Contact us
Gaëtane Metz
Operational Director
ALTRAN Life Sciences
Mob: +32 (0)498 40 29 72
Xavier Duburcq
Operational Director
ALTRAN Life Sciences
Mob : + 32 (0)496 29 92 06
Qualification & Validation
From Engineering to Validation
For successful investment projects we handle the end-to-end coordination and execution of field engineering activities. We also provide commissioning and qualification till process validation following the industry’s best practices for the regulatory acceptance of your investment.
We focus on regulatory compliance for Requirement Specifications, Equipments, Facilities & Utilities Qualification, as well as Cleaning & Process Validation. Depending on your needs and internal practices, we will use the most adapted approach(es):
- V-Cycle
- GAMP 4 - Risk-based approach
- GAMP 5 - Integrated Commissioning & Qualification
- Lean approach
- ASTM E-2500-07
Our consultants are fully trained on Project Management practices, Prince 2 and/or PMI to run your Qualification and Validation projects with efficiency and rigor.
Get a personal insight into our activities
Interview with Gaëtane Metz
Validation must adapt to technology, when technology cannot adapt to validation. Thanks to the diversity of our know-how and the expertise of our consultants we carry out with efficiency and relevance your qualification activities. With combining risk and criticity analysis, we provide the validation of your systems, software, process, facilities, equipments, utilities in complete independence. It is the quality of validation that supports and legitimates technology, and not the opposite.
Brochure
Consultants Interviews
25/06/2011
LS Interview with Annelore N.
Name: Annelore N. - Position: Quality Assurance and Engineering...
11/05/2012
TEM Interview with Barbara C.
Name: Barbara - Position: Lead Consultant - Industry: Telecoms & Media
