Antiksha Joshi

The pharmaceutical and wider life science industry is slowly but surely moving toward Industry 4.0. This is evidenced by the regular entry of new and improved equipment, monitoring systems, and electronic quality management systems into the market, as well as the increased number of regulatory publications on the same.

Organizations are increasingly adopting and implementing software-based and automated solutions for many of their quality systems as well as manufacturing processes. The most common, and often the first system any organization implements, is an electronic Quality Management System (eQMS).

Choosing and implementing an eQMS

When choosing and implementing an eQMS, the organization's sole purpose is to reduce human errors and improve efficiency. Once an eQMS is implemented and in use, it is often found that problems have not been resolved, and efficiency has only marginally improved.

Often, the QA department is blamed for implementing an eQMS that doesn’t seem to have made execution any easier. Over time, problems are fixed, issues resolved (mostly through upgrades and change controls), more training imparted, and the system finally seems to work as intended. In this process, however, valuable resources are spent, both time and money.

So, why does this happen? The number one reason, in my experience, is that there is a lack of understanding between a process and a tool. All electronic systems and automated technologies are just tools that help your work become easier, leaner and more efficient. And like all tools, they are only as good as the process for which they are used. In subsequent paragraphs I elaborate a little more on this.

Process VS tool

The dictionary definition of a process is “a series of actions or steps taken in order to achieve a particular end”. Applying this definition to the different elements of a QMS (e.g. document management, deviations, change management) means that every organization has established a series of actions that need to be taken to achieve the desired result (including regulatory compliance). This series of steps/actions is the process for that element.

Let us take an example of document management. The process of document management normally involves the following steps:

1. Document generation (Drafting, writing, updating)
2. Document review
3. Document approval
4. Document issuance/distribution
5. Document archival

Every company will establish different ways in which the above steps of the process are executed, based on the nature of its operations, size, staff competencies etc. This can be easily represented using a process map or flow chart that also highlights inter-related steps/functions. This is what a document management process refers to. In a regulated industries, like ours in the life sciences, it is also important to take into consideration data inputs/outputs and data integrity controls of this process.

Now, the definition of a tool is “a device or implement, used to carry out a particular function/task.” Hence, the eQMS is a tool that is assisting a company in performing the various tasks associated with its document management. This electronic tool makes the process easier to manage, reduces manual errors as well as improves efficiency.

eQMS – a valuable tool but not an instant fix

Many organizations implement an eQMS without first clarifying or understanding their QMS processes and how they flow. Without this clarity, the company is either reliant on the process flow designed by the eQMS provider, or continuously needs to change and upgrade the system as users find issues during execution of tasks.

To meet compliance requirements, these changes need to be documented, and re-validated if required, leading to more time and resource expenditure. For the QMS, this issue is further complicated by the fact that though QA is the owner and responsible for implementing QMS elements, the inputs for each of the elements come from all other departments.

Hence, a clear understanding of the process flow for each QMS element and the involvement of other departments is a crucial first step in the implementation of digital and electronic solutions.

This is not to say that a company must always purchase expensive bespoke versions of an eQMS. What it implies is that the organization has better clarity on what the requirements of its system should be, can compare its process flow with the service providers’ system, identify areas that may need modification (either in the system or in the company’s process) and then begin the implementation process. This helps:

• Select the most suitable service provider
• Proactively identify areas that require additional validation, controls, procedural changes
• Reduce time and money spent on upgrades
• Improve employee acceptance and engagement with the system

Conclusion

Understanding the difference between a process and a tool is the foundation for implementing effective electronic and automated solutions. It not only provides visibility of the steps involved, makes comparisons easy, ensures the implemented system is compliant but also ensures there is increased buy-in and faster adoption of the tool by employees.

So, in conclusion, effective implementation of any electronic, automated or digital solution requires clarity of the various steps involved in the business operations it aims to support (whether QMS, Inventory management, manufacturing operations, analytical testing). Process mapping and training have to be the first action of a digitalization strategy.