Almost every Lab Informatics software vendor provides some variation of a software validation documentation starter kit that may make it seem as if their software is validated for use right out of the box. And while this documentation often addresses more than just installation and qualification of their standard install, it does not encompass all the key elements and deliverables of a validated system based on your intended use. Do you know what a vendor typically provides in their in their validation documentation? Do you know where the gaps exist between what is provided and what is needed based on current industry best practices? Are you prepared to address, fill, or defend those gaps during an audit?
In one hour, learn what is typically provided by a vendor in their validation documentation and what gaps you need to be prepared to address or defend. Understand how you can leverage vendor validation documentation to reduce your overall validation effort while ensuring your software is fully validated for your intended use.
- Learn what often comprises vendor validation documentation
- Tips for leveraging vendor documentation to ensure compliance
- Answers to Frequently Asked Questions about vendor documentation
- Understand what is required to fully validate your informatics software