WMS Validation in a GxP Environment

Compliant with GAMP 5 Second Edition

21 CFR Part 11
GMP Annex 11

The WMS is a critical system for controlling GxP logistics flows: inventory management, batch traceability, movements of raw materials and finished products, stock release. ADN supports the computerized system validation (CSV) of your WMS, from regulatory impact analysis through to maintaining the validated state.

Our approach to WMS validation
 

We target specifications on the logistics processes with a quality impact, where an error can compromise the traceability or compliance of a batch. The validation effort follows the risk-based approach of GAMP 5.
 

Critical GxP WMS processes
 

• Receiving and inbound control

• Storage and location management

• Picking and order preparation

• Shipping and traceability for batch recall

• Quality status management (quarantine, released, blocked)
   

Our validation deliverables
 

• Regulatory impact analysis and GAMP 5 categorization

• Specifications targeting critical GxP processes

• Functional risk analysis

• IQ/OQ/PQ protocols and scripts

• 21 CFR Part 11 compliance testing: audit trail, access control, electronic signatures

• Traceability matrix and validation report
   

WMS we master
 

Our consultants work on the market's leading WMS: SAP WM / EWM, Reflex WMS, Generix and Manhattan, in pharmaceutical, medical device and cosmetics contexts.
 

Frequently asked questions
 

Which WMS processes must be validated in GxP?
 

The processes affecting batch traceability and quality status: receiving, storage, picking, shipping and status management (quarantine, released, blocked).
 

Is WMS validation linked to ERP validation?
 

Often yes: the WMS exchanges data with the ERP. The interfaces between the two systems are then part of the validation scope.
 

How do you handle traceability for a batch recall in a WMS?
 

The tests verify the system's ability to retrieve all movements and destinations of a batch, an essential condition for an effective recall.

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What is CSA and does it change WMS 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 WMS projects. ​

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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.