS IE from Arizona State University. He is a registered professional engineer with membership in both ISPE as well as APICS, with both CPIM and CIRM certifications.
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