Steve Cates, Founder
Steve started Icon Systems based on a marketplace need to support MAI Manbase ERP users. As technology has evolved and customers required new software to meet their needs, Steve expanded to offer ERP selection and implementation project management. He has managed or consulted with the data conversion and implementation of QAD MfgPro, BatchMaster, Infor Syteline, and Infor Visual. He offers clients a report writing capabilities using Crystal, Access, Progress, and Cyberquery.
In 2002, Steve completed his first ERP validation at a vitamin company and since then has created and implemented over two dozen FDA software validations. With clients such as a vitamin manufacturer, a tea manufacturer, a juice manufacturer, and an aerospace company, he has handled a range of regulated manufacturing requirements using GxP principles.
Steve has dealt with the complexities of FDA regulations regarding batch sizes, weighing system requirements, change control over the formula entry and maintenance procedures, and many more specific company requirements related to governmental regulations.
In summary, his background in systems selection, implementation, validation, compliance, and technical assistance will help you achieve your goal of maximizing the return on investment from your ERP system.
Mike O'Donnel, Project Manager
Mike has been in software consulting since 1980. He graduated from the University of Detroit with a degree in Operations Management and from the University of Michigan with a Masters in Business Administration. Mike founded Ace Software in 1991 to support the needs of MAS Systems Manbase users. Mike has expertise in all Sage MAS 500 modules as well as Crystal reports, FRx reports, and SQL.
David Nettleton, Validation Specialist
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 192 mission critical laboratory, clinical, and manufacturing software implementation projects.