Defining 21CFR part-11 and Data Integrity (DI) requirements for new systems/application
Performing RA and DI Gap analysis on Legacy systems
Specialized in defining validation strategies for computerised / control systems by applying 'Risk Based approach' methodology
Write the policies for site computerised systems management, system security, inventory, create forms for 21 CFR Part 11 assessments , GAMP 5 category assessment , CSV protocols and reports.
