In a recent interview with Head of Quality, Kirstie Kay, she discusses how TrakCel’s QA team has successfully adapted to facilitate interactive remote audits for clients globally during COVID-19

Kirstie Kay, TrakCel QA Manager

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 schedule.

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 offered on our audit agenda.

TrakCel regularly hosts client audits but in the past three years I’ve been with TrakCel, 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 considered our IT infrastructure and tools

We use Microsoft Teams as our primary communication tool and have the option to use Zoom if a customer prefers.

We considered how Quality Assurance could use Microsoft Teams channels

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. We already use a Trello board to log audit requests. The role of the scribe supporting the audit is a key one to maintain communication whilst the host is presenting screens and answering questions.

We considered the availability of our documentation:

  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.

The audit dates, scope and agenda were confirmed (a 2 day audit).

Document Index List, Quality Policy, Quality Manual and Validation Master Plan sent ahead of the audit.

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 supporting audit attendees. As audit host, I shared a presentation overview of our QMS which was emailed 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 (with microphone muted!) 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.

TrakCel QA

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. We agreed when to pause for breaks and when to stop to give the auditor 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.

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!

So, reflecting on the merits of an interactive remote audit – it was very efficient to host a remote audit.  It required less resource from TrakCel as no security passes, guest Wi-Fi vouchers or food and drink were required.  Quality Assurance did not need to set up an audit room and back room with paper records and files, which meant there was no resource needed post-audit to re-archive records or shred printed SOPs. Not printing SOPs and records was a big time and paper saving!

It is worth noting, as the audit host sharing my screen during review of all procedures, allowing the auditor to read, scrolling down and answering any questions, I was virtually 100% reliant on the scribe for communications back to the team; so a  two-person team is essential for smooth running.

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 for me.  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, but the time difference may present an issue for a US west coast client, so a remote audit may not always be practical, unless you can agree to work outside of core hours.

Overall, if time zones permit, I’ll definitely be encouraging future auditors to consider an interactive remote audit!