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Project characteristics - UVA10abc  NOTOCORD warranties - UVA10abc
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Topic

Description

Duty

Prerequisite documents and files

Mandatory documents and files to be handed to NOTOCORD for the Upgrade Validation Assistance project.

The list is detailed in the Prerequisites section.

Must be provided prior to the beginning of each phase of the Upgrade Validation Assistance project.

Documents Review

One or several persons from the Customer’s team is/are able and authorized to review validation documents for regulatory compliance.

NOTOCORD cannot be the Reviewer.

Available in the Change Control form and in the Signature log.

Documents Approval

One or several persons from the Customer’s team is/are able and authorized to approve validation documents for regulatory compliance.

NOTOCORD cannot be the Approver.

Available in the Change Control form and in the Signature log.

Delay for review

Duration between the moment NOTOCORD sends the prepared document to the Customer reviewer, and the moment the reviewer sends back the document to NOTOCORD, either with comments or with reviewed signature.

Customer document review within 3 working days.

Delay for approval

Duration between the moment NOTOCORD (or the reviewer) sends the prepared document to the Customer approver, and the moment the approver sends back the document to NOTOCORD and the reviewer, either with comments or with approval signature.

Customer document approval within 5 working days.

Regulatory compliance

Accomplishment of:

  • GLP compliance per FDA and OECD regulations
  • 21 CFR Part 11 compliance.
  • Any other applicable regulation requested by the Customer and linked to GLP software validation.

 

The Customer is responsible for reviewing all actions, results and documentation for regulatory compliance.