Pandemic problems – effective solutions

The COVID-19 pandemic forced change on every aspect of life, affecting our personal behaviours and our work practices. Unforeseen issues and disruptions to existing processes in clinical trial logistics created challenges that have had long-lasting consequences. The unpredictable nature of these challenges has meant that along the way, we’ve all had to cut each other a little slack. However, there’s one area where there’s not an option – data integrity.

Accurate data is the basis of safe, high-quality end products and it’s the sum of many parts involving people, processes, systems, and procedures, all of which required adaptation during the pandemic – let's look at some examples of the unexpected disruptions that resulted from these adaptations:

• Approval Workflow

Interpersonal interaction has always been a key part of approval functionality. For example, handwritten signatures were a constant feature in review and approval documents. With face-to-face interaction rendered impossible by the pandemic, and software and training yet to be put in place for e-signatures, it sometimes became necessary to print-and-post these often large, detailed documents. Inevitably, errors occurred along the way and ad hoc corrections inserted – in some cases, it was possible that the document signed at the end of the line, wasn’t the same as the one which had been signed at the start of it, rendering it in violation of data integrity principles. This is just one small example of how pandemic operations adversely affected results.

• Ruined Batches

The lack of physical presence of Quality Assurance Personnel sometimes led to a lack of oversight of production processes. Without appropriate supervision, procedures suffered, batches had to be destroyed, work had to be undertaken again – all of which led to delays, higher costs and disruption to the supply chain.

• Delayed Maintenance

Quality systems suffered greatly in some cases due to curtailed or postponed maintenance of elements such as labs and IT systems. Data was accidentally overwritten and, in some cases, lost completely.

• Lessons Learned

When it comes to data integrity, the ALCOA Plus framework is of paramount importance. The pandemic revealed potential pitfalls that could lead to those principles being compromised and the potential ripple effects across human clinical trials. And the one benefit of a pitfall, is that it enables us to devise ways to address it.

Equipped now with increased knowledge of what could go wrong, by working closely with clients to troubleshoot potential problems, effective strategies can be formulated to prevent those problems affecting the integrity of the all-important data. Issues can be investigated fully, and addressed accordingly, getting systems and processes back on track and ensuring that compliance standards are as high as they need to be.

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