Validation and qualification

A control and requirements

Both arms of the neyret group share the same Quality organisation system.  This is split into two parts :

  • control and oversight of the design, manufacture and checking processes,
  • responding to the requirements of the pharmaceutical, medical or automotive sector.

 

Within our companies, the Quality Department will stay with you from the design phase right up to product approval.  Our teams strive to meet all of the standards specified by our clients and their contracts.  

 

Full control over every line

Our fully qualified teams run compliance checks according to the applicable standards, and conduct validation checks on your equipment.  They run these against the current regulations, your own specifications and the sector in which the machine will be used. Detailed check reports are provided to the client, in addition to fully harmonised documents for the United States, Europe and Asian markets. In order to meet the needs and requirements of the pharmaceutical and medical sectors, our machines are designed to be used in cleanrooms (from class 100 to 100,000), and to be used in line with the GMP and FDA directives.  We validate them in-house, in our own ISO 8 cleanroom. The documents provided are approved and ready to be used for the next step of the qualification process.  The basic machine – both hardware and software – is pre-approved according to GAMP 5 and is 21 CFR-compatible (part 11).

In this way, we run the following checks and tests :

  • FAT (Factory Acceptance Testing): Qualification tests, conducted on our site prior to delivery,
  • SAT (Site Acceptance Testing): QI and QQ qualification tests, conducted after installation.

 

Our teams strive to meet all of the standards specified by our clients and their contracts.


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Machines à haute cadence indexée

The Neyret Group relies on our years of experience, our expertise and our talent for innovation to design and develop our personalised assembly solutions.  Machine designs, checks and vision tests are conducted according to a careful, multi-step process.

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