Ensure systems compliance with common regulations.
Reduce time & resources associated with computer systems validation
Tailored validation approach - either standard or customized validation documentation
Guarantee successful regulatory audits
Validation experts execute the entire validation process and produce the necessary documentation
EXTEDO is the only vendor that provides solutions covering the entire regulatory landscape. In addition, our partnership with over 35 regulatory authorities around the world helps us to ensure that we remain on the leading edge of standards development and continually provide the highest-quality solutions. This extensive expertise and inside knowledge enable us to help our customers successfully pass regulatory audits, first time.
Our computer and software validation process builds on our proven validation framework. This includes SOPs for project-specific validation plans, installation plans and protocols, test plans and protocols, performance qualification and change documents. Utilizing this framework significantly reduces the time spent completing validation. In addition, all EXTEDOpulse apps are accompanied by standard CSV documentation covering each release of the software environment. While documentation is provided in English, EXTEDO’s team is also able to offer multi-lingual support for certain regions.