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Qualification and documentation

The QUALIFICATION of Telstar units enables verification and confirmation during the different project stages (design (DQ), installation (IQ), operational (OQ) and are in accordance with design and manufacturing practices of ISO 9001:2000 international quality standard), the good manufacturing practices (cGMP, GAMP, 21 CFR Part 210-211 and part 11) and the current applicable standards (CE Marking or ASME).

The equipment qualification plan is represented in figure 1., ‘Qualification Life Cycle', which clearly reflects how quality control will be managed and carried out throughout the entire project. Everything is drawn up according to Customer Requirements (URS) and design specifications, which are generated at commencement of the project by the user in isolation or with Telstar's collaboration.

 

 

The machine acceptance at the Telstar facility, FAT (Factory Acceptance Test), is carried out in the presence of the customer following a protocol produced to guaranteeing correct installation and operation of the equipment.

After start up of the equipment, acceptance is confirmed with the SAT (Site Acceptance Test) protocol. The objective is to verify and confirm optimum operation of the unit in its final position.

The entire qualification process is carefully drawn up and documented to provide a complete report, which is easy to navigate and understand.

Software validation is carried out as an optional activity.

After the installation qualification, complete TECHNICAL DOCUMENTATION is generated, comprised of: (documentation life cycle)

  • Installation manual
  • User manual
  • Maintenance manual
  • List of components/technical feature cards
  • As-built diagrams and sketches
  • EC (if applicable)