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Validation

1. Internal validation​

Prior to the validation process in IUCLID6, the ChemAssist platform carries out an internal validation of data entry to make sure the overall dossier is correct. This is also referred to as a cascading validation, ensuring only the fields required are filled in on IUCLID6. Without validation, there would be inaccuracies and errors when submitting to IUCLID6.

2. Validation in IUCLID6​

When processing chemical studies and data in IUCLID6, the validation process ensures that the information entered into the database meets certain criteria and standards. Here's an overview of the validation process in IUCLID6:

Real-Time Validation​

  • IUCLID6 is equipped with a set of predefined data validation rules. These rules are designed to check the entered data against established standards and compliance requirements.
  • As users enter data, IUCLID6 performs real-time validation checks. This means that the software immediately flags any issues or discrepancies, helping users to correct errors promptly.

Validation Messages​

If IUCLID6 detects any inconsistencies or non-compliance with the predefined rules, it generates validation messages. These messages provide detailed information about the issues found, helping users understand and address the problems.

Warning and Error Messages​

  • IUCLID6 classifies validation messages into warnings and errors. Warnings indicate potential issues that may not prevent data submission but should be reviewed. Errors, on the other hand, signify critical issues that need resolution before the data can be considered valid.
  • Users are responsible for reviewing and addressing the validation messages. This may involve correcting data entries, providing missing information, or updating the records to comply with regulatory requirements.
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Data recorded in IUCLID6 can be validated by a IUCLID6 module called 'Validation assistant'. This module provides a catalogue of validation rules that can be extended and applied to a set of IUCLID documents relevant for a specific regulatory context.

Final Review​

Before finalizing and submitting data, users should carefully review the entire dataset to ensure that all validation issues have been addressed. This is a crucial step to guarantee the accuracy and reliability of the information stored in IUCLID6.

Submission to Regulatory Authorities​

Once the data has passed the validation process and has been reviewed, it can be submitted to regulatory authorities as part of compliance with various chemical regulations, such as REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) in the European Union.

In summary, the validation process in IUCLID6 involves real-time checks, detailed validation messages, and user-driven corrective actions to ensure that the chemical data entered into the system is accurate, consistent, and compliant with regulatory requirements.