Digital Transformation in Pharmaceutical Quality Management

Digital transformation is the new buzz in industries worldwide, and it has changed the ways manufacturers execute, monitor, and sell their products and services. The pharmaceutical industry also benefitting from digital transformation in its various critical processes, including the quality management system.

Digital transformation helps pharma organizations increase efficiency, speed, and accuracy in their quality operations. Techniques, such as automated systems and data based decisions in quality operations is offering a wealth of advantages, including preventing problems in manual quality processes and management systems, which are currently common in current human-dependent techniques.

What is Digital Transformation, and what are its implications for the pharma industry?

Digital transformation is implementing digital technologies in all areas, processes and departments of an organization. It enables owners to monitor and implement improvements to fulfil their customer's requirements. The main element of digital transformation is automation, which provides new ways to perform routine operations rather than using traditional methods.

Digital Transformation enhances capabilities of existing process capabilities, increasing the productivity of overall system.

Implementing digital transformation is replacing existing manual processes with modern automated systems that rely on software algorithms, artificial intelligence, and machine learning. For this purpose, all the relevant systems, such as IT hardware, personnel expertise, and communication media must be updated in line with its requirements.

Pharmaceutical Industry

The pharmaceutical industry is showing a positive response to the digital transformation, by integrating critical departments and processes with this technology. It allows critical resources, such as equipment, people, raw materials and final product, to increase their capabilities and performance. They do so by using digital tools, such as cloud and IoT, to communicate and share critical information related to production plans, resource availability, supply chain requirements. More importantly, it enhances quality in all aspects of manufacturing and supply chain.

Digital transformation in pharma is designed to achieve pharma-related goals such as efficient production, less wastage, less breakdown, regulatory compliance, quality approvals, and meeting customers' requirements. It helps pharma organizations to micro-manage their decisions and operations in order to optimize both processes and products.

The main ingredient of digital transformation is data, which is used to analyze past, and determine the current status of all processes, which in turn dictates the upcoming and future decisions of critical areas such as maintenance, packaging, warehousing and quality.

Among all of these, digital transformation is also extending its application to quality management, which defines how pharma organizations organize and execute their processes by achieving a higher degree of quality. Traditional practices have focused on manual systems for monitoring, recording data and record keeping, which is prone to problems associated with these manual systems.

How is digital transformation implemented in pharma quality management?

Digital transformation in quality management requires innovative tools that enable quality management to qualify for digital transformation. Let's talk about that.

eQMS

An electronic quality management system (eQMS) is a digital software solution that automates quality processes in a pharma organization at a centralized point. It consists of all the components, such as Corrective and Preventive Action (CAPA), SOP, change management, risk management and quality audit. These components enable pharma quality personnel to perform paperless and automated executions of existing manual processes.

In traditional quality systems, personnel execute processes manually, which often becomes difficult and requires extensive resources such as workforce and records. Manual-based processes can be affected by human errors in monitoring, executing and recording.  

An eQMS enables digital transformation by interlinking discrete quality processes through the use of data-driven methods to streamline the entire product life cycle. It enhances collaboration among all the critical departments, such as production, maintenance, and supply chain, to achieve operational excellence in areas such as compliance, documentation, and change management.

An eQMS can be used to overcome challenges posed by today's traditional methods. It enables an organization to make quality departments resourceful in adapting to change, and utilize data for their processes and compliance requirements without relying on manual systems.

Integration with other systems

System integration is an essential aspect of digital transformation. It connects different software and tools for exchanging information and coordinating with each other.

In a multi-functional environment such as pharmaceuticals, it is not possible for a single software or tool to fulfil each other's requirements. Because every department has a unique requirement that requires distinct tools.

Digital transformation utilizes system integration, allowing different software solutions and tools to exchange data, and convert it into meaningful information of its own.

For quality management in pharma, eQMS can integrate with other system to communicate different departments or processes. Example of such software systems that can be integrated with eQMS include Manufacturing Execution Systems (MES) and Laboratory Management Systems (LMS).  These software are designed and developed to collect and processes data different from eQMS. If other systems do not integrate with eQMS, they will work in solos, and departments will have to switch to manual paper-based methods to share information. Additionally, incorporating these data into eQMS will require manual data entry, which will reduce efficiency, speed, and data authenticity.

Applying system integration in eQMS helps pharma organizations achieve digital transformation in quality by

● Enabling a pharma organization to utilize different separate software solutions for various departments or processes, as per the requirement, without worrying about data management and processing with the quality department

● Allowing pharma organizations to manufacture in different locations or regions, and using a single eQMS.

● Implement a single quality policy throughout an entire facility or multiple facilities.

Data Analytics

Data analytics is the process of critically examining the collected data to extract useful information.  It is a technology related to digital transformation and is implemented with the help of specialized software algorithms that are specially trained to analyze data.

In its simplest terms, they examine data against a set of rules or threshold values and then determine the status of the system being studied. It is the fundamental process of the latest digital transformation techniques that facilitates humans in decision-making.

Data analytics technologies, such as Big data and predictive analysis allow its users to forecast the future trends and state of a given system. It replaces traditional reports and paper-based with real-time analysis, which provides more opportunities for its users in decision-making.

For data analytics, it is necessary to make arrangements for data collection and data storage. Like manual record keeping, data resources such as data centres and servers must be established and maintained.

In pharma quality management, a wealth of data is collected from different processes, such as manufacturing, maintenance, and packaging. Data analytics process these data sets and output their results to improve quality management in the pharma industry, such as identifying gaps in non-compliance and improving these issues. 

Data analytics can help pharma manufacturers improve their quality operations in the following ways.

● Different departments and processes in pharma organizations can collect data centrally, making it easy for quality personnel to access valuable data related to other platforms and tools. It makes it easy for quality personnel to analyze these data and make beneficial decisions. For example, data collected from a manufacturing process can indicate if there are potential problems with a given pharma product batch and if it is on the verge of rejection. 

● Every pharma-related data is critical and provides an opportunity to improve and enhance quality in their routine processes. Data analytics makes it convenient to ensure every data collected is appropriately analyzed (through software algorithms). Data analytics extract valuable information from the noise and make it suitable for quality personnel to make decisions rather than focusing on saving data and analyzing it.

Advantages

Some advantages that digital transformation offers over traditional quality management.

Time - less data collection

One of the most critical aspects of digital transformation in quality management is the ease of data collection.

Without useful product and process data, no quality management can be implemented and succeed. Digital transformation, on the other hand, makes it handy for quality management to collect data without losing any minute detail.

Digital transformation allows various collection points, such as IoT, to collect data, automate the data collection, and store it in a central location. It also provides quality people with the ability to collect data sets that indicate valuable information, such as disruption and deviation about a process or product.

Easy Access

Traditional systems implement a manual paper-based system that is stored in the physical location. Whenever there is a need to analyze or study, it requires a heft of paperwork. Additionally, it also requires dedicated resources, such as room, security and personnel to manage it.

With digital transformation, data can be collected automatically, allowing it to be stored electronically and easily. The data can be easily accessed through software, with appropriate authentication and authorization.

Data analytics provides immediate current status and final result of multiples processes, allowing quality personnel to focus more on quality enhancement, rather than analyzing the data.

Fewer errors

Digital transformation for quality management improves quality in existing processes, and also facilitates those processes in which quality has yet to be implemented. It makes the process easy and maintainable, resulting enhanced compliance in the entire product life cycle, fewer errors and wastage during production. 

About the Author:

Muhammad Asim Niazi

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.