Validation of Software Used in QMS

[ISO 13485:2016 Clause Clause 4.1.6]

QMS Software Validation

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) specifically for the medical device industry. Any software used in the implementation of the quality management system needs to be validated to ensure that the software performs as intended and enables the manufacturer to produce quality products conforming to the applicable regulatory & customer requirements.

Overall, the QMS software validation process assures eQMS software performance is accurate and consistent. This ensures the integrity and quality of documentation. Organisations may use the below tool for recording internal audit findings.

INTERNAL AUDIT TOOL

1. IMPORTANT INFORMATION - Step 1 of 6

Certainly, we will be happy to provide you with a detailed service proposal for European Authorized Representative and allied services. To do so, please provide us with the following information:

Manufacturer Name *

Address *

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