REIGN · EVIDENCE PACKS
Submission-ready evidence. On demand.
Policy by default. Evidence by design. Enforced at runtime.
Reign Evidence Packs are the regulatory-packaging layer of the Reign platform — submission-ready artifacts assembled from continuous evidence capture, mapped to the framework citations regulators expect, and exportable in the formats they ingest. IND, NDA, BLA, PCCP, 510(k), DORA reports, AIGF assurance, and more.
Deployment
Same governance layer across every tier.
Audits are passed on packaged evidence — not on logs
Regulated industries do not pass an audit on the strength of their logs. They pass on the strength of evidence that is mapped, signed, and packaged in the format the regulator can read. Today, that packaging is a months-long manual exercise: pull data from logs, reconcile with audit trails, hand-build mapping tables to the framework citations, and assemble a submission document in the format (eCTD, FDA briefing book, DORA report) the regulator expects. Compressed timelines — like the new CMS-FDA RAPID coverage pathway — make that manual exercise impossible.
- Logs are not evidence. Evidence is logs that have been mapped, signed, and packaged.
- Each regulator wants a different format: eCTD modules for FDA, DORA reporting templates for EU financial services, ISO 42001 audit packages for general AI risk.
- Mapping evidence to specific framework citations (21 CFR Part 11 §11.10, EU AI Act Article 12, AIGF risk #14) is repetitive, error-prone work.
- Cryptographic integrity is required end-to-end — from the original AI inference event through every transformation to the regulator hand-off.
- Compressed regulatory timelines (RAPID, FDA PCCP modifications, DORA incident reporting) mean evidence must be available continuously, not assembled retrospectively.
Reign Evidence Packs provide
Continuous assembly
Pulls from the Evidence Engine, Data Vault, and Model Lifecycle automatically — no manual reconciliation.
Framework-mapped
Every evidence element is annotated with the specific regulatory citation it satisfies (21 CFR Part 11 §11.10, EU AI Act Art. 12, AIGF v2.0 risks, NIST AI RMF functions, ISO 42001 clauses).
Multi-format export
IND, NDA, BLA, 510(k), PCCP, DORA reporting templates, AIGF assurance reports, ISO 42001 audit packages — exportable in the format the regulator ingests.
Cryptographic integrity
Hash-chained evidence preserved across handoffs to internal QA, external auditors, and regulators.
Custom packets
Customer-defined templates for joint submissions, audit responses, and partner-facing assurance.
On-demand generation
Available on demand — submission-grade evidence is generated when needed, not assembled six weeks before filing.
The regulator-facing output of the Reign platform
Evidence Packs is the regulator-facing output of the Reign platform. It consumes the continuous evidence stream from the Evidence Engine, the data lineage from Data Vault, the model-version metadata from Model Lifecycle, the policy decisions from the AI Gateway, and the tool-call graph from the Agentic Hub. It assembles all six native components’ outputs into a single, signed, regulator-ready submission artifact. Every Evidence Pack is reproducible: the same query against the same evidence corpus produces an identical, hash-verifiable artifact.
Mapped to the frameworks regulators expect
21 CFR Part 11
Electronic records and signatures (life sciences submissions).
FDA IND / NDA / BLA / 510(k)
Submission templates and required artifacts.
FDA PCCP
Predetermined Change Control Plan submission documents.
EU AI Act Art. 11
Technical documentation for high-risk AI systems.
EU AI Act Art. 12
Record-keeping for high-risk AI systems.
ALCOA+
Data integrity attributes packaged into the submission artifact.
DORA Art. 28 + reporting templates
Third-party ICT incident and audit reports.
FINOS AIGF v2.0
Assurance reports for the 25 AIGF risk categories, including the six new agentic risks.
ISO 42001
AI management system audit packages.
NIST AI RMF
Function-aligned reporting (Govern, Map, Measure, Manage).
Frequently Asked Questions
A submission-grade artifact containing the evidence elements required by the chosen framework — for example, an FDA PCCP submission packet contains model version history, change-control packets, validation results, performance monitoring evidence, and the cryptographic hash chain linking every element to the original AI inference events. The exact contents are determined by the target framework and the customer’s submission scope.
The first packet templates available through the design partner program cover FDA 21 CFR Part 11, FDA PCCP, EU AI Act Art. 11 and Art. 12, ISO 42001, and FINOS AIGF v2.0 assurance. Additional templates for IND/NDA/BLA, DORA reporting, NIST AI RMF, and 510(k) are sequenced into Q4 2026 GA.
Yes. Customers and design partners author their own packet templates against the underlying evidence corpus. Joint-submission templates for partner-led filings (CRO, sponsor, system integrator) are first-class supported.
Yes. Every Evidence Pack is hash-chained from the original AI inference event through every transformation, with cryptographic signing at the artifact boundary. The integrity is verifiable independently.
On-demand. The evidence corpus is continuous, so pack assembly is a query against existing evidence, not a retrospective reconstruction. Most submission packets generate in minutes to a few hours, depending on scope.
Reign Evidence Packs are available today through the Reign Design Partner Program, with broader release scheduled for Q4 2026. Design partners shape the packet templates, the framework mappings, and the export formats that ship at GA.
Reign components