Access review
Confirm role, use case, expected document workflow, confidentiality acknowledgement, and whether local-first operation fits the project boundary.
Demos and licensing by direct contact - commercial terms shared privately
FDA real-world evidence readiness, organized for the qualified reviewer.
RegAudit RWE audits RWD/RWE protocols, analysis plans, and data source documents against current FDA guidance, scores relevance and reliability, tracks data lineage, and assembles a reviewer package with source-linked findings and proposed revisions. Regulated document work stays inside authorized private workspaces.
Commercial access structure
License access is reviewed by deployment fit, not handled through public checkout.
RegAudit RWE is positioned for controlled local license access. Commercial details are shared privately after scope, reviewer responsibilities, data boundaries, and deployment mode are understood.
Local license scope
Select an individual, professional, regulated-team, or private-deployment path after review. No public checkout or self-serve commercial terms are shown.
Controlled setup
Align source-library scope, document-control expectations, reviewer gates, privacy restrictions, and optional implementation support before use.
Reviewer approval boundary
Outputs remain reviewer-support material. The intended output label is “Regulatory-ready draft for qualified reviewer approval.”
No public checkout, no public commercial terms table, and no public document intake. License details are handled through direct access review. Prefer a done-for-you review? Ask about the fixed-scope Readiness Review Service.
Local-first - private - review preparation
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.
29SourcesIn library
32Monitored targetsActively tracked
QAReviewer gateRequired before use
LocalProcessingPrivate by default
FDA21 CFR, RWD/RWE guidance, final delivery controls
openFDAPublic FDA API context for device and safety signals
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 -> Reviewer Draft
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.
Classify the document
Identify file type, review pathway, sensitivity status, and expected output package before analysis begins.
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
29Sources in current local library
32Official targets monitored for version changes
0Source monitor changes pending human review
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 reviewer draft 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.
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.
Legal & policy notices
Clear boundaries before any controlled deployment.
Effective date: October 22, 2026. These notices cover the public contact channel, product positioning, and the owner-only workspace boundary while commercial hosted processing remains disabled.
Launch boundary: RegAudit RWE is preparing controlled license access for local-first regulatory-readiness workflows. The public site does not accept source documents, does not generate public outputs, and does not provide legal, medical, clinical, regulatory, or FDA determinations.
License review only
Terms
Access, use, reviewer responsibility
Privacy
Contact data and email
License Access
Local licenses and private terms
Safety
Reviewer-support boundary
AI Notice
Assistive use and limits
Acceptable Use
Controlled review workflow
Source Versioning
Human review for source changes
Security
Local-first and hosted boundaries
Sensitive Data
PHI/ePHI and confidential material
Contact
Legal, privacy, source, security
Terms of Use
The public site is for product information and license-access interest only. Access to any workspace, hosted service, professional service, or customer deployment may require separate written terms.
- Do not send confidential, PHI/ePHI, patient, sponsor, trade-secret, or regulated source material by email or through the public site.
- Regulatory-readiness support for qualified reviewer preparation.
- Users remain responsible for source applicability, final decisions, reviewer sign-off, and document control.
- License and commercial materials are confidential unless separately authorized in writing.
- Software access does not transfer ownership, resale rights, sublicensing rights, or reverse-engineering rights.
Privacy Policy
The public site has no request form. When you email contact@regauditrwe.com, the message and the details you choose to include (such as name, organization, and role) are used only to reply to your inquiry.
- Email is received through the domain's mail forwarding provider and the owner's mailbox.
- The public site does not use advertising or tracking cookies.
- No public workflow is configured for uploads, project files, PHI/ePHI, patient data, or sponsor-confidential material.
License Access
RegAudit RWE is handled through controlled license access, not public purchase flows, self-serve checkout, or public commercial terms tables. License details and pricing are shared on request, after access review, deployment fit, confidentiality acknowledgement, and data-boundary discussion. Software licenses are annual, renewable terms.
Readiness Review Service
A fixed-scope review of your protocol, statistical analysis plan, or data source package, delivered by the RegAudit RWE team. No software installation needed.
- Findings mapped to current FDA RWD/RWE guidance
- Proposed revision language and relevance and reliability scores
- Delivered to your qualified reviewer for final decisions
Pricing on request
Individual Local License
For one named consultant, reviewer, auditor, medical writer, or QA/regulatory specialist working locally.
