Automation in the Pharmaceutical Industry: Streamlining Statutory Reporting Procedures

Nov 8, 2022

The pharmaceutical industry is one of the most heavily regulated industries. While this means that the potential for business growth is limited to a certain degree, it also ensures that manufacturers are always abiding by strict standards and regulations. To remain compliant with these rules, manufacturers need to ensure they’re producing the correct documents and reports at the appropriate time throughout their production process. Failure to do so could have serious implications for profitability and even brand reputation. To achieve this, manufacturers can turn to automated solutions for statutory reporting procedures as part of a wider digital transformation initiative. In this blog post, we’ll investigate more detail about how automated solutions can help you streamline your statutory reporting procedures in your pharmaceutical company. 





What is a Statutory Reporting Procedure? 


A statutory reporting procedure, also known as a statutory report, is a type of report that pharmaceutical manufacturers produce when they want to inform their government regulators about the status of their current manufacturing processes. There are two types of procedures – continuous and batch.  


  • Continuous procedures are used to keep the regulators informed about the status of a process without any break. This is usually the case with fluid-bed granulation, fluidized bed roasting and fluidized bed coating.  


  • Batch procedures, on the other hand, are used when a process must be stopped and restarted again. This is mostly the case with product formulation and filling. 



Why is Automation Important for Pharmaceutical Manufacturing? 


Automation is key for any company operating in the pharmaceutical industry. You’re already working with large volumes of highly regulated materials, so ensuring you meet regulatory requirements at all times is absolutely essential. When production is manual, many of these procedures are highly time-consuming. It’s also difficult to keep track of the required documentation and when it needs to be produced. With a fully automated system in place, you can drastically reduce the time it takes to produce these documents. This means less time-wasting production bottlenecks and less risk of missing any regulatory deadlines. 



The Importance of Automated Tracking and Compliance Software 


Automated tracking tools are designed to track the entire production process. By monitoring the status of each and every product, they can notify users of upcoming government reporting requirements. By having this information in advance, compliance officers can ensure they have all necessary documentation available at the right time.


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This process is known as tracking if compliance, or TIC. When production is manually controlled, it can be incredibly difficult to keep up with the status of every product. This is especially true when you have a large number of products in the manufacturing process. This can lead to inaccurate reporting and even violations, which can have a serious impact on business growth. Automated tracking software can help you avoid these issues and provide a more accurate representation of your production timeline. 




Benefits of Automation in Statutory Reporting Procedures 


  • Reduction in Errors – When completing these procedures manually, there is a considerable risk of human error. Incorrect data can lead to inaccurate reports, and this can seriously disrupt production. With automated software, you can drastically cut down on these risks.


  • Streamlined Production Process – When production is manual, it’s easy to get stuck in bottlenecks. When this occurs, it can be difficult to meet government reporting deadlines. By automating production and reporting, you can reduce the risk of these bottlenecks and streamline your production process. 


  • Improved Compliance – In the pharmaceutical industry, compliance is everything. It’s crucial to ensure you’re producing accurate reports and adhering to the regulatory standards at all times. Automation can help you stay compliant and produce accurate reports. 





The pharmaceutical industry is heavily regulated, and reporting procedures are an essential part of this. By automating these procedures, manufacturers can streamline their production process and ensure they’re meeting regulatory requirements. As such, automation is a crucial part of any pharmaceutical manufacturer’s digital transformation strategy. However, it’s important to find the right software for the job. Ideally, you should find compliance software that has been tailored to fit the needs of the pharmaceutical industry. This will ensure that it has all the necessary features required to automate statutory reporting procedures.