# Meeting Minutes

## Metadata

| | |
|---|---|
| Organisation | Not stated |
| Reference | Not stated |
| Meeting | Client Abbott T796 - Audit kick off Sylmar |
| Date | Not stated |
| Duration | Not stated |
| Attendees |  |

## Objectives

Plan the Abbott T796 Sylmar surveillance audit and clarify Niamh’s specialist software audit role, preparation needs and logistics.

## Executive Summary

The group planned the Sylmar surveillance audit, including timing, hotel and site logistics, training, document access and Niamh’s specialist software role. Stuart described the device context, expected standards and risk areas, and confirmed the audit would be a full routine surveillance audit with findings. Niamh’s work is expected to focus on software management, validation, purchasing controls, SBOMs, version rollout and related software risks, with final logistics depending on Stuart’s risk analysis and document access arrangements.

## Key Discussion Points

| Topic | Discussion | Outcome |
|---|---|---|
| Topic 1 | Audit logistics, including hotel reservation, site attendance and travel arrangements for the Sylmar audit. | See discussion |
| Topic 2 | Training and preparation work is due to start the following Monday, ahead of the on-site audit from the 20th. | See discussion |
| Topic 3 | Report writing is planned after the return to Ireland, from 27 July to 7 August. | See discussion |
| Topic 4 | Stuart is leading the audit with Karen, while Niamh will provide specialist software audit support. | See discussion |
| Topic 5 | The audited products include pacemakers, data controllers and bedside transmitters with embedded software and automated monitoring. | See discussion |
| Topic 6 | Initial risk areas include transmission, software rollout, software versions, cybersecurity and related regulatory requirements. | See discussion |
| Topic 7 | No AI claim is expected for the product; the system appears to interpret data through programmed logic and display rather than AI. | See discussion |
| Topic 8 | The audit is a routine surveillance audit with full findings and ratings, not an assessment-style audit. | See discussion |
| Topic 9 | Stuart's main value from Niamh is a deep dive into the software management system. | See discussion |
| Topic 10 | Software audit areas may include software development, validation, purchasing controls, software of unknown provenance, SBOMs and rollout of new versions. | See discussion |
| Topic 11 | Document access may require secure sharing or external access to Abbott's audit SharePoint because Niamh is not on the Abbott network. | See discussion |
| Topic 12 | Code of conduct and training attestation must be completed before confidential audit material is shared or before the audit formally starts. | See discussion |
| Topic 13 | Stuart's risk assessment will feed into the audit plan and is needed before the Wednesday planning meeting. | See discussion |
| Topic 14 | Audit findings and queries will be managed through the audit tracker rather than checklist auditing. | See discussion |
| Topic 15 | SBOM review and CVE/threat checks may depend on what is available on site and on corporate threat-monitoring processes. | See discussion |
| Topic 16 | Niamh may run a separate software track during the second week, depending on Stuart's risk analysis and audit logistics. | See discussion |
| Topic 17 | End-of-day audit coordination is expected to happen after site time or during travel back to the hotel. | See discussion |
| Topic 18 | AI prompts may be used by the audit team to help speed report writing and locate standards clauses. | See discussion |

## Actions

| Owner | Action | Due |
|---|---|---|
| Stuart | Build the audit scope, standards list, classifications, product overview and risk assessment to support the audit plan. | Not stated |
| Stuart | Confirm after the Wednesday meeting what documents can be shared with Niamh before she arrives on site. | Not stated |
| Stuart | Arrange secure document sharing or external SharePoint access for Niamh if needed. | Not stated |
| Niamh | Complete the code of conduct and training attestation before audit material is shared and before the audit starts. | Not stated |
| Jacqui | Send the code of conduct to Niamh today. | Not stated |
| Jacqui and Niamh | Plan Niamh's preparation timeline around Stuart being unavailable while on site from the 14th to the 17th. | Not stated |
| Stuart | Share the risk analysis, audit tracker and available data such as complaints, CAPA and deviations once confidentiality requirements are in place. | Not stated |
| Stuart and Niamh | Hold a face-to-face catch-up at the hotel before Niamh starts the on-site audit week. | Not stated |
| Stuart | Decide whether Niamh should run a separate software audit track based on the risk analysis and logistics. | Not stated |