Target
Data integrity
Remediation
Location
Brabant-Wallon
Sector
Life Science
Duration
3 years
Budget
Confidential
Team
1 Project Manager
3 Project Engineers
2 CSV Engineers
2 Automation Engineers
Project Context
At the heart of the life sciences sector, our company, which specializes in design offices for Industry 4.0, carried out a project related to data integrity remediation. The objective was the reliability and security of pharmaceutical manufacturing processes, which we pursued throughout the project.
The project involved a wide range of equipment essential to the manufacture of pharmaceutical and biotechnological products. This included cutting-edge technologies such as Dryfog, VHP, autoclaves, isolators and many others. Despite their importance, this equipment was vulnerable to data integrity problems.
Our mission was to remedy these shortcomings in order to comply with current regulations and improve the manufacturing process relaibility.
RealDev's Mission
We offered the customer a complete solution comprising the following elements:
Study
After a thorough analysis of existing problems, we identified several sources of non-compliance that were compromising data integrity. These gaps represented a risk of regulatory sanctions, product recalls and damage to the company's reputation.
Among the problems identified, we found:
°Inadequate data backup and inadequate recovery procedures,
°A lack of audit trail compliant with FDA specifications,
°Inadequate access controls and data validation checks,
°One-time server synchronization.
By working closely with equipment suppliers, we ensured that these solutions were seamlessly integrated into their existing systems, without any disruption to the manufacturing process.
Moreover, we took obsolescence management into account by replacing certain programmable logic controllers (PLCs) and human-machine interfaces (HMIs) with newer versions, fully compliant with regulatory data integrity requirements.
Pilot
Once this study has been carried out, the entire solution, both software and hardware, is implemented in a pilot building. Thanks to this strategy, everyone involved, including RealDev, was able to concentrate on successfully qualifying this building in the field.
Deployment
Thanks to the feedback from the pilot evaluated via After Action Reviews, RealDev was able to further optimize its strategy and implementation. We were in charge of all the design office tasks, including :
-Stakeholder coordination (suppliers, customers, partners, etc.)
-Technical implementation
-Qualification
-Site management and safety
-Training of production & maintenance departments
Don't let gaps in data integrity undermine your business. Rely on our expertise and join us today to benefit from our comprehensive solution that guarantees the integrity of your data and protects your company's reputation.
