Validate your systems with confidence and protect data integrity
BioBoston provides end-to-end Computer System Validation (CSV) support so your electronic systems perform as intended, maintain data integrity, and meet FDA/EMA expectations especially for 21 CFR Part 11 and GAMP 5-aligned validation.
21 CFR Part 11 and GAMP 5 expertise
Risk-based validation for the right level of effort
Clear documentation for audits and inspections
Flexible support for new systems or remediation
Who this is for
This service is a fit if
- You’re implementing a new system (EDC, LIMS, QMS, ERP, MES, LMS, etc.)
- You need to remediate gaps before an audit, inspection, or customer assessment
- Your validation documentation is incomplete or inconsistent
- You need stronger Part 11 controls, audit trails, and access management evidence
- You want a practical validation approach that matches risk and business criticality
What you’ll get
- You will receive audit-ready CSV deliverables such as:
- Validation plan and strategy aligned to system risk and intended use
- Risk assessment and traceability approach to justify validation depth
- IQ/OQ/PQ (or lifecycle validation equivalents) executed with documented evidence
- Part 11 and data integrity assessment support (security, audit trails, electronic records)
- Change control and revalidation approach to keep systems compliant over time
- Complete validation package: protocols, scripts, traceability matrix, and summary report
What we do
Our CSV support can include:
CSV planning and protocol development
Risk-based validation approach (system criticality and impact)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Data integrity and security validation (including 21 CFR Part 11 controls)
Change control and revalidation support
CSV documentation and reporting (protocols, scripts, traceability, summary reports)
Why BioBoston
- CSV succeeds when it’s clear, defensible, and proportional to risk.
- We help you avoid over-validating low-risk features while ensuring high-risk functions are fully supported with evidence. The result is a validation package that stands up during audits and inspections and a system you can rely on operationally.
Validation plan + risk strategy
We define the right lifecycle approach, deliverables, and testing scope based on risk.
Execute + document
We run testing, collect evidence, and deliver a complete validation package ready for review and inspection.
Discovery call
We confirm your system, intended use, validation status, timelines, and audit/inspection drivers.
How it works
Frequently Asked Questions
We use a risk-based approach tied to intended use, data impact, patient impact, and regulatory expectations.
Yes. We can assess gaps, define a remediation plan, and build the missing documentation and evidence.
Yes. We assess and document key controls like access management, audit trails, electronic records/signatures (as applicable), and data integrity safeguards.