Pharmacovigilance you can prove.

No. A template builds the narrative from the structured data you already entered, and you edit it from there. Edits are audited like any other field, so an earlier wording can be recovered. Drafts save themselves, and a case can be copied into a new one.

The system holds each product's listed terms with an effective date and country, and works out expectedness against the list in force on the date of the reaction, not the one in force today — the distinction an assessor challenges.

You can override it. The override needs a reason, and the system's own answer is kept beside yours.

It becomes a new version linked to the previous one, with the chronology visible from the case. Significant new information opens a new 15-day clock from the date you received it, and the change of due date is recorded.

The second save is rejected, and you are shown what changed while you were editing. Nothing is ever overwritten silently — a quietly lost edit is the kind of thing you only discover during an audit.

Yes. The stages, who may move a case between them, and a separate route per case type are all configurable. Reporting timelines and warning thresholds are yours to set, without asking us for a change.

CIOMS forms, the original email, clinical reports — attached and classified on upload, so you can list the cases with no source document instead of finding out during the audit. Encrypted, hashed, and opening one is itself recorded.

A compliance report per period and per client lists what was on time, what was late and what is pending. Per case, a tracking view shows when it entered each stage, how long it stayed, and who moved it on.

A single PDF per case with the data, the state history and the audit trail together. Any listing, carrying a header with who produced it, when, the filters and an export identifier — and that identifier sits in the audit trail, so the file in their hands ties back to the moment it was generated.

Plus the user access listing — role, organisations, last access — which is what they ask for when they check your periodic access review.

Five, and the boundaries between them are the point — separation of duties is one of the first things an auditor checks:

• Data entry — creates and edits draft cases.
• Reviewer — reviews, approves, or returns a case with comments.
• PV responsible / QPPV — locks and unlocks with a reason, sets the timelines, sees the metrics.
• Auditor — read-only over cases and the full audit trail, with export. This is the login your client's auditor gets.
• Administrator — manages users and configuration, and cannot edit case data.

And no role — the administrator included — can modify the audit trail.

Permissions go by role, so someone entering cases cannot approve one. Approval asks for the password again and records the signatory, the time and what the signature meant. Each signature is tied to the exact content that was signed: if the record is altered afterwards, the system shows that the signature no longer matches.

No — and be careful with any vendor who claims theirs is. Validation is demonstrated for one specific installation, with your users and your procedures. A claim made about the product in general glosses over the part that lands on your desk.

What Vigila does is produce the evidence as it is built: every requirement has a permanent identifier, every test names the requirement it proves, and the traceability matrix comes out of the system itself — not written by hand afterwards.

The documentation written and sent to you to review, approve and sign — and brought up to date whenever the system changes. Help drafting your own validation procedure. And the evidence itself when an auditor asks for it.

It is in the monthly fee. No ticket, no hourly invoice.

Configuration, migration, documentation and upkeep are mine. Yours is what only you can do: approving the requirements, signing what you sign, and running the acceptance testing with your own people. A supplier who offers to sign your procedures for you is selling you a future finding.

Yes — it is the case Vigila was designed for, not an option bolted on. Separation is built into the database itself, so a user assigned to one client cannot reach another's cases by any route, including editing an identifier in the address bar.

In the European Union, only. Adverse-reaction data is special-category health data and is treated that way: encrypted in transit and at rest, encrypted attachments, no personal data in technical logs, a data-processing agreement, no transfer outside the EU.

A full copy every day and a further copy every four hours, stored encrypted and away from the main system. At most four hours of data at risk, and back in service within eight hours.

Backups are regularly restored into a separate test environment, and the result is reported automatically — a backup nobody has ever restored is a claim, not a control.

You take everything — cases, attachments and the full history — in an open format, per client. Built in rather than negotiated, because being able to leave is what makes staying a decision.

The data is E2B(R3)-structured from the first record and coded fields already carry the dictionary and its version, so MedDRA coding and XML generation can be added later without touching your data. They are not in the first release, which closes the gap that actually hurts: a proper register with a proper history.

A MedDRA subscription, when you need one, is licensed by you from the MSSO and is not resold here.

At these volumes, no. Exporting the XML and uploading it through EVWEB or EVPOST is what the EMA expects from small and medium organisations, and it removes the most expensive piece of the usual project.

The first release is pharmacovigilance. The structure is not hostile to the others, but claiming them today would be the overclaim this page is trying to be the opposite of.

Vigila is in development and no public date is promised here: a date on a website is a commitment made before knowing your situation. Send me your own deadline — a contract, an audit, a client start date — and you get a straight answer against it.