Sage X3 Validation in a GxP Environment

ADN is one of the most recognized French consultancies for computerized system validation (CSV) applied to Sage X3 in GxP and MDR environments. We support your projects from A to Z: new implementation, version upgrade (V6, V11, V12) or revalidation after a major change such as an EDI flow or a Quality module.

Our approach to Sage X3 validation
 

Our consultants master the critical GxP and MDR processes of Sage X3 (batch management, traceability, quality control, data integrity) and produce deliverables scaled to the real risk. We maintain the validated state during future changes to the system.
 

Critical GxP Sage X3 modules
 

• Production management and manufacturing orders

• Quality control via the dedicated Quality module

• Batch management and upstream-downstream traceability

• Data integrity and audit trail
   

Our validation deliverables
 

• Specifications and functional risk analysis

• Validation Plan

• IQ/OQ/PQ protocols and scripts

• Requirements-tests-results traceability matrix

• Validation report and associated procedures

• Maintenance of the validated state during changes
   

Regulatory compliance
 

Validation covers the audit trail and electronic signature requirements of 21 CFR Part 11 and GMP Annex 11. We work in France and internationally, on a time-and-materials, fixed-price or team-augmentation basis.
 

Frequently asked questions
 

Do you need to revalidate Sage X3 after a version upgrade?
 

A major upgrade (for example to V12) requires an impact analysis to determine the affected GxP functions. Revalidation is then targeted at those functions rather than the whole system.
 

Does a Quality module need to be validated separately?
 

A Quality module carries critical quality processes (control plans, release) and is an integral part of the GxP validation scope of Sage X3. The function codes generally contain the letter X or Y.
 

How long does a Sage X3 validation take?
 

The duration depends on the GxP functional scope and the risk level. A preliminary assessment makes it possible to estimate the effort before scoping the project.

​

What is CSA and does it change Sage X3 validation?

 

Computer Software Assurance is the FDA's 2022 approach that refocuses testing effort on patient risk and product quality while reducing low-value documentation. It applies fully to Sage X3 projects. ​

​​

Is it possible to relieve my users of tasks seen as time-consuming?​

 

Yes, we offer solutions that let AI agents run tests in place of your key users, and help overcome writer's block when drafting specifications.