Evidence Readiness · GAMP 5 / AI

Regulations/GAMP 5 / AI/Evidence Readiness

Evidence objects

Readiness becomes visible through records.

GAMP 5 / AI

Evidence 01

GxP impact assessment

Keep this as a named evidence object for GAMP 5 / AI: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 02

User requirement set

Keep this as a named evidence object for GAMP 5 / AI: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 03

Supplier assessment

Keep this as a named evidence object for GAMP 5 / AI: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 04

Risk and criticality assessment

Keep this as a named evidence object for GAMP 5 / AI: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 05

Validation/assurance plan

Keep this as a named evidence object for GAMP 5 / AI: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 06

Configuration specification

Keep this as a named evidence object for GAMP 5 / AI: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 07

Test evidence summary

Keep this as a named evidence object for GAMP 5 / AI: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 08

Data integrity assessment

Keep this as a named evidence object for GAMP 5 / AI: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 09

Change control log

Keep this as a named evidence object for GAMP 5 / AI: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 10

Periodic review record

Keep this as a named evidence object for GAMP 5 / AI: source basis, owner, status, review question, and update trigger should be visible before reuse.

Readiness questions

Each object needs review before reuse.

question bank

Question 01

GxP impact assessment

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 02

User requirement set

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 03

Supplier assessment

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 04

Risk and criticality assessment

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 05

Validation/assurance plan

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 06

Configuration specification

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 07

Test evidence summary

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 08

Data integrity assessment

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Source anchors

Current public sources for GAMP 5 / AI.

official first

These links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.

Official source page / paid guidance