BioBoston Consulting | Audit-Driven CSV Remediation for Life Sciences
Legacy and inherited computer systems remain a persistent compliance risk across life sciences organizations. We often see these systems continue to support critical GxP processes despite incomplete validation histories, missing documentation, or limited audit coverage, especially following acquisitions, mergers, or rapid growth.
BioBoston Consulting provides practical, risk-based CSV gap closure for legacy and inherited systems, aligning remediation activities with internal and supplier audits to restore compliance and inspection readiness.
Where Legacy and Inherited Systems Create Risk
Common issues identified during audits include:
- Systems placed into operation before the current CSV expectations were defined
- Inherited platforms with limited or missing validation documentation
- Internal audits that identify gaps but lack clear remediation pathways
- Supplier systems not adequately assessed or re-qualified
- CAPAs that address symptoms but not systemic CSV deficiencies
Left unaddressed, these gaps frequently lead to inspection observations and data integrity concerns.
Why Practical CSV Remediation Matters
Regulators expect all GxP relevant systems, regardless of age, to be validated and controlled.
Effective remediation ensures:
- Risk-based assessment of legacy and inherited systems
- Audit findings translated into actionable CSV remediation plans
- Documentation reconstructed or supplemented where needed
- CAPAs implemented and verified for long-standing system issues
- Systems prepared for FDA inspections and data integrity reviews
This approach reduces regulatory exposure without unnecessary revalidation.
BioBoston’s Approach to Legacy System CSV Gap Closure
At BioBoston Consulting, we focus on practical, defensible remediation, informed by audit findings and regulatory expectations.
- Audit-Informed System Gap Assessment
We start with a focused assessment:
- Review internal and supplier audit findings related to legacy systems
- Evaluate intended use, system criticality, and compliance risk
- Identify gaps in validation, documentation, and system controls
- Prioritize remediation based on inspection and data integrity risk
This ensures remediation efforts are targeted and proportionate.
- Risk Based Remediation and Validation
We close gaps efficiently and defensibly:
- Development of remediation plans aligned with GAMP 5 principles
- Execution of targeted IQ/OQ/PQ or retrospective validation where appropriate
- Integration of audit findings into CAPAs and corrective actions
- Creation of inspection-ready documentation supporting system control
The focus is on restoring compliance without disrupting operations.
- Sustaining Compliance Through Audits and CAPAs
Remediation must be durable:
- CAPA effectiveness checks tied to internal and supplier audits
- Ongoing monitoring and risk reassessment of remediated systems
- Integration with QMS and inspection readiness programs
- Preparation of teams to explain remediation decisions during inspections
This ensures legacy systems remain compliant over time.
A Pattern We Frequently See
Following an acquisition, a Biotech company inherited multiple laboratory systems with limited validation records. An internal audit identified significant CSV gaps. BioBoston implemented a risk-based remediation strategy, closed documentation gaps, executed targeted validation, and verified CAPAs, resulting in inspection ready systems without full re-implementation.
How BioBoston Consulting Supports Legacy CSV Remediation
We provide end-to-end, audit-informed CSV remediation services, including:
- Risk-based assessment of legacy and inherited systems
- Internal and supplier audits focused on CSV gaps
- Practical remediation planning and execution
- CAPA development, implementation, and verification
- Inspection readiness support and regulatory coaching
With 350+ senior consultants, including former FDA investigators, BioBoston helps organizations close CSV gaps in legacy systems with confidence and credibility.
Close CSV Gaps Without Disrupting Operations
If your organization relies on legacy or inherited systems with unresolved CSV gaps, BioBoston Consulting can support practical, audit-driven remediation that restores compliance and strengthens inspection readiness.
Contact BioBoston Consulting to remediate legacy systems and achieve defensible, inspection ready CSV compliance.