Classify the document
Identify file type, review pathway, sensitivity status, and expected output package before analysis begins.
Coming soon - private beta access list now open
Coming soon
Traceable regulatory readiness packages, preparing for private beta.
RegAudit RWE is a local-first product environment for organizing source references, document findings, redline recommendations, clean drafts, and qualified-review handoffs. Join the access list for product updates while regulated document work stays inside authorized private workspaces.
Local-first - private - regulatory ready
RegAudit RWE
Transform regulatory complexity into clear, auditable evidence with source-linked findings, controlled review gates, and reviewer-ready outputs.
Evidence traceable
Source linked
Privacy by design
Built for review
No FDA review, approval, clearance, acceptance, compliance certainty, or regulatory determination.
19SourcesIn library
22Monitored targetsActively tracked
QAReviewer gateRequired before use
LocalProcessingPrivate by default
FDA21 CFR, RWD/RWE guidance, final delivery controls
GAMP 5Listed as optional licensed reference, not bundled in v1
ICHClinical evidence and study reporting context
EUPrivacy and device readiness context
Authorized workspace preview
Document intake lives inside the private workspace
DOCX / PDF / XLSX / CSV / TXT
Review route, source map, findings, redlines
Review route, source map, findings, redlines
W
SOP-ERS-2024-001_Electronic_Records.docx
Example controlled document preview
Locked
Standard Operating Procedure (SOP)
v
Reviewer packet first
v
Private beta access required
Review -> Findings -> Redlines -> Corrected Document
Product workflow
Designed to organize the review package, not replace the reviewer.
The public page explains the product. The private workspace performs controlled document intake, rule mapping, findings, redlines, and reviewer handoff.
Map source requirements
Use a local versioned source library and deterministic rules before any optional AI support is considered.
Create review evidence
Produce risk-coded findings, source references, comments, and proposed revision language for human review.
Package for approval
Prepare editable drafts, redlines, clean copies, PDF reports, and audit trail records for qualified reviewer approval.
Source library
Official references stay visible and version-aware.
RegAudit separates source-linked review from unsupported assumptions. When a monitored source changes, it requires human review before rules are updated.
FDA RWD/RWE guidanceLocal libraryTracked
21 CFR and electronic recordsRegulatory mapTracked
Digital health and remote acquisitionEvidence contextTracked
eCFR and Federal Register monitorsWeb/API checkTracked
19Sources in current local library
22Official targets monitored for version changes
0Current sources requiring review in the last check
Review package outputs
Built around evidence, redlines, and document control.
Every output should be editable where appropriate, exportable when authorized, and traceable to the source snapshot used during review.
Finding table
Severity, document section, source basis, evidence, remediation, and reviewer status.
Redline draft
Proposed revisions with comments tied to source references and finding IDs.
Clean copy
Editable corrected document after accepted changes and review controls.
PDF report
Readiness score, source map, findings summary, and reviewer acknowledgement.
Audit trail
Control number, timestamp, source snapshot, reviewer route, and package version.
Commercial packaging concept
Start private. Scale when the product is ready.
These are positioning tiers for a future commercial site, not active public purchase flows.
Private Workspace
For personal/local use and early product validation.
- Local source library
- Document review package preview
- Manual reviewer approval gate
Professional Review
For structured document readiness workflows and controlled outputs.
- Expanded source monitoring
- Editable redline and clean drafts
- Control number and audit trail
Enterprise Library
For teams that need policies, templates, libraries, and review routing.
- Team review gates
- Custom source library controls
- Submission package governance
Safety boundaries
Conservative claims by design.
The product should accelerate review preparation without claiming regulatory approval, acceptance, clearance, or certainty.
No regulatory determination
RegAudit does not provide FDA review, approval, clearance, acceptance, compliance certainty, or regulatory determination.
Human approval required
Generated material is reference support only and requires qualified/certified reviewer approval before use.
Source versioning required
Official references should be checked before final outputs, and changed sources require human review.
RegAuditRWE.com
Coming soon for private beta access.
Use the public site to introduce the product and collect qualified interest. The actual workspace remains gated, private, and reviewer-controlled until deployment controls are ready.
Direct contact: contact@regauditrwe.com