Nicolas Le Du : Hello, my name is Nicolas Le Du, and I'm currently Sales Director at Factory Software, having been responsible for the Life Sciences market (pharmaceutical and cosmetics industries) for several years. Factory Software is a distributor of AVEVA solutions and pays particular attention to this market, which requires a special approach and construction of offers, particularly in relation to regulatory constraints and the particularities of the business.
Valentin Dugast : Hello, I'm Valentin Dugast, and I'm currently in charge of development and support for Life Science customers in optimizing their production. Factory Software's long-standing focus on this sector has resulted in a large number of references.
Nicolas Le Du : In fact, the constraints have always been more or less the same. One of the main constraints for the pharmaceutical and cosmetics industries is the regulations imposed by the FDA (Food and Drugs Administration) with 21 CFR Part 11. Cybersecurity issues are also becoming increasingly important. Customers need to approach and monitor their applications a little differently from other sectors, to avoid any risk of cyber-attack or data leakage. The market must therefore juggle these cybersecurity constraints, while complying with regulations...
Since then, the stakes have shifted a little with the health crisis, telecommuting, but also in the attitude and production of different industries - typically the cosmetics industry has had to produce more hydroalcoholic gel, and pharma has had to adapt for vaccine production. So there has been a strong acceleration in digital technology to adapt both to telecommuting and to production challenges.
Overall, the biggest challenge facing the Life Sciences market today is to keep up with the digital revolution, so as to continue to produce and adapt to today's needs, while mastering historical regulatory constraints and protecting infrastructures from cyber-attacks.
Valentin Dugast : Companies in the Life Science sector face real challenges when it comes to digitizing their production processes, in order to meet a wide range of requirements: data security, regulatory compliance, interoperability between technologies, production agility and control, cultural transformation, skills management and cost control.
Factory Software, through our AVEVA software, offers several solutions to meet all these requirements. The combination of our solutions and our expertise enables manufacturers to master and succeed in their digital strategy.
Nicolas Le Du : Digital technology is becoming increasingly important, and Life Science manufacturers have no alternative but to deploy it in order to remain competitive. Current trends are therefore mainly focused on the digitization of data and processes. Today, regulations are leading to the implementation of EBR (Electronic Batch Records), enabling efficient documentation of batches and thus “zero paper”. The aim is to provide better traceability of operator actions, production lines, etc., to achieve electronically processed Master Batch Records, with processes and results documented in accordance with regulatory provisions.
Software for traceability of production data, as well as environmental traceability, with EMS (Environmental Monitoring System) solutions, is also gaining ground among manufacturers in the sector. These solutions are important for validating the correct atmospheric conditions in a cleanroom, laboratory or ZAC (Zone à Atmosphère Contrôlée) during production, and for ensuring the monitoring and transparency of production data. AVEVA offers a wide range of industrial IT software, with different types of modules to meet all the needs of companies in the cosmetics and pharmaceutical sectors:
Valentin Dugast : This market is constantly evolving in order to optimize operations as much as possible. In addition to the solutions mentioned by Nicolas, we also find artificial intelligence solutions, data management solutions, and solutions for making data accessible from different locations or devices, while guaranteeing security and regulatory compliance.
The Life Science industry has a real need for flexibility in its technologies in order to adapt to changes. AVEVA Flex meets all these requirements.
Finally, to return to the strong trend of data management, AVEVA offers its AVEVA PI System (ex. OsiSoft) solution, which is agnostic and open, and enables data to be collected, stored, analyzed and visualized to improve a company's operational efficiency. This solution enables you to make 100% use of your data, with a rapid return on investment.
Today, as we mentioned at the outset, the digitalization of production is the race that everyone wants to win. But just because it's a race and everyone wants to get in, doesn't mean you have to do it any old way. There are certain best practices to follow.
AVEVA's strength lies in the fact that we rely on a large network of integrator partners dedicated to this market. These integrators, specialized in the implementation of AVEVA software, are as competent in the product as they are in the pharmaceutical and cosmetics market. They therefore bring with them comprehensive expertise in integrating products to meet market constraints (particularly regulatory constraints), but also customer constraints. In fact, digitalization projects require both external resources (integrators, software) and internal resources, since these are real corporate projects requiring a rethinking of approach and implementation.
To cite an example, an EBR project cannot be set up without strong consultation and integration on the part of the customer, particularly with regard to the presentation of his business processes through working meetings with the integrator.
If I had to share my best practices with you, I'd say that it's not so much from a software point of view, but rather in terms of project management and internal involvement, that you need to focus your project. Building the team that will respond to and support the project will be decisive for its success.