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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
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Document Yes/No 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?
Are the onboarding/training materials (slide decks etc.) for MI staff easily retrievable? For training completed outside of the training system, e.g. external courses, training at conferences, etc. have you added these to your training system and do they show in your electronic training transcript? If not, do you have documentation (e.g. training roster[s]) as a record of the training? For other types of training that you provide (e.g. sales representatives, external business partners [e.g. call centre agents] etc.), do you have retrievable training materials and training rosters? Personnel Is an up-to-date CV available for all MI staff (permanent and contract, including all call centre staff [if any])? Are CV(s) easily retrievable if requested? (Note: CVs for contract staff may be held by the supplier/vendor but should be readily available on request). Are CV(s) updated, signed and dated on an annual basis? Does the CV align with the job description i.e. do the skills and qualifications of the personnel in the role (this includes past employees) match with those required to perform the job? Do you have an up-to-date organisational chart? Contracts Do you have service contracts for outsourced MI service providers (if any)? Are these contracts easily retrievable? Do these contracts depict clear procedures for the handling of AEs/PQCs reports by these partners? Monitoring Can you describe the quality monitoring program for your database/system? Do you know who to contact globally if questions outside of your scope are asked? Do you have a process for monitoring the quality of MI responses provided by outsourced MI service providers? If so, is this process documented? Can you show evidence (documentation) that this is conducted on a regular basis? Do you have a documented approval/withdrawal process for non-promotional materials that the medical information team are responsible for creating/updating/disseminating e.g. scientific decks for MSLs? Do you perform spot checks on random job bags/materials to check for compliance with the process? If you are involved in the provision of risk minimisation materials, do you have a monitoring process in place to ensure that these are sent in line with the specific product’s risk minimisation plan? Regulations Can you show how you document off-label MI requests (if required) and/or off-label patient exposure? Can you describe how you determine if patient exposure is off-label? Can you show how you comply with data privacy and copyright regulations applicable to your country/ location? Inspection For your department/location, have you assigned the appropriate inspection designee(s)? (Departments/ locations may have one or more personnel designated as the point-of-contact for inspections). Have all MI staff received inspection readiness training? And is this documented? Are you aware of any previous audit/inspection findings impacting MI? Are they resolved? If they are not resolved, can you explain the status of those findings?
