Location
Braban-Wallon
Sector
Life Science
Duration
Closed
Team
1 Project Manager
1 Project Coordinator
2 Automation Engineers
Project Context
At RealDev, we firmly believe that every challenge represents an opportunity to innovate and create sustainable solutions. Recently, we had the honor of collaborating with a leader in the pharmaceutical sector on a large-scale project aimed at addressing gaps in data integrity on dry fog sterilization equipment. This journey, full of creativity and advanced technology, allowed us to push the boundaries of what is possible.
It all started with a realization: our client's dry fog sterilization equipment had significant gaps in terms of data integrity. The task was clear but ambitious: to design an innovative solution capable of reliably and securely capturing and centralizing the data. Our challenge was to integrate a robust solution in 8 production units, encompassing 200 pieces of equipment.
RealDev's Mission
This is where the expertise of our design office came into play. We developed a revolutionary PLC concentrator capable of collecting data from ten pieces of equipment simultaneously and, most importantly, compatible with all types of dry fog on the market. This agnostic solution, in addition to its versatility, with IT/OT standards and strict cybersecurity requirements, thereby ensuring optimal protection of our client's critical data.
Phase 1 - technical study
Following an in-depth examination of existing GAPs, we identified several data integrity issues that threatened regulatory compliance, risking product recalls and reputational damage.
Key issues identified are:
- Inadequate data backup and recovery procedures
- Lack of FDA-compliant audit trails
- Insufficient access controls and data validation checks
- One-time server synchronization
Phase 2 - Pilot
Once the analysis was complete, we implemented the entire solution, encompassing both software and hardware, in a pilot facility. This strategic approach allowed all stakeholders, including RealDev, to focus on successfully qualifying the facility in a real-world setting.
Phase 3 - Implementation
Building on insights gained from the pilot phase through After Action Reviews, RealDev further refined its strategy and execution.
We managed all aspects of the design process such as:
- Coordinating stakeholders (suppliers, clients, partners, etc.)
- Technical implementation
- Qualification
- Site management and safety
- Training for production and maintenance teams
Phase 4 -Project Closure
- Training of production & maintenance departments
- Creation of a user guide for the new practices implemented
- After action review meeting and handover with the client
But our innovation didn’t stop there. We also integrated this solution into PI Vision, allowing supervisors to view sterilization cycle results in real-time from any desktop PC. This functionality transformed production processes, offering unprecedented transparency and responsiveness. Now, teams no longer need to wait for the end of a cycle to know the results, which significantly improves efficiency and decision-making.
This project, conducted with passion and rigor, demonstrates our commitment to providing cutting-edge solutions tailored to the specific needs of our clients. At RealDev, we are proud to contribute to the evolution of the pharmaceutical industry by offering innovations that ensure the reliability, security, and performance of operations.
Do not let data integrity gaps undermine your business. Trust in our expertise and partner with us today to leverage our holistic solution, safeguarding your data integrity and protecting your company's reputation.
