Contextual AI

Overview
At Validfor OÜ, Artificial Intelligence is used as a supporting capability within our digital validation environment, not as an autonomous decision-making system.
Our Contextual AI framework enhances documentation quality and lifecycle consistency by providing data-driven insights under human supervision. All AI-assisted features are designed, verified, and maintained in alignment with regulatory expectations such as GAMP 5, Annex 11, and 21 CFR Part 11.

Regulatory Disclaimer
Contextual AI does not replace qualified personnel, validation experts, or any required human review.
AI-generated recommendations are advisory only and must be reviewed and approved by authorized users before implementation.
No automated action or system change is executed without explicit human confirmation.

What Contextual AI Does

  • Supports the organization of validation data and documentation.
  • Suggests relationships between requirements, tests, and deviations based on historical records.
  • Highlights potential gaps for human review.
  • Assists in maintaining consistency across validation records.

What Contextual AI Does Not Do

  • It does not autonomously validate, approve, or reject any process or system.
  • It does not generate regulatory submissions or certification statements.
  • It does not alter or delete validation records.

Compliance and Data Protection

  • All Contextual AI operations occur within Validfor’s controlled, validated infrastructure.
  • Data used for AI analysis remains within the client’s secure environment and is processed according to GDPR and contractual data-processing agreements.
  • AI models are subject to internal validation, audit trail logging, and documented change control.

Principles of Contextual AI

  • Human-in-the-Loop: every recommendation requires human confirmation.
  • Traceability: each AI action is logged with timestamp, user, and reference data.
  • Transparency: the logic behind each recommendation can be reviewed and documented.
  • Integrity: AI functions are validated as part of the overall software lifecycle (per CSA guidance).
  • Security: models and datasets are protected by encryption and role-based access control.

Benefits (Non-Regulatory Claims)

  • Reduces manual review time and repetitive administrative work.
  • Improves traceability and consistency of documentation.
  • Helps users identify incomplete or inconsistent records before audits.
  • Facilitates continuous improvement and knowledge capture.

Statement of Responsibility
Validfor OÜ remains fully responsible for the design, maintenance, and validation of the Contextual AI features within its software platform.
Customers remain responsible for verifying that AI-assisted outputs are suitable for their intended use and for maintaining compliance within their own regulated environments.

Contact
For compliance documentation, validation summaries, or AI audit information, please contact info@validfor.com.