Consultancy

Serialisation

Customer:

Pharmaceutical company

Period:

2015 - 2016

Location:

the Netherlands; Haarlem

Project Type:

Validation

Project Function:

SME Computer Validation

   

Description of activities:

A pharmaceutical company is implementing an OptelVision serialisation solution in the packaging department. In this project I am responsible for the validation of the systems.

 

Laboratory Information Management System

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 a Laboratory Information Management System (LIMS) and an Empower system is updated to a more recent version.

In this project I am responsible for the validation of the system during the project phase. For the operational phase an approach is developed to keep the system in a validated state.

Electronic Batch Record implementation

Customer:

Pharmaceutical company

Period:

2010 - 2011

Location:

the Netherlands; Meppel

Project Type:

Validation

Project Function:

Validation Manager

   

Description of activities:

At a pharmaceutical production site an Electronic Batch Record system is introduced, based on the Werum PAS-X software. The system is integrated with a LIMS system and with SAP.

In this project I am responsible for the validation of the system in the project phase. For the operational phase an approach must be defined and introduced to keep the system in a validated state during the system life cycle.

 

Requirements definition of a MES system

Customer:

Flower Factory

Period:

2006 - 2007

Location:

Netherlands; Renesse

Project Type:

Consultancy

Project Function:

Consultant, Project Manager

   

Description of activitiesISA95GlobalActivityModel

Define the URS for a MES system for a flower factory. ISA-95 was used to structure the system. Together with the owners, managers and operators, the requirements were defined.