CV:

Karl has spent the last 20 years implementing manufacturing computers systems for the life science industry.  He is an expert in Manufacturing software solutions and has led cross functional teams responsible for their deployment.  Currently he is a Vice President at EIS, Inc. where he heads business development and oversees the west coast operations.

He obtained his undergraduate degree in Information Systems at The Ohio State and a MBA from Oxford in the United Kingdom.

OVERVIEW Enhanced Information Solutions (EIS) is a system integrator focused on computer systems that optimize life science manufacturing. From manufacturing mobile apps installed on such devices as the iPad, to the implementation of full-featured Manufacturing Execution Systems (MES), EIS provides software solutions that meet manufacturing needs. Our consultants have expertise in all stages of the software project life cycle, including vendor selection, requirements gathering/analysis, design, implementation, validation and ongoing support. With 20+ years in the life science industry, EIS has a strong track record of repeat customers while working with the majority of large pharmaceutical and biotech companies. MES CONSULTING No matter what MES software you’ve chosen, the experts at EIS have the experience needed for a successful project implementation. EIS has helped dozens of clients in the biotech, pharmaceutical and medical device industries implement and validate their MES and Manufacturing Intelligence systems to improve plant operations. The staff at EIS has decades of experience on numerous projects covering the full project spectrum, from scoping and design through validation and go-live support. A strength of EIS is that we are MES vendor independent allowing us to recommend the best MES software solution for your company. EIS has worked with most of the large MES software solutions including Werum, POMS / POMSnet, Emerson Syncade and Rockwell Pharma Suite. MOBILE MES APPS In addition to MES consulting services, EIS has developed the OpsTrakker mobile application that provides MES and Manufacturing Intelligence functionality in a cost-effective manner for mobile devices (iPad, Android, Windows Mobile, Blackberry or iPhone). OpsTrakker focuses on specific use cases to provide high-value manufacturing functionality in a cost-effective manner. For example, the eForms and eLogbook modules convert spreadsheets and paper-based documents to mobile electronic forms and logbooks that reduce operator error, facilitate regulatory compliance, capture electronic records and enable data tracking for trend analysis and process improvement. Current modules and modules under development are listed below: eLogbook – Track equipment use eForms – Work instructions / Recipe Execution eInventory – Perform inventory location updates eSample – Record QC samples eBOM – Verify and record material consumptions eLineClear – Provide instructions for clearing production lines SOFTWARE VALIDATION In a government-regulated environment such as the life science industry, software validation is paramount to compliance. While documentation – and sometimes lots of it – is a standard by-product of a validation effort, the sheer volume of paperwork does not guarantee a fully-validated system. EIS has years of experience on numerous projects in varying roles. This has provided our staff with the ability to navigate any software development & implementation project through the sometimes difficult validation terrain. EIS is fully versed in the use of software industry best practices, such as GAMP5 (Good Automated Manufacturing Practices), and through solid understanding of requirements and real world use cases – EIS validation resources will test software the right way, the first time.