PMP Practice: Monitor and adjust risk management activities

Layla Hashemi-Rad is managing a pharmaceutical compliance project for Silverback BioSolutions, implementing a new laboratory information management system across 12 regulated facilities. The project has a fixed regulatory deadline in 18 months, requires validation against FDA 21 CFR Part 11 standards, and involves extensive documentation for audit trails. During kickoff, the laboratory operations director suggests using an iterative approach with two-week cycles to get faster feedback from lab technicians and adapt the system configuration based on their input. The IT security lead counters that the compliance documentation requirements and validation protocols need comprehensive upfront planning. Layla has already baselined the scope and received sign-off on detailed technical specifications from the quality assurance team. The project budget is fixed and the sponsor has emphasized that any scope changes require formal change control due to validation impacts. How should Layla approach risk management for this project?