Insatech Pharma our way of working in pharmaceutical project managementIntroduction

All businesses wishing to secure a continuous development, regardless of industry,  will at some point need to manage projects to take up new information, technology, methods, etc. It cannot be stressed enough how important proper project management tools and skills are for the success and up-take of a solution. Therefore the use of recognized project models, along with industry knowledge is of great importance. With more than 25 year in the industry and vast process knowledge, we have just that.

Contact our experts at Insatech Pharma for more information about project utilization, customization, implementation and price. 

How We Work With Pharmaceutical Project Management

At Insatech Pharma we highlight the importance of a good relationship between project customer and project supplier, in order to foster cooperation and transparency throughout the lifetime of the project. Our experts ensures the work flow and process by working according to recognized standards, for which we have gained the ISO 9001 for management system certification by Bureau Veritas. 

Working According to GAMP

Insatech Pharma executes projects according to the V-model, a Good Automation Manufacturing Practice (GAMP) model.

In accordance with the V-model Insatech Pharma works with 7 project phases, each of which is terminated with a milestone. The milestones are critical to project success as they work as individual check points used to evaluate the projects deliveries and activities continuously.

Focus on Project Deliveries and Activities

The project model contains the following main elements that are carried out across all 7 phases of the project: 
Demand control - and change alteration handling, configuration control, measuring and analysis, as well as quality control. 

In each project phase Insatech Pharma produces a number of deliveries such as documentation, prototypes, etc. to test and continuously ensure project validity. We are very careful with providing a sound basis for approval before continuing into the next project phase.  

To ensure optimal project execution we use the V-model activity list as focus points. In the first project phases it means focusing on project descriptions related to design and system, as well as the requirement specifications of the project or solution. In the last project phases the focus of activities shift to project installation and tests.  

Testing and Specifications 

While the scope and degree of project sophistication may vary greatly, testing and prototyping are an integral part of Insatech Pharma’s project work. We secure the termination of activities by tests approved by the customer and for instance perform the following: 

FAT = Factory Acceptance Testing
I/O = Input/Output Testing

SAT = Site Acceptance Testing
TOC = Take Over Certificate

Project Progress and Costs 

In these types of collaborative projects Insatech Pharma makes sure that you as a customer or supplier are made aware of the project progress. This includes project status, budgetary progress, sunk costs etc. It is important at Insatech Pharma that information is kept transparent and shared between stakeholders through out the project. This way a continuous flow of knowledge is secured. 

It is possible to stop projects before completion at any given milestone, it must however be an active choice of the stakeholders based upon the project knowledge and incurred costs. 

If you are interested in knowing more about Insatech Pharma as your project partner feel free to contact our Pharma expert to a discussion of how we can help you manage and maintain project success.

Insatech Pharma with ISO 9001 management system certification.

Contact our expert

Lars Christiansen

+45 2085 6083