|
Recent
Pharmaceutical Computer and
Automation
Quality Assurance Work
- Created
remediation strategies for
legacy computer systems
regulated by USA, Canadian,
European, Australian, and
Japanese authorities.
- Developed risk
based validation strategies for
new systems.
- Provided guidance
for implementation of electronic
records and electronic
signatures.
- Wrote policies,
guidelines, and procedures to
implement new and legacy
computer system validation.
- Developed risk
assessment strategies and tools
that help customize validation
approaches for computer systems
and spreadsheets.
- Audited computer
system developmental and
operational policies, procedures
and practices.
|