JAMES G. ROBERTSON, P.E email
Consulted to attorneys on 21 legal matters, provided expert testimony at trial and in deposition. Cases involved Supervisory Control and Data Acquisition (SCADA) and other industrial control system matters including related software patents. Technologies were for Programmable Logic Controllers (PLC) and computers in numerous applications including water treatment, co-generation, utilities, pipelines, and controls for large electrical motors.
Recently completed forensic investigation and analysis of SCADA and control system role in the San Bruno, California natural gas pipeline rupture and fire.
Mr. Robertson operated a small R&D lab for 7 years in which he developed several embedded microprocessor electronic systems from board level. These included a custom user programmable automated control for large press brakes, a personal H2S monitor with alarm, and a nuclear fuel rod profilometer for GE. Extending beyond the years that he operated the lab, he developed over 60 small Supervisory Control and Data Acquisition (SCADA) systems for water treatment plants. These incorporated Programmable Logic Controllers (PLC) from several manufacturers along with PC based SCADA software applications from Wonderware, Intellution and Allen Bradley..
He left the lab to develop software, firmware and BIOS for two custom instruments for CooperVison. These were ultrasound scanners, one with a one- dimensional display and the other with two-dimentional display and several overlays. They were quantitatively accurate devices which calculated the lens power for implant during cataract eye surgery. These instruments were challenging engineering tasks both in hardware and software given the Intel 286 microprocessor technology of the time.
HIs work with the Ultrasound Scanners led to Mr. Robertson being tapped for a VP of Engineering slot in a venture capital funded start up to manufacture and market electronic engraving machines. In two years the company was sold and Mr. Robertson began consulting on large international telecom, GIS and SCADA projects.
LARGE SYSTEMS & INTERNATIONAL CONSULTING
Mr. Robertson was a member of the EU project management team for a 1000 km, high pressure natural gas pipeline in Greece. He was responsible for tendering specifications of the SCADA, and service telecommunications along the pipeline route. The system has over 40 radio towers, 40 pumping stations, a dedicated fiber optic communication line for the SCADA with backup provided by the telephone system.He reviewed, for the World Bank, the design of the Natural Gas Transmission SCADA in Poland that was originally designed by BP. He performed two missions for the U.S. Trade Development Agency. These were feasibility studies for potential projects to be funded by the World Bank. One was an Electronic Data Interchange (EDI) project in Chile and the other was for two Geographic Information Systems (GIS) projects in Turkey.
He wrote the procurement specification for a backup electric transmission grid SCADA in the Eastern part of Saudi Arabia.
Volunteer as Unaffiliated Outside Member of the FDA/CBER Institutional Animal Care and Use Committee (IACUC) at National Institutes of Health (NIH) in Bethesda, Maryland.
Mr. Robertson consults on compliance of software, computers, information systems and IT infrastructures in the Pharmaceutical, Biotech and Medical Device industries. This both for compliance with FDA regulations and with Sarbanes Oxley Act part 404. He teaches a method to extend IT controls to satisfy the Quality Unit's requirements. He is an expert with 21 CFR Part 11 compliance. He was written articles, contributed a chapter for a Wiley compliance book, presented webinars and at conference.
Mr. Robertson developed a complete system of over 60 policies and procedures at a start up Biotech company to satisfy their IT governance requirement and their computer/software validation requirement. for He has coached client Validation and Quality personnel on Risk methods for validating software and IT infrastructure. He has worked with many systems, including chromatography skids, laboratory instruments, purified water, water for injection, environmental monitoring, ERP, HVAC for clean areas, differential pressure management and many software driven machines. Mr. Robertson holds Certification as Information System Auditor (CISA - non-practicing).
After earning BSEE and MSEE degrees at the University of Washington, Mr. Robertson programmed the inertial navigator computers used on submarines at Autonetics (now Boeing). Following that, he worked four years with ESL, a consulting company serving US government agencies, and then entered the civilian realm. There he managed a department that engineered the control systems for water treatment plants. This led to his own consulting operation in Mountain View, California where he continued the industrial control work including development of computerized controls for a press brake, and firmware for ultrasonic scanning instruments used in ophthalmic surgery. Over a course of 11 years he developed over 60 SCADA and control systems.
His reputation with the ultrasonic instrumentation led to being tapped by a venture capital firm to join a start up, Pantograph, in Larkspur, California. to produce and market computerized engraving machines. After two years as VP Engineering there, the company was sold and he began consulting on the EC, World Bank and US Trade Development Agency SCADA & GIS projects. Subsequent to this he returned to the engineering of industrial controls this time in the pharmaceutical industry. He also began consulting to the legal community on software patents, process controls and Supervisory Control & Data Acquisition (SCADA) systems.
Subsequently he obtained certification from the Information System Audit and Control Association (ISACA) for Information System Audit (CISA). Currently he consults primarily to the pharmaceutical industry on compliance of their information systems with regulations of the U.S. Food and Drug Administration (FDA). He also provides expert services to attorneys.
James G. Robertson
North Bethesda, Maryland