Tailored QMS framework for innovative consumable reagent kit to comply with cell and gene therapy companies

Purpose and goal:

In this project, we aim to set up a customized quality management system (QMS) framework to ensure our quality and consistently deliver products that meet customers’ expectations while complying with relevant quality regulations. This project will fall into a perfect timeline as we are developing our second product GeneAbacus HT which is aimed at biotech and pharma companies.

Expected results and effects:

This strategic development in collaboration with PlantVision will be key to achieve our vision to become the gold standard for gene editing analysis by meeting industry standards for cell and gene therapy companies. The aim is to implement a QMS framework that follows and will support ISO 13485 which are relevant for the targeted market segment

Approach and implementation: QMS roadmap and strategy: 1. Needs analysis - a needs analysis is performed in form of a workshop.

2. Scope identification - the delivery manager of the project compiles the results of the workshop and makes an assessment of the most favorable strategy. 3. Project definition -a list of prioritized Standard operating procedures (SOP) are presented. 4. Issue review and approve documents - The SOPs are written.

5. Follow up - are done with company representatives. 6. Training - a specific training session are held for the whole company. 7. Hand over