Validation documents must be signed and dated by whom to be valid?

Validation documents must be signed and dated by whom to be valid?

• A. They must be kept for 2 years
• B. They must be signed and dated by responsible establishment officials
• C. They must be filed with local authorities
• D. They must be in English

Answer: (B)

Validation documents are considered valid only when the person with authority to approve them has reviewed and signed off on them, with a dated entry. This sign-off creates a clear, auditable record showing who approved the validation and when, which is essential for accountability and traceability during audits or inspections. The responsible establishment officials are those designated by the organization to authorize validation work, such as a QA manager or a designated validation lead. Their signature and date confirm that the document reflects an actual review and authorization, not just a draft. Retention, filing with authorities, or language requirements don’t establish this authorization ability. Keeping records for a set period is about storage, filing with authorities is about submission, and language is about comprehension—none of these prove who approved the validation.

Validation documents are considered valid only when the person with authority to approve them has reviewed and signed off on them, with a dated entry. This sign-off creates a clear, auditable record showing who approved the validation and when, which is essential for accountability and traceability during audits or inspections. The responsible establishment officials are those designated by the organization to authorize validation work, such as a QA manager or a designated validation lead. Their signature and date confirm that the document reflects an actual review and authorization, not just a draft.

Retention, filing with authorities, or language requirements don’t establish this authorization ability. Keeping records for a set period is about storage, filing with authorities is about submission, and language is about comprehension—none of these prove who approved the validation.