NewLogo.png

COMPUTERIZED SYSTEM VALIDATION
SOFTWARE VALIDATION

ISO 13485: 2016  - ISO / TR 80002-2, IEC 62304, 21 CFR Part 11, GAMP 5, CSA

GxP Systems

V-Cycle - Agile - DevOps

Give value to your validation!

Optimize your validation times in complete safety

Gain in the quality of deliverables

Accelerate the value brought to your business teams

Rely on an experienced consultant to support you in your risk-based validation strategy, and guarantee the success of your FDA, EMA, ISO 13485 or 62304 projects.

Rely on an experienced consultant combining business knowledge and standards or regulations, to write the deliverables strictly necessary for the control of patient risks or critical data. 

Intensify your ability to validate more releases with the same resources, thanks to our regulatory or normative approach to Agility in a DevOps context.

___________________________

___________________________

___________________________

ADVICE

We support our customers in their FDA or CE certification projects.

___________________________

Do you have a new software product to register on the market? A new computerized system to be brought into compliance with FDA or 13485?

For 30 years, we have acquired both the experience, the hindsight and the technical expertise to help you meet the challenges related to this technological wave.

  • Are you looking for an expert to guide you through software compliance? 

  • Are you looking for an expert to advise you on compliance issues related to new technologies?

  • Are you looking for an experienced and independent consultant to manage your validation projects?

  • Are you looking for a LIMS project manager ?

SOFTWARE INTEGRATION

We support our customers in the dematerialization of their validation.

___________________________

Do you want to gain speed and traceability for your validations? Is electronic signature becoming essential in your telecommuting context?

For 30 years, we have acquired the experience of dematerialization on a large number of projects, and software of the ALM or Agile type.

Are you looking for an ALM GxP expert ? an Xray Expert ?

Are you looking for an Agile or DevOps expert, with 62304 or GXP experience?

Looking for advice on how to conduct a paperless validation transformation?

TRAINING

We offer our clients validation-oriented training in a context  pharmaceutical or medical device.

___________________________

Software validation is a profession in its own right, which has evolved very quickly under the spotlight of recent and future digital transformations.

If the classic validation based on Cycle V remains the most widespread, the rise of Agility is undeniable and draws a set of training needs.

Are you looking for a traditional validation training, Cycle in V, type Gamp 5?

Are you looking for an Agile Validation training?

image_2021-12-07_000049.png

THEY TRUST US

Logo_Pierre_Fabre.png
Servier.png
UROMEMS.png
Logo-FineHeart-Def.png
Sanofi.svg.png
Pixium.png
image_2021-12-07_000049.png

A SPECIFIC NEED OR PROBLEM?

WE STUDY YOUR PROJECT AND WE BRING YOU OUR FIRST REFLECTIONS