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However this freedom does not affect the basic directives; which mandates, the documented need for the suite of documents to start at the VP then the URS and on through the VRA, DQ, IQ, OQ to the PQ.

These regulatory requirements exists and must be complied with.

The implication is that government policies aiming at assisting small manufacturers to modernize should not overlook the strong ‘pull’ effect of the markets targeted by these manufacturers.

ABSTRACT: Computer numerical control (CNC) technology has received high level of investment around the world.

Considering machine tool for machining operations, almost one third of those installed in Brazilian industrial companies is composed of CNC machines.

About 46% of them are less than ten years old and belong to a generation of machine tools that should have a higher density of automation, incorporating features and advanced production techniques that suppose efficient management.

The term machinery relates to any metal moving or removing equipment which is largely mechanical in operation, but may have software management or recording facilities. Many other countries also have an agency to manage this requirement and those that don’t usually rely on the World Health Organization (WHO).

case studies for validating cnc machines-59case studies for validating cnc machines-11case studies for validating cnc machines-14

Machinery validation is a mandatory requirement when ever a machine is used in a way that can affect the quality, safety, efficacy of a controlled product or jeopardize the integrity of any predicated data, relating to that product.

However, there is a low rate of utilisation of available resources, such as tool presetting, in-process measurement systems and automatic load and unload to reduce idle time.

Additionally, there is a reduced use of techniques to achieve higher maximum cutting speeds and longer tool life.

A KCV1000 and a VP600, 5-axis machines from OKK USA Corp., are essential to machine many of their parts.

Our company was looking for a back-up system for all the programs we use in our machines, CNC, Grinders, Gear Hobbers, Gear Cutters etc.

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