GDP Inspection Pack Builder™

Build a structured GDP inspection pack that brings requirements, evidence, decisions, actions and inspection themes into one explainable preparation record.

35–60 minutesSaved locally in this browser

What should I prepare?

Good inspection-pack inputs look like this. Focus on what an inspector or senior reviewer would need to understand quickly: evidence location, process owner, current status, known gaps, narrative position and the action needed before the pack is relied on.

Data and QMS boundary

Local-only tool. Entries stay in this browser. No AI processing. No database save. Use the output as draft inspection-preparation material and transfer reviewed content into your QMS, evidence pack or governance process.

Method and output

Example data expectation. Example data should avoid generic document lists. It should show realistic evidence owners, open gaps, retrieval routes, narrative weaknesses and follow-up actions for inspection preparation meetings.

How to use the builder

Work through the pack in stages so the final output tells a clear, evidence-led inspection story.

Context: 5–8 min to define site, licence, RP and review period.
Evidence map: 10–15 min to capture evidence status, owners and open actions.
Control narrative: 15–25 min to describe GDP controls and governance.
Report / export: 5–12 min to review, copy and print the pack.

How to interpret the output

The pack should support inspection preparation by making current readiness, evidence ownership, open gaps and the compliance narrative visible.

Open risks should remain visible until closed.
Evidence gaps should have owners and due dates.
The final narrative should be factual and evidence-led.

Common evidence architecture. Use the same evidence chain across execution and inspection preparation: Requirement / oversight area → Evidence → Owner & location → Status / gap → Judgement / decision → Action / owner → Inspection theme / pack linkage. Cross-tool transfer is currently manual; controlled records remain in your QMS.

GDP Inspection Pack Workspace

Step 1 of 5 — Context

0% completeDefine context · 5–8 min

Local draft not saved yet

Local draft only. Nothing is submitted, stored or reviewed by RegOpsPro.