AllesEra · QPPV Agent
Inspection-ready PV, built for the accountable QPPV
A precision cockpit for Egyptian pharmacovigilance: Cairo deadlines, E2B export readiness, PSUR assist, system-document packs, and audit evidence your team can walk an inspector through. Never replaces a validated safety database.
Your systems hold the cases. QPPV owns the QPPV role.
Illustrative records — not a live MAH case. Sign in is for provisioned accounts.
Your stack, not another safety database
Case systems
Intake, coding, and E2B reporting path
QPPV Agent
Deadlines, drafts, packs, and inspection evidence
EDA inspection
Documented control the QPPV can demonstrate
What the inspector asks. What the tool surfaces.
| Inspector asks | Tool surfaces |
|---|---|
| Show all ESI reports in the last 90 days | ESI tracker with Cairo calendar stamps |
| Demonstrate the 15-day ICSR chain | Case log, workflow states, audit trail |
| Show PSMF / PSSF filing evidence | Versioned packs with human attestation |
| Evidence of signal assessment | Signal log with documented outcomes |
Live today — PV arm
| Capability | Outcome for the QPPV |
|---|---|
| Case intakeLive | Structured draft, validation gates, medical review path |
| ICSR trackerLive | Workflow through E2B R3 export and submission package ZIP |
| Signals & ESIsLive | Cairo calendar with five working-day ESI logic |
| Case metricsLive | Read-only trends by product, status, and month |
| PSUR / PBRERLive | AI-assisted periodic drafts with Egyptian national appendix hooks |
| RMP / aRMMLive | Product-level risk plan drafting (GVP Ch.5) |
| PSMF / Summary / PSSFLive | Versioned system docs; attestation before filing-ready |
| Literature & auditLive | Monitoring log, promote-to-case, global audit feed |
| English-locked marketing + PV OSLive | Public AllesEra chrome and authenticated PV OS are English only |
Illustrative sample pack
See the shape of export and inspection artefacts a named QPPV can download — E2B-shaped XML, audit trail, PSMF excerpt, signal/ESI register. Fictional fixtures only. Not a live MAH case. Not for EDA filing.
v1.5 — one workstation, two arms
Regulatory Affairs joins pharmacovigilance on a single MAH workspace: shared product master, org-scoped audit, plan entitlements, and team seats for enterprise MAHs.
| Capability | Outcome for the QPPV |
|---|---|
| Regulatory Affairs armv1.5 | Registration portfolio, submission tracker, deficiency log, RA Q&A corpus |
| Team seatsv1.5 | Accountable QPPV, PV officers, read-only QA on one org |
| Health Check funnelv1.5 | Free five-pillar gap assessment → platform / retainer upgrade path |
| Enterprisev1.5 | PV + RA, pooled AI, org branding, sales-assisted provisioning |
| Regulatory Q&A surfacev1.5 | EDA-cited answers as a separate AllesEra surface — not restored to the PV cockpit sidebar (#517) |
How we engage
Platform seats, named PV retainers, and advisory are scoped against your portfolio in writing. Rates are not published on this page.
Five-pillar gap assessment in about five minutes — start before a commercial conversation.
SaaS seats for the named QPPV and authorised PV team in a dedicated MAH organisation.
Named delivery days, optional QPPV designation, and scoped RA / quality / serialization advisory.
Book a walkthrough or send a written RFP. Credentials are provisioned — they are not published here.
Does AllesEra e-sign or submit to EDA?
No. A named QPPV attests and stays legally accountable. AllesEra drafts and tracks. The app never e-signs and never submits to EDA.
Does QPPV Agent replace a validated safety database?
No. Your case systems hold the cases. QPPV Agent is the accountability cockpit above them — deadlines, cited answers, drafts, and inspection evidence.
What is the difference between RMP, PSMF, and PSSF?
RMP / aRMM is product-level (GVP Ch.5). PSMF is the pharmacovigilance system master file (GVP Ch.2). National PSSF is the Egypt summary. AllesEra keeps them on separate pages and never bundles them into one artefact.
Is the PV OS available in Arabic?
AllesEra marketing and this product home are English-locked. PV OS chrome (attest, ICSR, packs) is English only.
Operational autopilot — the named QPPV remains legally accountable and must attest before filing-ready packs. AllesEra never signs or submits to EDA and is not legal or medical advice.