Full Regulated Computer Systems Implementation · Full project management of a regulated application deployment. · Production of Project Management/CSV plan · Structuring & gathering user requirements · Preparation of system requirements · Preparation/execution of installation qualification, operational/performance qualification · Preparation of Validation Summary Report
Consultancy on the CSV Process · Development of CSV Procedures · Policy statement development · Template document development
CSV Process and Quality Training · Training on regulatory requirements – current thinking · Meeting the requirements · Delivering a qualified system · Maintaining the validated state · Risk analysis applied to CSV · Data Integrity and CFR 21 part 11