InFlow-PV Pharmacovigilance Software
Case intake, case processing and aggregate safety reporting for drug-safety teams, with an audit trail on every step.
What Pharmacovigilance Software Does, and Who Runs It
Pharmacovigilance is the set of activities a marketing authorization holder or a contract safety organization runs to detect, assess and prevent adverse effects from a medicine already on the market. Pharmacovigilance software is the system that carries that work: it takes in an adverse event report, moves it through medical review, and produces the reports regulators expect on a fixed schedule. InFlow-PV is CORPEX's system for that job.
Day to day, the people in InFlow-PV are drug-safety officers doing intake and case processing, PV physicians doing medical review and causality assessment, and the QA staff who sign off before a case or an aggregate report goes out. In a company that also runs CORPEX eQMS, the same audit-trail and electronic-signature model carries over, so a safety case behaves like any other controlled record in the quality system rather than a separate island of data.
How a Case Moves Through InFlow-PV
InFlow-PV carries an adverse event report from first contact through to a closed, reportable case, with each stage documented and attributable to the person who performed it.
1. Case Reception
Reports reach a company from many directions — call centers, sales representatives, literature screening, clinical studies, regulatory authorities. InFlow-PV logs each one centrally with the date first received, because that date starts every downstream reporting clock.
2. Case Validation
Every report is checked against the four minimum criteria for a valid case: an identifiable patient, an identifiable reporter, a suspect drug and a suspect adverse event. A case missing any of the four is tracked as incomplete pending follow-up rather than dropped.
3. Safety Data Entry
Valid cases are entered in structured form aligned to the E2B data elements, so the case can be exchanged electronically with regulators and partners instead of being retyped for every submission.
4. Quality Control
A second reviewer checks the entered case against the source document for completeness and accuracy before it reaches medical review — the same second-check principle used in a GMP QC laboratory.
5. Medical Review
A PV physician assesses causality and seriousness. The reaction and indication are coded against a standard dictionary such as MedDRA, so cases from different sources can be compared and aggregated consistently.
6. Reporting
InFlow-PV generates expedited individual case safety reports (ICSRs) for reportable cases, and periodic aggregate reports (PSURs/PBRERs) that roll up everything observed for a product over the reporting period.
The Regulatory Requirement Behind Every Case
Every reportable adverse event carries a filing clock. Once a case meets the minimum criteria, expedited reporting timelines apply under the frameworks that most regulators follow — in the US, 21 CFR 314.80; in the EU, the GVP modules; and, for the electronic message format itself, ICH E2B(R3), the international standard for structuring and transmitting an individual case safety report so it can move between a company's safety database and a regulator's without being retyped.
Aggregate reporting exists because a single case rarely tells the whole story. A PSUR or PBRER rolls up every case seen for a product across the reporting period, and it is in that cumulative review — not any one case in isolation — that a genuine safety signal usually first becomes visible. That is why case-level data quality matters even when a single report looks routine: it is the raw material the next aggregate report is built from.
What an Inspector Checks in a Pharmacovigilance Audit
A PV inspection is less about any single case and more about whether the system behind it is consistent, timely and traceable. The records InFlow-PV keeps are built to answer these questions directly:
- Timeliness: was the reporting clock started on the date the company first received minimum information, and was the expedited report filed within the required window.
- Follow-up: does an incomplete case show a documented follow-up attempt rather than sitting unresolved.
- Consistency: is causality assessment and MedDRA coding applied the same way across reviewers and cases.
- Traceability: who validated the case, who performed medical review, who approved dispatch — each step timestamped and unchangeable once signed.
Where InFlow-PV Connects to the Rest of the Quality System
Not every adverse event walks in the door labeled as one — many start as a customer or physician complaint. Connecting InFlow-PV's intake to CORPEX complaints management means a report raised through that channel does not get missed or handled twice.
Because a safety case is itself a controlled quality record, InFlow-PV shares its audit-trail and electronic-signature model with the rest of CORPEX eQMS software, so drug-safety governance sits inside the same reviewed system as document control and CAPA rather than running on a separate set of rules.
Aggregate reports and case history also feed the regulatory dossier: RENOVA-RDX organizes the CTD submissions, licences and regulatory approvals that a PSUR or PBRER ultimately supports, so the safety and regulatory affairs teams are working from the same product history.
Implementation and Validation
A pharmacovigilance system is a GxP computerized system, which means deploying it is itself subject to validation before it can be relied on for regulatory reporting. CORPEX runs computer system validation (CSV) alongside implementation — a validation master plan, IQ/OQ/PQ testing, and the documentation package an inspector will ask to see — so InFlow-PV is inspection-ready at go-live rather than validated after the fact.
Pharmacovigilance Software in Egypt
The Egyptian Drug Authority (EDA) operates a national Pharmacovigilance Center and publishes Egyptian Good Pharmacovigilance Practice (GVP) guidelines that marketing authorization holders and manufacturers follow for adverse drug reaction reporting — part of Egypt's participation in the WHO Programme for International Drug Monitoring. CORPEX Informatics is an Egyptian company headquartered in the New Administrative Capital, and builds InFlow-PV with that local reporting context, Arabic-language support, and on-site implementation in mind, alongside the eQMS software CORPEX already delivers to Egyptian pharma and manufacturing companies. For the full local picture, in English and Arabic, see pharmacovigilance software in Egypt.
Benefits of the InFlow-PV Monitoring System
Regulatory Compliance
Case processing and reporting built around the timelines and record-keeping that FDA, EMA, WHO and EDA drug-safety reporting expects.
Operational Efficiency
Structured intake and E2B-aligned data entry cut the manual effort and processing time behind every individual case safety report.
Data Integrity
Validation checks and audit trails at every stage keep safety data consistent from intake through the final aggregate report.
Cost Savings
Fewer late filings and rework mean lower compliance costs and less exposure to regulatory penalties.
Pharmacovigilance Software — Frequently Asked Questions
What does pharmacovigilance software actually do?
Pharmacovigilance software takes in adverse event reports from any source, validates that they meet the minimum criteria for a case, routes them through quality control and medical review, and produces the individual case safety reports and periodic aggregate reports (PSURs/PBRERs) that regulators require. InFlow-PV runs that process end to end with an audit trail on every step.
What is an ICSR and when does one have to be filed?
An Individual Case Safety Report (ICSR) is the structured report of a single adverse event. It becomes reportable once a case has the four minimum criteria: an identifiable patient, an identifiable reporter, a suspect drug and a suspect adverse event. From that point, expedited reporting timelines apply, which is why the intake date is recorded precisely in InFlow-PV.
Does InFlow-PV support E2B(R3) case data?
InFlow-PV's safety data entry is structured to align with the E2B(R3) data elements that ICH defines for exchanging individual case safety reports electronically, so a case does not have to be re-keyed for every downstream submission.
What is the difference between a PSUR and a PBRER?
Both are periodic aggregate safety reports covering everything observed for a product over a defined period rather than a single case. PBRER (Periodic Benefit-Risk Evaluation Report) is the ICH E2C(R2) format most regulators now expect; PSUR is the term still used in some markets and legacy filings. InFlow-PV generates both from the same underlying case data.
How does pharmacovigilance work in Egypt?
The Egyptian Drug Authority (EDA) operates a national Pharmacovigilance Center and publishes Egyptian Good Pharmacovigilance Practice (GVP) guidelines that marketing authorization holders and manufacturers follow for adverse drug reaction reporting. CORPEX is an Egyptian company and builds its systems, including InFlow-PV, with that local reporting context and Arabic-language support in mind.
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Talk to CORPEX about deploying InFlow-PV for your pharmacovigilance operation.