Policy documents : VMP, Commissioning plan and procedure, Risk assessment Involvement in URS and specifications briefs Regulatory conceptual design review Traceability matrix and test plans Management of FAT/SAT commisioning steps Drafting and conducting DQ/IQ/OQ/PQ tests Process Validation, Cleaning and Analytical Methods Deviations and non-conformities management / Evaluation of modification requests  Maintenance of the qualified condition Audit and Training

Qualification / validation

Ekium works hand in hand with you to anticipate and handle the Commissioning, Qualification and Validation phases of your facilities and production equipment.

Tailor-made assistance

We believe in a highly specialised sectoral approach (medicine, medical and hospital devices, etc.) by providing support for your strategic choices right up until the final tests. Our experts make use of both classical and optimised methodologies (Capitalisation of FAT/SAT).

  • Policy documents : VMP, Commissioning plan and procedure, Risk assessment
  • Involvement in URS and specifications briefs
  • Regulatory conceptual design review
  • Traceability matrix and test plans
  • Management of FAT/SAT commisioning steps
  • Drafting and conducting DQ/IQ/OQ/PQ tests
  • Process Validation, Cleaning and Analytical Methods
  • Deviations and non-conformities management / Evaluation of modification requests 
  • Maintenance of the qualified condition
  • Audit and Training

 

 

Discover our projects per markets

Nos engagements qualité

We believe that continuous improvement is a top priority in terms of guaranteeing our clients' safety requirements (quality, safety, radiation protection, confidentiality.

certification ISO 9001 certification ISO 9001

ISO 9001 - Qualité

certification OHSAS 18001 certification OHSAS 18001

OHSAS 18001 - Santé Sécurité au Travail

MASE / UIC MASE / UIC

Mase

CEFRI CEFRI

CEFRI

Qualifoudre Qualifoudre

Qualifoudre

Ekium est qualifié pour intervenir en centrale nucléaire Ekium est qualifié pour intervenir en centrale nucléaire

EDF UTO

Ism ATEX Ism ATEX

Ism ATEX

Quali-SIL Quali-SIL

Quali-SIL