Target
Data Integrity Remediation
Location
Belgium
Sector
Life Science
Duration
6 months
Team
1 Project Manager
1 Project Coordinator
1 Automation Engineer
Project Context
RealDev was approached to optimize production processes in order to enhance their reliability and decrease the likelihood of errors by implementing a more robust system for maintaining data integrity.
RealDev's Mission
RealDev has been entrusted with the responsibility of spearheading the necessary actions to bring the Project to a successful implementation:
Project Closure
- Training sessions for the production & maintenance departments
- Development of a comprehensive user manual for the newly implemented procedures
- Conducting a post-implementation review meeting and client handover
Implementation
- Collaboration with diverse stakeholders (suppliers, end-users, subject matter experts)
- Conducting follow-up meetings, investigative sessions, and monitoring KPIs
- Implementing technical solutions
- Executing protocols, updating documentation, and preparing reports for validation
- Overseeing safety aspects of the intervention
Project Initiation
- Starting the project by assessing the required planning and resources
- Analyzing the impact of the documentation
- Outlining a validation plan
Technical Study
After a thorough examination and on-site inspection, we have identified instances of non-compliance and proposed resolutions:
- Introduction of a notification alert for each adjustment made to critical parameters on the machine
- Incorporation of a tracking log to periodically review these alterations
- Multiple discrepancies in access management and data integrity between system documentation and software have been rectified
RealDev's extensive background and proficiency are playing a crucial role in raising the bar for data integrity standards, resulting in a substantial decrease in the potential for instances of non-compliance.
