pharmaceutical-industry-third-party_history-2

Life Science

Implementation of a Workflow Manager to Standardize Processes

The case study

Sector

Life Science

Customer

Companies within a pharmaceutical group specializing in the production of APIs and medications in the areas of cardiovascular disease and osteoporosis, immuno-oncology, gynecology, thrombosis, critical ischemia, and neurology.

The problem to be solved

Because the client operates in multiple international locations, it had been using non-standardized processes that resulted in different operating procedures from one country to another.

How it was addressed

Phase 1

Analysis

1
Analysis of Headquarter needs
2
Analysis of Headquarter processes
3
Analysis of Headquarter procedures
4
Feasibility study
5
Identification of requirements support
6
Optimised processes design

Phase 2

Digitalisation

1
Activation of catalogue processes
2
Implementation of custom processes
3
Factory Acceptance Test (FAT) of custom processes
4
UAT (User Acceptance Test)
5
Documentation support Corporate and site validation
6
Corporate and site differentiated tests
7
Server and Backup configuration support
8
Initial data loading support

Phase 3

Support

1
Training for the administration of the Corporate system
2
Training for key users and end users for each site
3
Initial (system) setup support for each site
4
Help desk assistance service

Final product

  • Processes implemented
Training
Deviations/Non-conformity
Audit
CAPA
Events/Incidents
Controlled label printing
Management of stability samples
I am interested in

Results

• Gradual digitisation of departments and sites

• Standardisation of operating methods

• Monitoring of the performance of each company in the group

• Facilitated sharing and accessibility of data

• Efficiency of the management of the processes

See also:

Life Science

Implementation of a Workflow Manager to Control Processes

Read more
Life Science

Implementation of a Workflow Manager to Improve Performance

Read more

    Autorizzo ai sensi del GDPR 25 maggio 2018 n. 196 il trattamento dei dati personali trasmessi

    Do you want to see the product in use?

    Fill in the form or call us, one of our experts will get back to you as soon as possible!

    Address
    V.le PL Nervi,
    Latinafiori Tower 4,
    04100, Latina

    Telephone
    + 39 0773 694245

    Fax
    +39 0773 417509

    Life Science

    Implementation of a Workflow Manager to Standardize Processes

    The case study

    Sector

    Life Science

    Customer

    Companies within a pharmaceutical group specializing in the production of APIs and medications in the areas of cardiovascular disease and osteoporosis, immuno-oncology, gynecology, thrombosis, critical ischemia, and neurology.

    The problem to be solved

    Because the client operates in multiple international locations, it had been using non-standardized processes that resulted in different operating procedures from one country to another.

    How it was addressed

    Phase 1

    Analysis

    1
    Analysis of Headquarter needs
    2
    Analysis of Headquarter processes
    3
    Analysis of Headquarter procedures
    4
    Feasibility study
    5
    Identification of requirements support
    6
    Optimised processes design

    Phase 2

    Digitalisation

    1
    Activation of catalogue processes
    2
    Implementation of custom processes
    3
    Factory Acceptance Test (FAT) of custom processes
    4
    UAT (User Acceptance Test)
    5
    Documentation support Corporate and site validation
    6
    Corporate and site differentiated tests
    7
    Server and Backup configuration support
    8
    Initial data loading support

    Phase 3

    Support

    1
    Training for the administration of the Corporate system
    2
    Training for key users and end users for each site
    3
    Initial (system) setup support for each site
    4
    Help desk assistance service

    Final product

    • Processes implemented
    Training
    Deviations/Non-conformity
    Audit
    CAPA
    Events/Incidents
    Controlled label printing
    Management of stability samples
    I am interested in

    Results

    • Gradual digitisation of departments and sites

    • Standardisation of operating methods

    • Monitoring of the performance of each company in the group

    • Facilitated sharing and accessibility of data

    • Efficiency of the management of the processes

      Autorizzo ai sensi del GDPR 25 maggio 2018 n. 196 il trattamento dei dati personali trasmessi

      Do you want to see the product in use?

      Fill in the form or call us, one of our experts will get back to you as soon as possible!

      Address
      V.le PL Nervi,
      Latinafiori Tower 4,
      04100, Latina

      Telephone
      + 39 0773 694245

      Fax
      +39 0773 417509