MEDICAL INFORMATION INSPECTION/AUDIT READINESS ASSESSMENT TOOL In the April 2017 edition of PIPELINE, we published an article, written by Salma Ibrahimo, on Medical Information Inspection Readiness. The article aimed to provide guidance for medical information teams preparing for inspections, and included a checklist to help identify key points to focus on during their preparation. The PIPA MI Workstream reviewed this checklist at the end of 2019, and have made some updates to ensure that it is still current. An electronic version of this document can be downloaded from the PIPA website via: https://www.pipaonline.org/Medical-Information-Inspection-Readiness-Checklist Document Process Do your MI processes align with global and regional documentation, and if there are any local variations are these documented? Can you describe each step? Can you clearly indicate the relationship with Pharmacovigilance and Quality Assurance to ensure adverse events (AEs) and product quality complaints (PQCs) are reported? Are you able to describe the process for handling MI requests on safety related topics? Can you retrieve all up-to-date MI applicable standard operating procedures (SOPs)/working practices and any relevant documented local business processes? (e.g. SOPs/working practices describing company requirements and processes followed by MI staff to report AEs/PQCs, to comply with copyright, data protection etc). Process Details If you have a local policy/regulatory requirement of retaining hard copy source documents, then ensure your archiving procedure is clear. If you are taking detailed paper notes prior to logging into your database, ensure the notes are scanned and attached to the system. Do you provide an out of hours service? If so, do you have a process flow chart or documentation to support this service? Is testing of the service performed and adequately documented? If you do not provide an out of hours service, do you have a process to ensure AEs and PQCs are handled/processed in the required timeframe (if reported) (e.g. left on voicemail after business hours, during a holiday shutdown, system outage)? Do you have a current disaster recovery/business continuity plan that covers your processes, as appropriate? What type of back up do you have for your department to show continuous daily business hour coverage? (i.e. to ensure AEs and PQCs are handled/processed in the required timeframe). Process Roles Job descriptions - does a job description exist for all positions in MI (contract or permanent)? (The job description should describe all key activities of the current role). Training Can you provide the role based curriculum for MI in your country/location if asked? Are training records for MI staff complete? Do you have an onboarding/training program for new MI staff? Is this documented?
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