Transparent and seamless
Of course, every INTEGA project also includes careful documentation of the scope of services provided up to the commissioning of your system. We also have extensive experience in the area of production according to CE (marking of the EU) or ATEX (directives of the EU, explosion protection) specifications with projects from renowned manufacturers.
The INTEGA documentation in a clear design gives you the certainty that your systems, components and tools have been manufactured in accordance with the valid standards. Take advantage of our INTEGAdocuPRO system for system documentation. All relevant protocols and documents are clearly arranged for you here. We are also happy to work according to the specifications of your own documentation system.
Safety is the number one priority for pharmaceutical and GMP equipment and is rigorously tested. The highest quality standards and requirements apply, which we at INTEGA are able to meet to your purest satisfaction thanks to state-of-the-art technology, fine-precision working methods and constant checks.
In terms of quality assurance, the entire production process up to the final assembly is subject to the strictest documentation and testing obligations. This includes for instance:
- Endoscopy/video endoscopy
- Roughness measurements
- FDA/GMP-compliant plant documentation
- FDA/GMP-compliant weld seam documentation
For the seamless documentation of your pharmaceutical project, we are happy to work according to the specifications of your own documentation system. Or you can exploit the advantages of our in-house developed, pharma compliant system INTEGAdocuPRO.
prescribed DIN standards and regulations
- Documentation that fully complies with legal requirements and CE specifications
- Machinery Directive 2006/42/EC
- Pressure equipment directive 2014-68-EU
- Low Voltage Directive 2014-35-EU
- Explosion Protection Directive 2014-34-EU
- DIN Technical Report 146
- Standards for risk analyses
- Risk assessment according to DIN EN ISO 12100:2010
- Standards for plant descriptions/operating instructions
- Plant documentation including operating instructions according to the specifications of the Machinery Directive 2006/42/EC and DIN Technical Report 146, implementation of DIN EN 82079-1:2010
- Necessary certificates
- CE Declaration of Conformity or Manufacturer Declaration
Documentation received once again
You have to show the documentation for an INTEGA system with commissioning within the last five years? Your backup copy is no longer available? No problem - feel free to contact us. We can certainly help you via our reliable project database.