QA Team Spotlight -Adapting to change: Client Audit Support During COVID-19

As a software company, our teams regularly work from home, but never all at the same time!

When lockdown was looming in March 2020 due to COVID-19, TrakCel trialled the entire office working from home with no issues. We then enacted our Business Continuity plan and closed our Cardiff offices. At that time, TrakCel had several client audits booked into our audit support schedule. As an organisation we pride ourselves on being accessible and offering customers a high level of audit support as in a highly regulated industry where quality, safety and privacy are critical, this process needs to be made as easy and efficient as possible for customers to complete.

For the first scheduled audit, TrakCel offered the auditor the opportunity to perform an interactive remote audit. The auditor accepted as in early April the lock-down looked to be in place for some considerable time, and the project was continuing remotely. It does seem some auditors are reticent about interactive remote audits but, as a fully electronic company with cloud hosting, there is no site tour needed on our audit agenda.

TrakCel regularly offers clients audit support throughout the audit process but historically, every customer or consultant has requested to be on-site; so we ran through our existing audit plan and checklist to determine how we would need to adapt.

We had a number of remote working and collaboration tools already in places such as Microsoft Teams and Zoom for online meetings and Trello to log requests. We considered how Quality Assurance could use Microsoft Teams channels to communicate with a virtual ‘back room’ and Subject Matter Experts.  Subject Matter Experts could join the Teams meeting when required. The role of the scribe supporting the audit is a key one to maintain communication whilst the host is presenting screens and answering questions. Our business also utilizes a variety of electronic recording and logging tools which meant that presenting evidence virtually was relatively simple.

1. TrakCel Policies, Standard Operating Procedures and Forms are available electronically in our Formpipe X-Docs Electronic Quality Management System (EQMS).
2. Training records are available electronically in our EQMS.
3. Quality records such as CAPA are available electronically in our EQMS.
4. Project records are available electronically in our EQMS.
5. All our archive paper records are scanned to PDF so are available electronically in our EQMS.

We trialled communications ahead of the two-day audit with the auditor to ensure there were no technical issues. On Day 1, the usual introductions took place on camera between the auditor, audit host, audit scribe and wider audit support attendees. Our audit host, was able to share presentations and as required, email them to the auditor to retain. TrakCel shared screens throughout to display procedures and records.

Subject Matter Experts (SME’s) were messaged to let them know when we were approaching their topic. The advantage of joining via Teams is the SME’s can join the audit without disrupting the existing conversation and wait until needed.  With the auditor’s permission, we also recorded some of the technical sections of the audit, so managers could use these recordings later as a learning opportunity with their team.

SME’s were able to share their screen and demonstrate to the auditor how our Application Lifecycle Management system works to give full traceability and show ‘live’ examples of code review within our software repository. The reporting tools that TrakCel’s software provides may also facilitate remote audits for its customers; providing electronic chain of identity and chain of custody records which can be reviewed via screen share.

The audit ran to time including breaks and pauses to give the auditors time to evaluate their notes. The SMEs were invited to re-join the Teams meeting for the audit closing meeting. The auditor concluded they had covered everything on their agenda and had “drilled down” sufficiently within our systems to conclude a satisfactory outcome. TrakCel received feedback later via the project team that it was one of the best audits the auditor had completed, which was fantastic to hear!

When the audit report was received, it was uploaded to the EQMS. Any findings or recommendations are also documented electronically in the EQMS.

TrakCel had another audit a week later and followed the same plan, with another successful outcome.

So, reflecting on the merits of an interactive remote audit – it was very efficient to host a remote audit.  There were other benefits such as less travel cost, les space (no audit room and back room with paper records and files), which meant there was no need post-audit to re-archive records or shred printed documents which also resulted in a lower environmental impact!

The audit team and SME’s from TrakCel were still able to establish a personal connection with the auditor, although meeting face to face does allow for more social interaction and sharing industry anecdotes over lunch and making a coffee, which always makes an audit more interesting.  From the auditor’s perspective the time to travel and cost to stay for several nights was avoided. This is a significant factor as budgets get squeezed.  Both our auditors were UK based, initially, it was thought that the time difference may present an issue for a US west coast clients but we have sine managed a number of international ‘virtual’ audits successfully.

The TrakCel Quality team is led by John Darch, TrakCel’s Head of Quality, for details about job vacancies within the team browse our career portal.