- Downloadable local installation
- Document findings and redline draft support
- Basic reviewer handoff package
Pricing on request
Professional Local License
For consultants, boutique regulatory firms, and small teams handling repeated document revisions.
- Multi-project document workspace
- Source-linked findings
- Traceability and reviewer packet support
Pricing on request
Regulated Team Local License
For regulatory, quality, sponsor, device, or CRO teams that need shared review controls.
- Role-based access and program workspaces
- Privacy, language, and reviewer gates
- Controlled package tracking
Pricing on request
Enterprise Private Deployment
For organizations requiring dedicated installation, custom policies, integrations, and formal support.
- Private deployment planning
- Custom source library and template scope
- Training, support, and integration options
Pricing on request
- Maintenance, training, custom source libraries, implementation, document package support, and reviewer handoff support are scoped separately.
- Software access does not transfer ownership, resale rights, sublicensing rights, or reverse-engineering rights.
- Commercial materials remain confidential unless separately authorized in writing.
Safety & Regulatory Notice
RegAudit RWE supports reviewer preparation. It is not affiliated with FDA, and use of public FDA materials does not mean FDA has reviewed, endorsed, authorized, or approved RegAudit or any output.
- Outputs are informational drafts and reviewer packets.
- Qualified reviewer approval, source verification, and local change control are required before use.
- FDA guidance documents generally describe current thinking and may not be binding unless statute or regulation is cited.
AI Support Notice
AI support, where enabled inside an authorized workspace, may assist with classification, extraction, mapping, redline drafting, and QA. AI is support only.
- AI does not replace source verification, deterministic rules, qualified reviewer judgment, legal/regulatory review, or sponsor responsibility.
- Cloud AI must not be used with PHI/ePHI, PII, confidential sponsor data, trade secrets, or NDA materials unless authorized controls and agreements are in place.
- AI outputs may be incomplete, inaccurate, outdated, or inapplicable.
Acceptable Use
RegAudit must be used as a controlled review-support environment, not as a shortcut around institutional, regulatory, privacy, or quality responsibilities.
- Do not misrepresent outputs as FDA determinations or final regulatory decisions.
- Do not upload or process data without authorization, consent basis, privacy review, and source rights.
- Do not remove safety notices from reviewer-facing exports or rely on unsupported claims.
Source Versioning
RegAudit monitors selected official and curated sources where feasible. Monitoring supports review; it does not guarantee every applicable requirement, guidance, standard, policy, or jurisdiction is complete or current.
- Changed, stale, unreachable, or unverified sources require human review before baseline updates.
- Paid or copyrighted standards are not bundled unless properly licensed.
- The current source monitor has one change pending human review.
Security & Local-First
Security protections depend on deployment mode. Local projects depend on the user's device, browser storage, backups, access controls, and endpoint security.
- The public site is a product information and contact surface.
- The owner workspace is private and protected; public routes for internal files remain blocked.
- Hosted sensitive-data mode requires security review before use.
Sensitive Data / PHI Notice
RegAudit is not configured for PHI/ePHI in hosted or cloud-AI mode unless a HIPAA-enabled deployment, BAA pathway, security controls, access controls, and breach-response process are in place.
- Do not send PHI/ePHI, PII, or confidential sponsor material by email or through the public site.
- Private workspace use should classify data before import, parser review, AI support, handoff, or export.
- De-identification, privacy basis, and reviewer approval remain user responsibilities.
Incident & Contact
Report legal, privacy, source-version, or security concerns before sharing regulated or sensitive material.
- Legal and privacy contact: contact@regauditrwe.com.
- Commercial, hosted, customer, DPA, BAA, or professional services terms require separate review.
- These notices are not a substitute for licensed attorney, privacy, security, or FDA regulatory counsel review.
RegAuditRWE.com
Request a demo or licensing details.
Ask for a demo, a software license, or a fixed-scope Readiness Review of your protocol and data source package. Tell us your role, your organization, and what you need to review: the product type, the data source, and the regulatory objective. Pricing is shared on request after a short fit review and a confidentiality acknowledgement.
Write to
contact@regauditrwe.com- Every message gets a personal reply.
- Individual consultants, regulatory teams, and private deployments.
- Please do not send patient data or confidential documents by email.
RegAudit RWE is not affiliated with FDA. No output represents FDA review, approval, clearance, or acceptance.