Applying Predictive Analytics to Document Review Outcomes

Digital transformation has been an initiative at the forefront of the life sciences industry, with companies investing in newer technologies such as artificial intelligence (AI), machine learning (ML), advanced data analytics, and more. When it comes to digital transformation in quality management, few have made significant steps to successfully implement and gain value from these technologies.

While few organizations have been able to gain deeper visibility into their quality systems, many are overlooking a key path to more meaningful insights: Transforming document review processes.

The Power of Document Review Processes

The document review process is a standard operating procedure done at any company that has a quality management system (QMS). They ensure that procedures are being followed and that systems are compliant, and often uncover areas that are not up to regulatory standards.

The traditional way of performing document reviews often leads to valuable information on the health of quality systems going down the drain. In most cases, review findings are never seen again once they are addressed due to unstructured and scattered procedures.

By not establishing a document review system that captures and collects the findings, companies are missing out on actionable insights they could have at their fingertips in real time.

Leveraging advanced technology does not have to be a long and costly transformation. If quality organizations focused on adjusting their document review processes, they could gain deeper visibility into operations and know on a continuous basis which systems are compliant or at risk, processes or events that frequently cause issues, and more.

Two-Step Transformation Process

There are two key steps to transforming this standard procedure and establishing a document review system that removes data siloes and allows for the implementation of advanced analytics.

The first step is creating uniform templates used across all document review teams that capture the information leaders and organizations want to gain insights on. Essentially, there needs to be a standard way to collect the document review process data. You can reference our previous blog post for recommendations on creating effective templates for advanced data analysis.

That collected data is only useful once it is accessible, which is why the second key step to leveraging it is establishing a document review system that captures and holds the information. There needs to be one place where teams can store their findings captured in the templates. This could look like an extension of current quality document management systems or creating a new, preferably cloud-based, platform. This repository of information will be the path to deeper insights.

Gaining Deeper Visibility Into Quality Operations

These two steps remove barriers many organizations struggle with to advance their digital transformation in quality management and allow them to leverage the power of Quality 4.0 technology. Once standard templates are deployed and a platform to hold the information is established, teams can then apply predictive analytics and gain actionable insights.

If quality organizations focus on transforming document review processes, they can get notified of predicted events before they turn into issues. Some of the insights teams could have on a continuous basis include:

• True first-time-right (FTR).
• Risk level (systemic versus other).
• Training effectiveness.
• Group and individual performance.

The possibilities are endless if you can access and leverage document reviews. This two-step transformation could be what your organization needs to take quality operations and performance to the next level. We recommend partnering with industry experts and providers that deeply understand quality operations, the document review process, what it takes to gain value from it, and the technology needed to do so. Imagine streamlining workflows, reducing costs, and improving data visibility by simply adjusting this standard operating procedure.