DryFog eDI remediation

For the biopharmaceutical industry

Location

Braban-Wallon 

Sector

Life Science 

Duration

Closed

Team

1 Project Manager

1 Project Coordinator

2 Automation Engineers  

Project Context

RealDev was solicitated to enhance the reliability and security of pharmaceutical production processes and reduce the risk of errors by a higher robustness of data integrity and to ensure regulatory compliance. The chosen solution was rolled-out over 8 Manufacturing Units containing 200 equipment.

RealDev's Mission  

RealDev was chosen as Automation Engineering Office to carry out the following phases:

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

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.



Want to find out more?

Contact us today to discuss your upcoming project and discover how RealDev can help you achieve your Industry 4.0 ambitions effectively and successfully.  

DryFog eDI remediation
Younes Boukamher June 11, 2024
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