Validation of HAVGATE as quality-system software

Business and Enterprise plans are described on the product pages as including IQ/OQ protocols, test scripts and validation summary templates. You still define intended use and you still execute the tests for the way you configured the system.

What the product pages already say

The QMS page says Business and Enterprise plans include IQ/OQ protocols, test scripts and validation summary templates for 21 CFR Part 11. The audit page says Business and Enterprise customers can request access to that package, including a validation summary, to support Part 11 and Annex 11. Both sentences are on the site. They are not identical. Until they are aligned, quote the page you are pointing at, and do not upgrade 'can request' into 'is certified'.

The data-security shared-responsibility table assigns 'Validation for intended use (IQ/OQ/PQ)' as protocols from HAVGATE and execution plus documentation from the customer. That split is the rule to keep. A vendor packet in a folder, unread, is not validation of your process.

How to think about IQ, OQ and computer software assurance

Installation qualification records that the system was installed as specified. Operational qualification challenges the functions you rely on: an approval, a signature, a refused login. Performance qualification shows the system in your process, with your people. FDA's computer software assurance approach is risk-based assurance of software used in production or the quality system. It does not delete the need to write intended use and to keep the result. The glossary pages on IQ/OQ/PQ, computer software assurance and Part 11 are the short versions.

Intended use for a typical HAVGATE workspace is audits, CAPA, document control, training and suppliers, plus the separate CRM and bookkeeping modules if you turn them on. A feature whose failure would affect a required record needs a test. A feature you do not use does not need a novel. The sample audit report is a fictional illustration of report structure, not a validation protocol.