Consultancy

System Life Cycle implementation

Customer:

Wholesaler

Period:

2017 - 2018

Location:

the Netherlands; Alkmaar

Project Type:

Validation

Project Function:

SME Computer Validation

   

Description of activities:

A wholesaler is implementing a validation approach for the complete Pluripharm group. In this role I am implementing a System Life Cycle approach for all business units in the Pluripharm group. This starts with defining a lean approach based on GAMP 5 standards, training of stakeholders, creating system inventory, validation of new systems and remediation of existing systems that have to comply to CF, GDS, GMP and GDP regulations.

 

ERP Validation

Customer:

Wholesaler

Period:

2017 - 2018

Location:

the Netherlands; Alkmaar

Project Type:

Validation

Project Function:

SME Computer Validation

   

Description of activities:

A wholesaler is migrating a homemade ERP and WMS system to a new JDE system. In this project I am responsible for the validation of the system. The system is implemented with an Agile project approach.

 

Validation of Document handling system

Customer:

Government organisation

Period:

2017 - 2018

Location:

the Netherlands; Bilthoven

Project Type:

Validation

Project Function:

SME Computer Validation

   

Description of activities:

RIVM is implementing an Document handling solution in the organization, where several departments store GxP critical data and documents. The system is implemented with an Agile project approach. In this project I am guiding the validation of the systems.

 

Validation of production and laboratory equipment

Customer:

Pharmaceutical Company

Period:

2012 - 2013

Location:

Netherlands; Meppel

Project Type:

Validation

Project Function:

Validation Manager

Description of activities:

Within the Pharmaceutical production plant in Meppel production and laboratory equipment I installed or modified.

In these projects I was responsible for the risk-based validation of this equipment.

Aseptic Capacity Expansion

Customer:

Medical Food company

Period:

2012 - 2013

Location:

Netherlands; Zwolle

Project Type:

Validation

Project Function:

Validation Manager

Description of activities:

Within the Pharmaceutical production plant in Meppel production and laboratory equipment I installed or modified.
In these projects I was responsible for the risk-based validation of this equipment.