Computerized systems rarely remain static after go-live. Configurations evolve, users change, integrations expand, and business needs shift. Yet we often see CSV programs treat validation as a one-time milestone, leaving configuration control, change management, and ongoing system use under defined circumstances. During FDA inspections, regulators increasingly test whether validation is maintained across the system lifecycle not just at initial qualification.
At BioBoston Consulting, we design lifecycle-driven CSV programs that support configuration, change, and continuous use in line with FDA and GxP expectations. Our approach ensures validated systems remain in control as they evolve, supporting reliable data and inspection readiness over time.
Why lifecycle-driven CSV matters
Across Pharma, Biotech, and MedTech organizations, we frequently observe:
- Validated systems with undocumented configuration changes
- Change control processes that do not clearly assess validation impact
- Limited oversight of user access, roles, and privileges over time
- Validation documentation that does not reflect current system state
These gaps often surface during inspections when regulators examine how systems are maintained after implementation.
BioBoston’s lifecycle-driven CSV approach
BioBoston Consulting builds CSV programs that embed validation into day-to-day system governance, rather than treating it as a one-off activity:
- Configuration management
Defining baseline configurations, documenting critical settings, and controlling configuration changes - Change and upgrade management
Risk-based impact assessments to determine revalidation needs and testing scope - Continuous use controls
Ongoing oversight of access management, audit trail review, backup, security, and periodic review - Validation maintenance
Clear linkage between CSV, deviation management, CAPA, and internal audits - System retirement and data continuity
Ensuring data integrity, retention, and traceability through decommissioning
This lifecycle focus ensures systems remain validated as they change.
Aligned with FDA inspection expectations
Our consultants including former FDA investigators and senior GxP auditors, design lifecycle-driven CSV with inspection behavior in mind. We help organizations demonstrate:
- Control over system configuration and changes
- Clear, risk-based decisions for validation maintenance
- Ongoing data integrity aligned with ALCOA+ principles
- Evidence of continuous compliance between inspections
CSV documentation and processes are structured to clearly explain how systems stay in control over time.
Practical outcomes that support long-term compliance
Organizations engaging BioBoston Consulting gain:
- Sustainable CSV programs that support evolving systems
- Reduced risk of inspection findings related to system changes
- Improved collaboration between IT, quality, and operations
- Confidence that validation keeps pace with business needs
If your CSV program stops at go-live, regulatory risk increases as systems evolve. BioBoston Consulting can help design lifecycle-driven CSV programs that support configuration, change, and continuous use, strengthening data integrity and inspection readiness over time.