Quality picked the tool; you inherit the risk. Here’s the short version of the security review, the validation burden, and what lands on your backlog. Spoiler: not much.
Quality software fails IT review for predictable reasons: electronic signatures bolted on rather than built in, no usable audit trail, authentication that cannot join your identity provider, and a change process that turns every workflow tweak into a revalidation project. Those are architecture decisions, and they are made long before a demo.
21 CFR Part 11 requires that signatures be attributable and bound to the record they sign, that audit trails be secure, computer-generated, and time-stamped, and that records remain retrievable throughout their retention period. In Kintavo the audit trail is append-only by construction — there is no administrative path to edit or delete an entry, because the data model does not provide one. That is a meaningfully different claim from a system that logs changes to a table someone with database access could alter.
IQ/OQ/PQ documentation is delivered with the platform and executed against your configured instance, not handed over as a generic template for your team to adapt. Test scripts trace to requirements; evidence is captured as the scripts execute. For teams moving toward Computer Software Assurance, the risk-based argument is easier to make when the vendor's own qualification evidence is available rather than reconstructed.
The reason quality teams stop improving their processes is that every change costs an IT ticket and a revalidation cycle. Configuration in Kintavo — workflow routing, escalation rules, form fields, approval logic — is separated from the validated platform core, so a quality manager can change a routing rule without triggering a code deployment. Configuration changes are themselves versioned, approved, and audit-trailed, which is what makes the separation defensible to an inspector rather than merely convenient.
SSO and SAML against your identity provider, role-based access down to the record, encryption in transit and at rest, SOC 2 Type II report available under NDA, and a BAA for covered entities. Penetration testing is performed annually by an independent third party, and the summary is available to prospective customers under the same NDA as the SOC 2 report.
Ask for all of it before the demo if it helps — the security package goes out within one business day, and nobody makes you sit through a call to get it.