AUVESY’s Commissioning and Qualification Services (IQ/OQ Services):
A 3 step Process
versiondog’s Installation and Operational Quality Services quickly validate versiondog’s installation and operation against the organizations industry requirements for FDA, GxP, or other compliance needs. Our Commissioning and Qualification Services:
- Provide documented evidence that validates versiondog will meet the organizations compliance requirements which can limit the chance of compliance violations.
- Speed up deployment which saves time, manpower and reduces costs.
- Utilize AUVESY’s expertise in versiondog and regulated environments to speed of the compliance testing requirements.
IQ/OQ is a 3 Step Process
Step 1 (Bundle 1)
- Create the User Requirement Specification (URS) document – Assist the customer to outlining the requirements needed by versiondog.
- Create the Functional Risk Assessment (FRA) document – Take the requirements outlined in the URS and determine the criticality of the requirement against the compliance standards along with the probability and severity.
Step 2 (Bundle 2)
Take the URS and FRA documents and create the Installation Qualification and Operational Qualification (IQ/OQ) documents.
- Installation Qualification (IQ) document – This document will outline the detailed test objectives and eventually provide the evidence from the tests to certify that the versiondog installation meets the requirements of the URS and FRA documents.
- Operational Qualification (OQ) document – This document will outline the detailed test objectives and eventually provide the evidence from the tests to certify that the operation of versiondog meets the requirements of the URS and FRA documents.
Step 3 (Bundle 3)
This is the certification process in which the tests are carried out following the IQ/OQ documents and then the results are documented as evidence of compliance.
To learn more how AUVESY’s IQ/OQ Services can be used at your company, contact our knowledgeable sales team today!