GxP Compliance Advisory
Computer Systems Validation (CSV) Consulting
We provide Computer Systems Validation (CSV) consulting services for software systems and technology solutions in regulated environments.
Our consulting covers validation strategy, 21 CFR Part 11 compliance, data integrity (ALCOA+), and audit readiness preparation. We help organizations navigate complex validation requirements and ensure their systems meet regulatory standards.
Our CSV consulting services include validation planning, risk assessment, specification development, test protocol design, and validation summary report preparation. All consulting deliverables reference software systems, technology solutions, and regulated or enterprise environments.
Whether organizations are validating new systems, remediating existing systems, or preparing for audits, our compliance advisory services provide the expertise needed to achieve and maintain validated state.
Key Compliance Areas
21 CFR Part 11
Ensure electronic records and signatures meet FDA requirements for authenticity, integrity, and auditability in regulated systems.
Data Integrity (ALCOA+)
Implement data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete (plus Complete, Consistent, Enduring, Available).
Audit Readiness
Prepare validation documentation, evidence packages, and audit trails that demonstrate compliance and system validation.
Validation Services
Our validation consulting services cover the complete validation lifecycle, from initial planning through ongoing maintenance. We provide expert guidance on validation strategy, risk assessment, and documentation requirements.
We help organizations develop validation plans, create specifications, design test protocols, and prepare validation summary reports. Our consulting ensures that validation activities align with regulatory requirements and industry best practices.
Consulting Deliverables: Validation Plan, Risk Assessment (FMEA), User Requirements Specification, Functional Specification, Configuration Specification, IQ/OQ/PQ protocols, Traceability Matrix, and Validation Summary Report.
Compliance Resources
Explore our comprehensive compliance resources and learn more about our approach to GxP compliance.
Our compliance resources provide detailed information on regulatory requirements, validation methodologies, and best practices for maintaining validated systems in regulated environments.