Terms of use

Everything on this site is general information. It is not regulatory, legal or quality advice, and it does not replace your own quality unit, your validation work, or advice from a qualified consultant or lawyer who knows your products and processes.

Regulations and FDA guidance change, and how they apply depends on your records, your systems and your predicate rules. Check the current regulation text and guidance before you rely on anything you read here.

FDA keeps no list of certified Part 11 vendors or products. Whether a system meets Part 11 in your use is something your organisation establishes and documents itself. No page, tool result or comparison on this site certifies, approves or endorses any system, vendor or practice.

The tools are aids for thinking a question through. Their results depend on what you enter and on simplifications we make to keep them usable. Review every result yourself before it goes into a controlled document, a validation plan or a decision.

Where pages describe software vendors, they report what the vendors publish about their own products, read on the date shown on the page. Vendors change their products and documents, so confirm the details with the vendor. Product and company names belong to their owners.

The site, its content and its tools are provided as they are, without any warranty that they are complete, current, accurate or fit for a particular purpose.

To the extent the law allows, GxP Deck is not liable for any loss or damage that comes from using the site, its tools or its content, or from relying on them.

Pages link to regulation text, FDA guidance and vendor documentation so you can read the source. Those sites are run by others; we do not control them and are not responsible for what they say.

These terms may be updated. The date at the top shows the latest version, and using the site after a change means you accept the updated terms.