Before a drug can reach the market, it goes through several development and research stages. Below is a high-level view of the drug approval life cycle.

Throughout this entire process, immense amounts of data are collected. However, collecting data is only a small piece of the puzzle: the true value lies in deciphering, analyzing, and reporting the data. One of the key items in this task is the ability to identify trends.

The Importance of Trend Analysis

What is the value of identifying trends in your data? Although you want to discover any issues with your processes before a federal auditor is knocking on your door, this shouldn’t be your main motivation for being proactive.

Viewing irregularities in your data readily can help you implement strategies to fix your procedures, which can improve batch production and/or testing. On the other hand, you can also pinpoint areas your business is doing well. Understanding your strengths allows you to implement them across the organization. The ability to isolate data points and investigate the reason behind failures or successes is crucial to drug approval. This data allows you to generate the following outputs:

• CAPAs
• OOT Reports
• Deviations
• Change Controls
• Reinforcement Training

This process of collecting and analyzing data, combined with the ability to implement action items, can all be carried out using the advanced QMS platforms available today.

Leveraging eQMS Platforms in Trend Analysis

Did you know that, while most pharma companies have an electronic Quality Management System (eQMS), they rarely leverage their system to its full potential? According to a report [can view the report here] from Master Control, only 29% percent of companies with an eQMS have fully integrated the system into their processes. This means most companies still operate on a hybrid digital and manual data tracking model. Having different sources of data can truly affect a company in the long run due to not having a consistent “source of truth.” Below you can find some of the plethora of benefits that come with a fully integrated eQMS:

• Single repository of data
• Streamline workflows
• Tracking and analyzing metrics
• Audit facilitation
• Automation

(The above benefits are data focused. Indirect benefits of an eQMS can be cost-savings, easier training, and accessibility for employees.)

Regarding trending data, an effective eQMS allows you to access up-to-date data to make effective business process decisions quickly. A snapshot of how a drug progresses is imperative for continuous improvement. If you are unable to monitor your status effectively, how can you understand which actions lead to improvement? Trend analysis is essential to know where you stand regarding your strengths and weaknesses. The ability of today’s eQMS platforms to provide this measure of self-awareness is unprecedented; they can provide real-time data across multiple software, such as laboratory information management systems (LIMS) and manufacturing enterprise systems (MES). It lays everything out in view, so decision-makers can gather and manipulate information quickly, ensuring an expedited response time to issues and concerns.

Looking Towards the Future

Trending data is only one task made exponentially easier with the advancement of QMS platforms. Post-covid has introduced a new era of regulatory planning. With an effective eQMS, audits can be performed remotely and still comply with standards, such as 21 CFR Part 11. Hopefully, as more firms take full advantage of the functionality offered by eQMS, the whole industry will take note and start fully implementing these tools. This way, breakthrough drugs can make it to market sooner and help patients in need.

Here is another blog from 2021 on Trend Analysis.