Validation and qualification in accordance with GAMP/FDA

We support and look after our customers from the pharmaceutical sector in all three cycles of a process validation in accordance with FDA:

  • Process design during development or engineering
  • Process qualification from engineering to operation of the plant
  • Continued process perification during production

Our services are:

  • Documentation of User Requirements
  • Change Control
  • Design Qualification (DQ)
  • Factory Acceptance Test (FAT)
  • Site Acceptance Test (SAT)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Validation (prospective, retrospective)
  • Qualification
  • 21CFR11
  • Batch recipes development
  • SFC
  • CFC
  • Visualisations
  • Integration of Package Units over all common interfaces
  • Documentation (User Requirements, Specifications, Design, Manuals)

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Helix GmbH Frankfurt | Hanauer Landstraße 52 | 60314 Frankfurt am Main
Tel: 069-47893530 | Fax: 069-47893544 | Mail: helix@helix-gmbh.net

Helix GmbH Oberhausen | Otto-Roelen-Str.1 | 46147 Oberhausen
Tel: 0208 - 302 00 61 | Fax: 0208 - 302 05 95 | Mail: oberhausen@helix-gmbh.net

Helix China (Shenzhen) - Main Office 深圳市福田区益田路3013号南方国际广场B座2楼1501. 517048
1501, Block B, Southern International Plaza, No. 3013 Yitian Road, Futian District
Shenzhen, China. 517048
Tel: +8675583017107 | Fax: +8675583017094 | Mail: shenzhen@helix-gmbh.net

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