Inspection Hosting for QPPVs

To allow the organisation to avoid answering low-priority requests To provide traceability from each request through preparation, review, submission and receipt confirmation To ensure that only the QPPV can access submitted documents To replace the organisation's document management system

The scribe replaces the SME in answering technical questions The scribe records questions, responses, commitments and emerging document requests so that follow-up is controlled The scribe determines which inspector observations are legally valid The scribe approves all documents before they enter the DMS

A statement from the CAPA owner that the action was finished The revised SOP alone Documented implementation evidence plus measurable monitoring results assessed over an appropriate period The original inspection observation without further analysis

Close the finding informally once the relevant employee has been reminded of the procedure Open and manage CAPA as appropriate, preserve evidence, assess effectiveness, and update controlled artefacts through change control Remove the affected procedure from the PSMF until the issue is resolved Wait for the next inspection before documenting remediation

Describe the system generally without referring to records Refer to risk-based reviews, governance metrics, audit findings and documented decisions, with specific evidence locations Focus exclusively on the number of adverse events processed State that system suitability is assumed because no inspection has yet identified a critical finding

It provides scripted answers that prevent inspectors from asking follow-up questions It maps likely questions to expected points, evidence and responsible SMEs to improve consistency and readiness It limits interviews to questions already approved by Legal It serves as a substitute for training and mock inspections

Keeping a note of the submission in an employee's personal notebook Recording the document version, preparer, reviewer, submission time, recipient, file identity and receipt confirmation in the tracker Relying on the inspector to retain the submitted file name Uploading a document without recording which version was provided

Personally perform or verify every operational pharmacovigilance activity Demonstrate effective system-level oversight while relying on appropriately governed operational owners Transfer responsibility for inspection responses entirely to the Inspection Lead Respond only to questions concerning individual adverse event cases

It is the newest file available, regardless of approval status It is an authoritative, version-controlled document whose identity, approval and submission history can be demonstrated It is a local copy that can be edited quickly if needed It contains as much information as possible, even if unrelated to the request

Wait for the opening meeting before assigning responsibilities Confirm scope and dates, establish inspection roles, open the request tracker, and arrange logistics and interviews Rewrite all SOPs to reflect the anticipated inspection Provide inspectors with every document in the organisation's DMS