PSMF Inspection Readiness Knowledge Assessment

The vendor's geographic distance from the MAH The length of the vendor's company name The criticality and risk of the outsourced PV activity Whether the vendor has previously worked for another pharmaceutical company

It ensures that product descriptions use the same commercial branding everywhere. It detects differences between PV responsibilities and authoritative commercial or regulatory sources so discrepancies can be investigated. It eliminates the need for change control when products are transferred. It allows inactive products to remain listed indefinitely without explanation.

Only the date on which the revised PSMF was uploaded The change scope, affected sections, risks, required actions, approvals and completion evidence That every change must be implemented immediately without risk assessment That updates can be approved verbally if the change appears minor

Preparing a new inspection folder after receiving an inspection announcement Conducting a surprise internal review or mock inspection and measuring retrieval time and response quality Increasing the number of pages in the PSMF Asking the document owner whether the PSMF feels complete

Using the same font and document layout in both systems Performing periodic reconciliation so names, contact details and deputy arrangements remain consistent Allowing each system owner to update information independently without notification Removing deputy information from the PSMF to avoid inconsistencies

To ensure retired systems continue to be treated as production systems To preserve evidence of decommissioning, data migration and archive verification To avoid updating the current PSMF after system replacement To allow users to continue entering cases into obsolete systems

Inspection readiness is primarily achieved by expanding the PSMF until it contains every operational document. Inspection readiness is a governance condition demonstrated by an accurate PSMF and effective supporting controls. Inspection readiness depends mainly on completing a formal PSMF review immediately before an inspection. Inspection readiness is established when all PSMF annexes have identical formatting and page numbering.

The meeting has a recurring calendar invitation. The meeting minutes contain a long list of discussion topics. Decisions and actions have assigned owners, due dates, status and closure evidence. The meeting is attended only by senior executives.

Evidence should be concise, indexed and directly mapped to the question being addressed. All inspection evidence must be provided only in printed form. Evidence is unnecessary when the QPPV gives a verbal explanation. The PSMF should contain every underlying record in full.

The system's marketing brochure and user interface screenshots only The system owner, version, validation status, change history, data flows and relevant migration or integrity evidence The number of employees who have viewed the system homepage The age of the vendor's corporate logo