Genentech CCP2 Project


This project was an extensive retrofit of an automation program with an aggressive schedule. The project was to restart a Honeywell-based DCS and MES, which we qualified in 2005.


The CAI team used a risk-based approach to author and execute computer validation FAT, SAT, IQ, OQ, Design Reviews (EDR/DQ), and traceability matrices for over thirty process classes. Commissioning Agents managed a team of twelve Engineers for Automation and Process Engineering support. Our duties were to develop the automation qualification project plan, develop a design review plan for the full project, including all systems related to automation and equipment; complete automation vendor quality control plan review and input; develop and execute FAT plan; review and generate automation functional and detailed design specifications; generate standard testing templates and methods for all automation systems; support change control and software change management; and generate summary reports for all documents.

Project Success

Project plan and management support for CCP2 Return to Service automation integration and validation. Our team has identified critical path items and design issues which have resulted in early intervention to prevent schedule delays. Our use of risk assessments and detailed planning has allowed the team to absorb turnover delays from engineering and debug such that overall schedule is not impacted.



Time Frame

2003 – Present

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