Inspection Readiness Plan
Pre-approval and routine inspection readiness plan template: submission-to-evidence traceability, site readiness assessment, mock-inspection programme, ALCOA+ data-integrity assurance of inspectable records, front-room/back-room logistics, and CAPA for readiness gaps.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
A plan for demonstrating the facility and its records to a regulator: tracing every submission commitment to on-site evidence, stress-testing the site with mock inspections, assuring the integrity of inspectable records, and organising the logistics of hosting the inspection. The commitment that resolves to no retrievable record is the gap this plan exists to find, and finding it late is the expensive outcome.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
An inspection tests whether the quality system described in the submission exists in practice. 21 CFR Part 211 and ICH Q10 define what the inspector expects to find operating, ICH Q9(R1) supports risk-ranking which records and areas to ready first, and ALCOA+ expectations apply to every record that may be requested. None of them tells you which commitments are hardest to evidence at your site — that assessment is yours, and the matrix is where it becomes visible. The readiness structure is SPEQ practitioner synthesis.