We created remote support to help users with a functioning system.
GAMP: Good automated manufacturing practice
MicroTechniX has developed working procedures that are adopted from the Good Laboratory Practice (GLP) guidelines. Good Automated Manufacturing Practice or GAMP arose from the Good Manufacturing Practice (GMP) legislation and describes a structured and project-based approach for validation of automisation systems. Automatisation systems for the pharmaceutical industry as well as laboratories in any industry must comply with strict requirements and laws: United states: FDA Code of Federal Regulations - Europe: Eudralex
MicroTechniX adheres strictly to these procedures to ensure undisputable correct results for every automated test.
MicroTechniX offers a tailored development from project definition to the day to day performance on the floor including validation throughout the process. Validation ensure that every step of the process does exactly what it’s supposed to do with a guarantee of reliability. Validation renders reliable processes and results in qualitative products. Good documentation is key.
As the FDA defines it: “Validation is establishing documented evidence that a system will do what it claims to do.” That’s what we put into practice everyday.
CMSE: Certified machinery safety expert
Certified Machinery Safety Expert is a globally recognised qualification enabling a 360° approach to machinery safety. A collaboration between two international leaders in their respective fields, Pilz and TUV NORD, Certified Machinery Safety Expert training is the foremost machinery safety training of its kind in the market. MicroTechniX engineers are all trained at recognised CMSE training centres.
This standard provides guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer requirements, and that quality is consistently improved. ISO 9001 is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement.
Starting from our different solutions we adapt the components tailored to your specific needs. The components we select are from certified manufacturers, developers and distributors. The high standard we put for ourself we also demand from our suppliers. This is the only way to know exactly how each component will impact the other. Every component has a specific task. By working together in a concerted action the MTX system generates the desired result.