Validation is a process that, for many companies, remains manual despite having high costs, causing errors, and being crowded with inefficiencies.   

In this blog post we’ll share how to improve your validation process efficiency by moving to digital validation.   

Challenges of Manual Validation  

Let’s get started by taking a closer look at what we believe are the challenges of manual validation. 

Manual analysis of validation files can be time-consuming since data must be analysed through word processing documents or spreadsheets or even paper.   

Secondly, paper-based workflows are costly. Not only because paper is expensive, but also because of the printing and copying costs, as well as storage and safe disposal costs.   

Typically, it’s also poorly standardized. It is challenging to maintain high-quality data and follow a consistent best-practice structure in compliance with required regulations. Which shouldn’t be a surprise when we rely almost solely on people and manual processes.  

The immediate consequence of that is that it causes major concerns regarding data integrity. We have to trust that the reviewers will not miss anything. But errors will be inevitable.  

Why you should digitalise your Validation process  

Digital validation can help you to:  

  • Reduce time and inefficiencies of validation process   
  • Save costs and improve data accessibility   
  • Enforce consistency and compliance  
  • Improve data integrity   

Let’s go through each of them.  

Reduce time and inefficiencies of validation process 

Reducing time and inefficiencies of the validation process has the potential to generate substantial gains at team and business management level.  

The first way that Digital Validation does so is by applying Machine Learning algorithms that can search, sort, and analyse the data out of digital documents. This means you can identify issues automatically and, naturally, more swiftly.  

The second is through the use of Digital Workflows. You can simplify electronic signatures and create real-time alerts to reviewers pointing out the tasks to complete.   

Save costs and improve data accessibility   

Saving costs by paper-based workflows elimination and improving your data accessibility through digitalization can have a big impact on your company’s organizational and financial success. 

It’s not just that paper is expensive. What costs money are all the resources you need to fill and manage the paper. To print, archive and securely dispose of them, not to mention the time spent searching for some specific file during inspections or audits.   

Through digitalization, data is securely archived in easily accessible digital repositories. This way, all the resources that were needed can be allocated to more important things.   

Enforce consistency and compliance 

Next we have two of our favorites: consistency and compliance. Two important aspects that certainly sound familiar to you in this highly regulated industry.    

How can digitalization help you with that, you ask?  

Firstly, a digital system allows you to set business rules and automated workflows with pre-defined approval requirements and thus force standardization and good documentation practice (GDocP) compliance.  

Secondly, you are always ready for an audit because with a few clicks you get a complete archive of digitized records with fully automated, system-generated audit trails. Remember, you need to fulfill the requirements of both EU and U.S. good manufacturing practices (GMP), including EU Annex 1 and FDA 21 CFR Part 11.  

Bring in data integrity   

Just imagine an incorrect entry of an equipment parameter into validation reports. What do you think will happen? One thing we know, it will be nothing good! 

By automatizing the validation process, you obtain the data directly from the equipment or instruments. This means reliability and it means you can minimize (or even eliminate!) human error.  

Moreover, you also improve the integrity of your data by having it all centralise and securely store according to your corporate record retention policy. 

Ready to move to Digital Validation?   

If you have interest in digitalising your validation process, we can support you. Take a look at our 4TE services and if you think we may be able to help you out, don’t hesitate to contact us.