Quality, validation, Veeva, clinical compliance, and responsible AI

AI and GxP Readiness Assessment

Before adopting AI in a regulated environment, organizations need to understand the intended use, associated risks, required controls, and expected business value.

CliniGene evaluates your current and proposed AI use across Quality, Clinical, Regulatory, Manufacturing, and supporting technology processes.

Services Include

• AI-use and shadow-AI inventory
• Workflow and data assessment
• GxP-impact determination
• AI risk classification
• Data privacy and security review
• Vendor documentation review
• Governance gap assessment
• Use-case prioritization
• Validation recommendations
• 90-day implementation roadmap

AI Governance and Assurance

CliniGene helps establish the controls required to use AI responsibly in regulated life-sciences operations.

AI-generated content remains a draft until it has been reviewed and approved by an authorized individual.

Services Include

• AI governance framework
• AI acceptable-use policy
• Roles and responsibilities
• Risk-classification model
• Intended-use documentation
• AI vendor qualification
• Human-review requirements
• AI output-verification strategy
• Model-change controls
• Incident and escalation procedures
• Training and adoption support
• Periodic performance reviews

Computer System Validation and Computer Software Assurance

CliniGene provides risk-based validation services for GxP applications and technology changes.

Our documentation is aligned with the system’s intended use, applicable procedures, identified risks, and the customer’s quality framework.

Deliverables May Include

• System impact assessment
• GxP assessment
• Electronic records and signatures assessment
• Validation plan
• User requirements specification
• Functional or configuration specification
• Risk assessment
• Supplier assessment
• Verification or UAT protocol
• Requirements traceability matrix
• Deviation documentation
• Validation summary report
• Production-verification checklist
• Periodic review

Veeva Quality Systems Services

CliniGene supports organizations implementing, maintaining, or improving Veeva Vault applications.

CliniGene is an independent consulting company. References to third-party products do not imply a formal partnership unless expressly stated.

Areas of Support

• Veeva QualityDocs
• Veeva QMS
• Document lifecycles and workflows
• Quality-event processes
• Roles, permissions, and security
• Configuration-change assessment
• Business verification and UAT
• Release-impact assessment
• Regression-test planning
• Periodic reviews
• Audit-trail review support
• SOP and configuration alignment
• Post-production verification
• Managed Quality Systems support

Quality Management Systems

We help emerging life-sciences companies establish and improve practical, scalable quality systems.

Services Include

• Quality manual development
• SOP, policy, form, and template creation
• Document-control processes
• Change-control management
• Deviation and investigation support
• CAPA development and effectiveness checks
• Training program development
• Vendor qualification and oversight
• Audit preparation
• Inspection-readiness assessments
• Quality metrics and management review
• Data-integrity assessments
• Remediation planning

Clinical Quality and Compliance

CliniGene helps sponsors and CROs strengthen clinical quality, documentation, and oversight.

CliniGene does not replace medical judgment, investigator responsibilities, sponsor oversight, or required regulatory approvals.

Services Include

• Clinical Quality Management System support
• ICH GCP gap assessments
• ICH E6(R3) readiness
• eTMF completeness and quality reviews
• Essential-document reconciliation
• Sponsor and CRO oversight
• Vendor qualification
• Protocol-deviation trending
• CAPA support
• Clinical-system validation
• Mock inspection support
• Inspection-readiness planning

Fractional Quality and Validation Support

Companies that do not need a full-time Quality Systems or CSV leader can engage CliniGene for flexible continuing support.

Engagements can be structured as individual projects or monthly managed-service arrangements.

Fractional Support Can Include

• Quality Systems leadership
• Validation program management
• Veeva change support
• Change-control review
• Validation-document review
• Periodic reviews
• Audit and inspection preparation
• Supplier oversight
• Quality metrics
• Project and vendor coordination