IT compliance today requires a paradigm shift from a project-specific engagement to a comprehensive, centralized compliance program.
In the past, Computer System Validation (CSV) in the life sciences was focused on software validation and infrastructure and computing platform qualification for systems that supported FDA-regulated activities and records. Today, organizations are increasingly focusing on overall, global IT compliance, to satisfy 21 CFR Part 11 but also equivalent laws in other countries, Sarbanes-Oxley (SOx), HIPAA, export and shipping regulations, and much more.
To meet these varied and global needs, pharmaceutical manufacturers must:
- Manage consistent computer system validation and system testing efforts across multiple projects and multiple sites
- Enable effective system inventory control, change management, periodic evaluations, and validation to ensure sustained compliance
- Manage ”just-in-time” deployment of qualified resources to the right places
- Provide global ”round-the-clock” access to a validation and testing center of excellence
- Provide onsite and offshore validation and testing teams that bring necessary skills at attractive cost.