About us

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

Quality Review
·        CSV audit
·        Supplier audit
·        Validation document review/approval

CSV Readiness Evaluation
·        GAP analysis on procedures
·        GAP analysis on specific systems
·        Planning for a new development

Planning for a major upgrade - think about validation and regulated implementation!