Changelog - gxpSign | GxP E-Signature Platform

v1.0.1 No Validation Impact

2026-09-06

Removes the last latest image-tag fallback from the deployment compose template. The live production compose and the release workflow were corrected in v1.0.0; this template carried the same construct under a different variable name and was missed. No application code changes — the running system is functionally identical to v1.0.0.

#	Type	Description	Val. Impact	21 CFR Part 11
1	Infra	`deploy/docker-compose.prod.yml` uses `${IMAGE_TAG:?...}` instead of `${IMAGE_TAG:-latest}`, so a missing tag aborts the deployment rather than resolving to whatever shipped most recently	None	No — deployment tooling only

v1.0.0 High Validation Impact

2026-09-06

First validated release of GxPSign. This entry is the baseline for change control: it establishes the qualified state of the system rather than describing a change to it. Development history before this release predates validation and is not part of the controlled record — it remains available in the repository's git history, but no pre-1.0 version was released under change control and none should be cited as a qualified state.

Everything in scope is therefore qualified as a whole, not as a set of increments: PDF e-signature workflows with 21 CFR Part 11 aligned signature manifestations, an append-only signature audit trail, PostgreSQL row-level security for tenant isolation, OIDC/SAML single sign-on with re-authentication at signing, and the release pipeline that deploys it.

#	Type	Description	Val. Impact	21 CFR Part 11
1	Compliance	Baseline qualified state established at v1.0.0; prior versions are pre-validation and not part of the controlled record	High	Yes — establishes the validated baseline
2	Feature	PDF signature workflows: requests, field placement, sequential and parallel signers, external signer access via single-use tokens	High	Yes — e-signature
3	Feature	Signature manifestations record signer identity, timestamp and signature meaning; signing requires re-authentication under the sending organization's policy	High	Yes — §11.50, §11.200; Annex 11 §13.3
4	Feature	Append-only signature audit trail, exportable per request	High	Yes — §11.10(e)
5	Feature	Tenant isolation enforced by PostgreSQL row-level security rather than application filtering	High	Yes — §11.10(d)
6	Feature	Multi-tenant SSO (OIDC and SAML) with invitation-gated account provisioning	Medium	Yes — §11.10(d) access control
7	Infra	One build per release: production promotes the digest qualified on test and never rebuilds; the release fails unless the test environment demonstrably ran that digest	None	No — release control only
8	Infra	Production runs a pinned version tag with no `latest` published and no default in the compose image reference	None	No — release control only

System Changelog

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