In the technological universe that nowadays enfolds us, the emerging technologies inherent to industry 4.0 stand for a better and more efficient management and control of quality.

Some figures reflect the impact that these technologies are having for the pharmaceutical industry progress.

The so-called fourth industrial revolution or industry 4.0 implies elements such as robotics, simulation, blockchain, automation, big data. Also, integrated systems, The Internet of Things (IoT), 3D, augmented reality, cloud computing and cybersecurity.

Each of these elements has the power to revolutionize each structure in laboratories and pharmaceutical factories in 10 years from now. This is in line with a study published by McKinsey.

To illustrate the importance of quality management in the pharmaceutical sector, the article of McKinsey highlights some effects of industry 4.0 in terms of productivity and quality:

-In “efficient and mature” laboratories, the digital transformation that includes aspects such as big data, use of robot and implementation of cybersecurity systems, leads to 30% to 40% of increase of productivity.
-In these same environments, it implies a decrease of 50% of the global costs related to quality control.
-The digitalization and automation involve less manual errors and variability, jointly with a more effective and fast resolution of problems and failures.
-In the study of evaluated cases, the industry 4.0 has allowed to reduce in 65% the deviations of production and in 95%, the closure of the production processes.

This leads us to conclude that quality management and the use of 4.0 environmental tools, at present available, may save millions of U.S. dollars or euros in costs, as it has been disclosed by the study.

What must pharmaceutical companies do to optimize quality control (QC)?

If the best technology seems to be available for any pharmaceutical company to reach its quality management goals, why do not all of them achieve said goal?
The truth is that there are several obstacles to be faced.

According to the analysis made by Yan Han, Evgeniya Makarova, Matthias Ringel and Vanya Telpis, there exist pharmaceutical companies that do not envision yet the benefits of this type of technology 4.0 for quality management.

Some other obstacles to be borne in mind and which is necessary to attack are the following:

-The limitations of some quality managers within the company to explain to the high-rank management, with figures and examples of successful cases, the importance of the technological transformation (automation or digitalization) in certain areas of the business.
-The implementation of long-term strategies within the companies of the pharmaceutical sector may lead to invest large amounts of money which benefits are not so visible to the naked eye.

If we are in charge of any pharmaceutical company or if we are part of a quality management department, we wonder, what can we do to raise the chances offered by the emerging technologies for the evolution of our industry?

Experts and advisors recommend:

-To investigate with a magnifying glass the commercial cases of success, in different investment levels
-To set clear objectives and goals with the help of quality management and technological transformation experts
-To set fast pilot testing to evaluate the use of the new technologies that we are willing to implement.
-To strategically invest over the long term in sectors such as I + D to raise the responsiveness and foresight of better testing systems, appropriate for the fast progress of technology.

Three essential items to set our goals

In the future outlook of pharmaceutical laboratories, there are three aspects which need greater attention for a more effective and sustainable quality management.

These three items must be the starting point for the rest of the strategies to be implemented.

Laboratories and data in real time

Nowadays the world moves in real time. So, it is necessary to invest in it.

Today it is possible that a pharmaceutical company may verify its processes, share data among the teams, keep track on trends, prevent deviations or changes in the execution of specifications at the same time they occur.

At present the laboratories with state-of-the art digital technology may have tools such as smart glasses, advanced analytical platforms and IoT, personalized twins and software with specific laboratory programs.

All the necessary technology exists and allows to execute the procedures down to the last detail, in a standardized manner, and hence avoid or prevent impacts.

Reduction of energy expenditure and less waste

Nowadays humanity demands industries that use cleaner technologies.
Pharmaceutical laboratories may be in the lead with less-polluting systems, thanks to robotics, the more effective management of information and other advances in industry 4.0.

At present it is possible, for example, to reduce up to 80% or more the requirement of paper in the laboratories that have invested properly in their digital transformation.

In such sense, the regulations are added to give a legal nature and protection to elements such as the use of electronic signatures, instead of signatures in paper, something that has been recently contemplated in the CFR21 or the Federal Regulations Code.

Quality and major savings

A good quality management in a pharmaceutical company involves procedures that allow to optimize savings.

Hand-in-hand with industry 4.0, at present it is possible that a laboratory in which its management has invested in its digital transformation, may achieve considerable cost reductions.

For example, the costs may be reduced from 15% to 45% in quality controls. This depends on the type of laboratory and the role they play in the company.

5 key steps to improve quality management

If you want to improve Quality Management in the company devoted to the pharmaceutical and health sector, you should bear in mind these 5 steps.

1. Before definitely choosing a technology, it is important to test several uses and the integration form of said technologies. To establish the laboratories that serve as headlights to measure different quality controls may help to find the final system.

2. The optimization of the programming systems is an excellent way to achieve faster said way to the technology that best suits our business. This type of tools with specific software or programs may be displayed in several parts to measure which technologies may work and which may not.

3. To mark the goals in a transparent and individualized manner for each department or laboratory, eases technological decision-making and more savings of time and money.

4. The preparation of the human resource from the beginning and the abilities that he/she must handle to respond to the company’s future needs is essential for quality control. The company must invest in frontline staff’s update and hire new talents that already have the abilities associated to industry 4.0, such as big data analysis, use of IoT, robots or automation technologies.

5. To resort to the hiring of experts’ support systems who, remotely carry out the maintenance and monitoring of the automated equipment within the laboratory and plan predictive tasks, helps to optimize quality management.

To obtain more information on the impact of the companies’ digital transformation in this decade, you may review the recommendations and balance sheet of the Firm PwC on the behavior of industry 4.0.

As we have seen throughout this e-book technology 4.0 is a cornerstone to lead pharmaceutical companies to success. It allows them to evolve hand-in-hand with a world that changes ever faster.

Fortunately, unlike what happened one decade ago, all this technology is available to simplify the processes and include the tracking, the participation in real time of production lines, and at the service of the pharmaceutical industry quality management.