Computer Systems

We follow standard operating procedures that support FDA 21 CFR Part 11, Electronic Records and Signatures, the HIPAA Security Rule, and UC and campus IT policies. IT and the DMG collaborate with DEB QA to ensure that procedures are in place to address procedures, training, security, change control, vendor management, and qualification and testing of our network infrastructure and DMG systems.

QA Areas of Responsibility

• Design and develop QA program
• Administer training program
• Plan, review, and administer SOPs
• Oversee computer system validation/software quality assurance
• Conduct internal audits of procedures, studies, and computer systems
• Conduct external vendor audits
• Host sponsor and FDA audits
• Implement and monitor HIPAA security regulations and UCSF policies
• Develop and deliver quality system training

Contact Susan Butler, QA Director, if you have questions about the QA program.