Life Science
Implementing a workflow manager to increase performance
The case study
Sector
Life Science
Customer
Important and historic pharmaceutical company, present in Italy, engaged in the research and development of therapeutic solutions aimed at combating pain and addictions.
The problem to be solved
Some of the strategic processes in the areas of Quality, Governance and Production were not digitised and so performance had not been maximised.
How it was addressed
Phase 1
Analysis
1
Needs analysis
2
Process analysis
3
Analysis of the procedures
4
Analysis of integration with other company systems
5
Feasibility study
6
Identification of requirements support
7
Optimised processes prototype design
Phase 2
Digitalisation
1
Implementation of processes on the platform
2
(FAT) Factory Acceptance Test
3
UAT (User Acceptance Test)
4
Integration with ERP
5
SOP drafting support
6
Server and Backup configuration support
7
Support for digitalisation of paper documents
Phase 3
Support
1
Training for those managing the system
2
Training for key users and end users
3
Initial (system) setup support
4
Help desk assistance service
Final product
Documentation
Training
CAPA
Deviations
Change Control
Complaints from the Market
Batch Record
Quality Risk Management
Results
• Real-time control of the activities of the Quality, Governance and Production areas
• Optimisation of times during Batch Record Review
• Increase in the performance of the strategic processes
• Total compliance with industry regulations
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