Trialeco has published a dedicated page describing how a system should be checked before a pilot. It sets out eight control areas: purpose and status; roles and human decisions; quality verification; data provenance and minimisation; access and action history; change and resilience; deviation handling; and regulatory and scientific foundations. The confirmed stage is a publicly described project framework and a demonstration using synthetic data. The site distinguishes “designed”, “shown in a demo”, “verified in a pilot” and “implemented”; compliance with each requirement must be confirmed for each configuration. The practical value is to define permitted data, role rights, a reference standard, critical errors, acceptance criteria, stop conditions and change procedures in advance. A reference to a regulatory document does not establish compliance automatically. The demo does not replace technical, clinical, operational or regulatory verification. The system may assemble deviation materials, but classification, CAPA, closure and effectiveness checks are approved by designated quality functions. Clinical, ethical and regulatory responsibility is not transferred to AI.
Project review
Trialeco: eight checks before a pilot
Trialeco has published a dedicated page describing how a system should be checked before a pilot. It sets out eight control areas: purpose and status; roles and human decisions; quality verification; data provenance and minimisation; access and action history; change and resilience; deviation handling; and regulatory and scientific foundations. The confirmed stage is a publicly described project framework and a demonstration using synthetic data. The site distinguishes “designed”, “shown in a demo”, “verified in a pilot” and “implemented”; compliance with each requirement must be confirmed for each configuration. The practical value is to define permitted data, role rights, a reference standard, critical errors, acceptance criteria, stop conditions and change procedures in advance. A reference to a regulatory document does not establish compliance automatically. The demo does not replace technical, clinical, operational or regulatory verification. The system may assemble deviation materials, but classification, CAPA, closure and effectiveness checks are approved by designated quality functions. Clinical, ethical and regulatory responsibility is not transferred to AI.