Source-connected ANDA operating system

Regulatory control tower for every ANDA decision.

Coordinate master data, agency sources, readiness scoring, controlled evidence, reviewer signoff, technical preflight, deficiency risk and board-level decisions from one auditable workspace.

Active Program

Decision-support workspace for qualified teams. Final submissions require current agency guidance review and authorized CMC, QA, BE, regulatory and legal signoff.

Program Health Cockpit

Connecting

Program IDNot created

Stage Gate--

Readiness Band--

Next ActionCreate or load a programThe workspace will prioritize the next controlled step.

Deficiency RiskNot assessedRun risk simulation after evidence is available.

FDA Source FreshnessNot importedImport and refresh source snapshots.

Packet StateNot builtBuild a controlled packet when core evidence is ready.

Today's Queue

Start with master dataCreate the controlled program record.

Stage-Gate Snapshot

Program setupStage gates appear after generation.

Connected program path

One program record, six connected workflows.

Move from product selection to lifecycle control without losing the decision, evidence, owner, or review state between specialist modules. Status is derived from the active program evidence spine.

OverviewReadiness, next action and controlled operating state.

Program Master Data

Product Name

Active Ingredient

Strength

Dosage Form

Route

RLD / Reference

Market

PSG Status

Target Filing Date

Q1/Q2 Strategy

Manufacturing Site

Target Margin %

ANDA Readiness

Create a program to generate multi-dimensional readiness scoring.

Enterprise Evidence Operations

Run enterprise capabilities to review evidence control, source intelligence, validation, authoring, governance and portfolio outputs.

Regulatory Stage Gates

Stage gates convert the evidence spine into controlled development decisions.

Controlled Evidence Spine

Evidence Type

Status

Owner

Confidence

Source Type

Jurisdiction

Source URL

Document / Source ID

Evidence Summary

Module Result JSON

Reviewer Workflow

Role

Status

Reviewer

Comments

Evidence Review Center Phase 2

Review immutable module-result versions. Assign an accountable program-review role, compare evidence versions, and record an authenticated evidence decision. Role assignments and evidence decisions are separate; the backend identity is authoritative for approvals.

Evidence record

Compare from

Compare to

Assigned program role

Program-role reviewer

Evidence decision

Review comments and decision basis

The immutable evidence ledger appears here.

Select two versions of the same evidence record to inspect field-level changes.

Working Document Packet

Build a working packet from the current program record. Use the Phase 2 accepted-evidence packet for a controlled review draft.

Document Versions

Packet versions appear after each controlled packet build.

Version Diff

Build two packet versions to compare document movement, score changes and status changes.

Accepted-Evidence Decision Packet Phase 2

This packet includes only the current version of evidence that has an authenticated approved review. Stale accepted versions and unaccepted source ledgers become explicit blockers.

FDA Source Import

Import official FDA/openFDA source references into the evidence spine with provenance.

Source Watch

Refresh source snapshots and detect source-level movement before packet lock.

Official-Source Review Ledger Phase 2

Imported and refreshed official sources will be normalized with retrieval status, content hash, change signal, and human-review status.

Evidence Graph

The graph links program dimensions, evidence, reviewers, FDA sources, documents and risks.

Module 3 Evidence Matrix

Map CMC sections to controlled evidence, owners, status, blockers and next actions.

eCTD Sequence Builder

Create a planning sequence, leaf manifest, lifecycle operations and validation preflight.

Controlled Correspondence

Draft specific FDA question packages from the latest risk, evidence and source state.

ANDA Deficiency Risk

Generate deficiency risk after creating or loading a program.

Agency Question Simulator

Generate agency questions from the latest risk and evidence state.

Audit Trail

Audit events will appear after program creation, evidence updates, reviews and packet generation.

Signoff Queue

Track required signoffs, evidence hash, lock blockers and controlled unlocks.

Portfolio Control Tower

Compare programs by readiness, risk, source freshness, gate completion and workflow state.

Exportable Board Pack

Board packs package the controlled program state for leadership review and decision logging.

Enterprise Control Plane Phase 3

This workspace reports application controls and evidence state. It does not claim that an external identity provider, connector, signature provider, monitoring service, backup system, or disaster-recovery environment is qualified.

Load the tenant-scoped control plane to inspect effective readiness and blocking conditions.

Organization, SSO & Scoped RBAC

Organization display name

Allowed email domains

SSO protocol metadata

Provisioning metadata

Issuer

Metadata URL

Verification evidence references

Binding ID

Directory group

Enterprise roles

Workspace scope

Program scope

Binding state

Browser-supplied roles never grant authoritative access; signed server identity remains authoritative.

Validated-System Integration Registry

Register DMS, LIMS, QMS, and RIM connection metadata and managed credential references only. Provider secrets and external payload bytes are rejected or remain outside this application.

Integration ID

System type

Display name

HTTPS endpoint origin

Registry direction

Authentication mode

Managed credential reference

Verification state

Verification evidence references

Data classifications

Registered integration ID

Handoff direction

Object type

Payload SHA-256

External reference

Evidence IDs

No integration metadata loaded.

Qualification Gate, Operations Evidence & Audit Integrity

Signature policy

Provider name

Provider reference

Intended scope

Qualification evidence references

Saving this policy never enables an electronic-signature endpoint. Current Program OS approvals remain hash-bound attestations until a formally qualified provider and deployment-specific controls are activated.

Operations evidence type

Outcome

Performed at

Evidence references

Summary

Non-sensitive metrics JSON

Operations evidence is append-only and freshness is evaluated by the backend. Audit verification recomputes the tenant-scoped hash chain.

Advanced Program JSON

Open advanced payload

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