FULL LIFE CYCLE CSV SERVICES
COMPUTERIZED SYSYEM
VALIDATION (CSV)
From Master Validation Plans to Data Integrity Audits, we provide end-to-end services that ensure your computerized systems are compliant, defensible, and efficient.
Our CSV Services
Risk-Based Validation
Implementing GAMP 5 principles to focus testing efforts where they matter most, reducing overhead without compromising quality.
Key Deliverables
- Impact Assessment
- Risk Management Plan
- Traceability Matrix
21 CFR Part 11 & Annex 11
Comprehensive audits and remediation plans for electronic records and signatures to meet FDA and EMA standards.
Key Deliverables
- Compliance Gap Analysis
- Audit Trail Reviews
- E-Signature Controls
Data Integrity Audits
Deep-dive assessments focusing on the ALCOA+ principles to ensure data is attributable, legible, and accurate.
Key Deliverables
- DI Strategy Paper
- Data Mapping
- ALCOA Compliance Report
Cloud & SaaS Validation
Tailored frameworks for validating multi-tenant cloud environments and handling continuous vendor update cycles.
Key Deliverables
- Vendor Audit Report
- SaaS SLA Verification
- Change Control Framework
Legacy Sys. Remediation
Bringing older ‘grandfathered’ systems up to modern regulatory standards through retrospective validation.
Key Deliverables
- Restrospective MVP
- System Retirement Plans
- Gap Remediation
Lab & EQ Validation
Validation of Laboratory Information Management Systems (LIMS), Chromatography (CDS), and analytical equipment.
Key Deliverables
- Instrument Calibration Specs
- LIMS Config Specs
- Method Validation Support
Spreadsheet Validation
Securing complex Excel calculations and macros to ensure they are robust, validated, and error-free for compliant GxP use.
Key Deliverables
- Logic Verification
- Locking Protocols
- User Manuals
CSV Training & Culture
Customized workshops for QA and IT teams to build a sustainable, organization-wide culture of compliance.
Key Deliverables
- Online Interactive Classes
- Training Certificates
- SOP Development
SERVICE HIGHLIGHT
Mock Inspections &
Audit Support
Don’t wait for the regulator to find a gap. Our “Front-Room/ Back-Room” audit support services prepare your team for the pressure of a live FDA or EMA inspection.
100%
Audit Success
Rate
90+
Validated
What's included in Audit Support:
- Personnel Coaching & Roleplay
- Document Room Management
- Rapid Response Validation Evidence
- Post-Audit Remediation Planning
- Observation (Form 483) Defense
FAQs
Addressing the complex concerns of quality and IT leadership.
What CSV services do you provide?
We provide end-to-end Computerized System Validation services including validation planning, risk-based assessments, IQ/OQ/PQ testing, retrospective validation for legacy systems, spreadsheet validation, and audit-ready documentation aligned with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
Do you support retrospective validation for legacy (“grandfathered”) systems?
Yes. We specialize in retrospective validation of existing systems by leveraging system history, risk assessments, and current controls to bring legacy platforms into compliance without operational disruption.
How do you apply risk-based validation in CSV projects?
Our CSV services follow GAMP 5 and ICH Q9 principles, focusing validation effort on functions that impact product quality, patient safety, and data integrity. This minimizes documentation overhead while maintaining regulatory confidence.
How long does a typical CSV engagement take?
Project timelines depend on system complexity and scope. Spreadsheet or small system validations may take weeks, while enterprise or multi-system validations are executed in phased, controlled timelines.
Why should we choose your CSV services?
Our CSV services combine regulatory expertise, practical validation execution, and audit-focused documentation to deliver compliant, sustainable, and inspection-ready systems.