AUVESY’s Installation and Operational Quality Services quickly validate versiondog’s installation and operation against the organization’s industry requirements for FDA, GxP, or other compliance needs.
Our IQ/OQ 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 expertise in version control for regulated environments in order to speed up compliance testing requirements.
Create the User Requirement Specification (URS) document and Functional Risk Assessment (FRA) document.
- User Requirement Specification (URS) document – AUVESY will assist the customer with outlining the requirements needed by versiondog.
- 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.
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 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 evidence from the tests to certify that the operation of versiondog meets the requirements of the URS and FRA documents.
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.