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Abtract of projects

As a consultant, I generally don't talk about clients. Keywords: Trust and commitment.

But the following selection of  projects that we have successfully worked on in the course of our professional activity.

Project 01

Topic: Selection of suitable packaging systems for the registration (regStab) of pharmaceutical products.

Objective: Creation of a global process involving development locations with different cultural backgrounds.

Realization: Integration of an IT tool, ensuring data integrity, planning tool for storage and retrieval times for different climatic conditions and capacity planning climate cabinets.

Project 02

Topic: Order planning of clinical test samples (IMP), approx. 1'200 orders p.a.

Objective: Creation of a global planning tool for over  2 locations (USA and Switzerland)

Realization: Development and integration of an IT tool with an integrated workflow system for planning packaging orders for clinical test samples and integration of worldwide shipping to test centers.

Project 03

Topic: Two existing packaging system leakage

Objective:  As fast as possible elimate the issues.

Realization: Elimination of the cause using the ATS method. Set up new manufacturing process development (CtM, CtQ, CtP), statistical evidence, adjust QC plan, documentation according to ISO 13485 Chapter 7.

Project 04

Topic: Development of a modular packaging system for medical products (Sterile Barrier System)

Objective: Shorten development times, and reduce costs for performance testing and Stability testing (ISO 11607-1:2019).

Realization: Analysis of the worldwide distribution conditions, definition of the worst-case process, development of the modules, construction of prototypes, involvement of the stakeholders for the decision, definition of the worst-case products, testing, integration of the notified body (evidence by document), official change notification, consistent application of ISO 13485 and ISO 14971

Project 05

Topic: A non ISO 13485 manufacturer outside of the EU creates a procedure & system and packs accord. to MDR Article 22.

Objective: Ensuring compliance with the MDR for market launch in the EU.

Realization: The customer has a QMS according to ISO 9001 - but not according to ISO 13485. Implement extensive regulatory clarifications and a supply chain concept. Establish a quasi-adapted "design control process" and create proof documents of product integrity. (Evidence-by-Document).

Project 06

Topic: Ensure compliance to ISO 11607.

Objective: Within 30 working days cratioon 20 docuements, e.g. SOPs, WIs, and templates.

Realization: Early stakeholder involvement, application of SIPOC and RACI. Presentation of a holistic concept, get the buy in and create the documents at the same time. the review of the documents was much faster.

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