“Some things are inevitable during pharmacovigilance audits and inspections; that doesn’t prevent you from preparing!”

In today’s world of information technology (IT) advancement, everyone is talking about artificial intelligence, robotics, automation, and machine learning. It is rather unlikely that things would go wrong during an audit or inspection, more so specifically due to a trivial reason that is related to IT connectivity, network, or even infrastructure. Such issues may last for a few minutes or even many hours, causing inconvenience to both the auditors and the auditees. In rare situations, this may even result in the prolongation of audit dates.  The impact may be higher when it is a regulatory inspection.

When can this happen?

An IT issue may emerge before an audit, during an audit, or even after the audit. The impact is expected to be different based on when it occurs. A little preparation could have helped prevent it!

• Before the audit

The IT issues before the audit are mostly related to network infrastructure, more specifically to connectivity and a firewall. Imagine if the inspector/auditor sent a formal email for audit notification, and that mail did not reach you! As there was no acknowledgement the auditor decided to make a follow-up phone call when you realize having missed something important. Such an error may even occur when a calendar invite does not reach the auditee. At times you would receive the email only but not the attachments. Imagine if the attachments included the list of pre-audit document requests and you have no clue about it until the follow-up phone call, or even escalation!

• During the audit

IT issues during an ongoing audit are more cumbersome as everything is happening in front of your eyes. It might be frustrating when it is a trivial thing, and you don’t have the root cause. An auditor may demand a guest WiFi access especially when they have forgotten their WiFi dongle, or do not have one. Companies generally provide guest WiFi access with numerous restrictions. This might cause inconvenience to the auditors who are unable to access relevant sites of documents. This may apply to document requests (soft copies) during the audit. Besides, the auditee team may find it difficult to demonstrate systems or documents if there is an unexpected downtime. It may even happen due to a planned downtime where the IT team was not notified regarding the audit or inspection.

• After the audit

Yes, the IT issues may even occur after the audit is over. Imagine if the auditor has sent out the audit report but you did not receive that email! As there are strict timelines for response provision, one can anticipate unforeseen reduced timelines for response provision. This can be hazardous especially when there are critical observations.

Remote Audits and Inspections

Imagine a situation where a remote audit was scheduled at 9 AM and it is already 9:15 AM, and the auditee has not joined yet. You decide to call-up the auditee and he/she says “We already joined 15 minutes ago, and were waiting for you!” IT issues are more common during remote or hybrid audits. Again, connectivity may be blocked due to a firewall or there may be frequent disconnections. Testing well in advance helps but is not 100% foolproof.

Avoiding IT issues

Some companies develop an audit and inspection – IT Checklist that covers the possible areas where things can go wrong. At the end of the day, irrespective of how prepared you are, don’t be surprised if an IT issue does occur. That doesn’t prevent you from preparing hard and giving your 100% in preventing any IT issue and having multiple back-up measures during an audit or inspection.