Corrective and Preventive Action in Pharmaceutical Industry

Getting it right the first time in the pharmaceutical industry is an absolute priority. 

If that seems obvious, it’s because it is. 

More so than in other industries, small errors have the potential to cause enormous problems down the line. This is true of large and complex scientific miscalculations, and smaller mistakes alike. In fact the errors which are likely to have the largest impact are human ones: misread handwriting, incorrect calculations, and even mis-written data.  It is imperative that any mistakes, or potential issues, can be identified immediately and acted on, to reduce their later impacts and cut wasted money, resources and time. 

The good news is that there are steps you can take to maximize your success rate and alleviate the likelihood of errors in the first place. 

When the stakes are so high, having a robust corrective action and preventive action (CAPA) plan is the difference between success and failure. And after investing in a new project, it’s important to have a CAPA plan which supports a vision of success. 

What is CAPA?

Corrective action and preventive action, or CAPA, is a methodology for reducing errors and creating robust systems that work smoothly and accurately. 

Corrective action is the means by which problems are resolved when they occur. Identifying a problem swiftly and working to resolve it is part of corrective action.

Preventative action in the pharmaceutical industry is the second part of the puzzle: creating processes whereby errors are less likely to occur at all. After identifying an issue, putting steps in place to ensure that this issue does not occur again is preventive action.

How to make CAPA work for your organization

CAPA is a crucial part of pharmaceutical sciences and an aspect of each part of the industry process, from research and development to accurate marketing and distribution. When a patient is at stake, the pressure to get it right at every stage is huge.

For this reason, there are reams of information available about CAPA methodology. Many hours of time has gone into pondering the best ways to use corrective action plans and preventive action in the pharmaceutical industry,

All of them rest on one crucial aspect: visibility.

Having visible systems and workflows is the first step in any CAPA plan. How can you effectively investigate an issue if you are not sure what the issue is, or whether indeed it is happening at all? What steps can we use to prevent an invisible problem occuring again?

Introducing methods of visibility into your system is the first step in making CAPA work in your organization.

From Paper to Digital

Fortunately, visibility is now easier to achieve than ever before by moving from paper records to digital.

Paper based records are riddled with issues, and finding errors is a laborious and time consuming task. Imagine sifting through thousands of sheets of paper to discover an error was in fact a miscalculation or a mis-reading. Providing detailed descriptions and recording all the information necessary on paper is also a huge burden. When completing manual activities with paper work instructions, information only has one input: the writer. 

With digital records, the writer is not the only input. Now a system can capture data and the user is augmented with the system. 

Digital records automatically capture key data, and safeguard user entry. The system can enable data capture, any users can complete their activities, while the system records the data. Work instructions and user activities can be completed, and the system ensures the right activities are done, the first time: Right first time execution. 

Moreover, digital records provide visibility that is impossible to achieve in traditional paper records. 

With data stored digitally, information can be tracked and trends identified. The systems acts as the reviewer with Review by Exception and errors can be visible easily to the people who need to see them. Further, deviations are identified in real-time to enable real-time corrective action, before the system leaves steady state. With easily configurable workflows and no need for lengthy troubleshooting processes, corrective action and preventive action can be taken immediately.

Finding the right digital solution: OpsTrakker

The best digital solutions have been created with corrective action and preventive action methodologies in mind, such as the OpsTrakker eLogbook and eForms solutions.

Building on more than 25 years of pharmaceutical industry experience, OpsTrakker creates the right solutions for excellence in pharmaceutical, biotech, and cell and gene manufacturing. OpsTrakker eForms augment manual activities with electronic workflows to ensure accurate results with the operator in mind. No longer do users need a paper and pen to complete their activities. Instead, all workflows and assignments can be completed from an iPad or tablet. Fully compliant with 21 CFR Part 11 for electronic signatures, OpsTrakker ensures all activities are properly signed for, and all documentation is available for review.   

Highly configurable workflows are easily adaptable into every team. Plus, reduce your carbon footprint and paper waste, to help move your business towards a sustainable future.

But most importantly, they offer unparalleled visibility.

OpsTrakker digital solutions make visibility simple by enabling a high degree of accessibility to electronic records. They make sure the right information is available to the right people at the right time. All the data is stored in one central digital location and is accessible around the clock. No more misplaced logbooks, or lost forms, OpsTrakker is safe and secure. Our solutions offer unrivaled increases in operator efficiency by recording important information automatically.

Optimize your corrective and preventive action plan now: don’t leave it till it’s too late.