Available today
In every workspace, including the 30-day free trial.
Included in your free trial- Products, versions and lotsYour products, versions and lots from your own exports, so every complaint, signal and case sits on the right product version and lot.
- A second look at closed complaintsComplaints closed as inquiries or “no fault found” are brought back for review, so a reportable event is not lost in the wrong category.
- Reporting clocksFDA, EU, UK and Canada reporting windows counted from the day you became aware, with each reportability decision and its reason kept.
- Complaint signalsA count rule and a trend check per product version raise a signal when complaints rise, before anyone has to spot it in a spreadsheet.
- InvestigationsEvidence, competing hypotheses and open questions side by side, so a conclusion shows what supports it and what is still unknown.
- Signed human decisionsDecisions signed with your password and authenticator code. Whoever writes a brief never reviews or signs it, and every step is in the audit trail.
- CAPA effectiveness and inspection readinessPlan and sign the effectiveness check, send input to the risk file, and download the inspector summary as one pack.
- Import your own exportsCSV or Excel with your own column names, guided by templates. Personal details are refused or replaced before anything is stored.
- Roles, administration and MFAWorkflow roles with separation of duties, customer administration, and authenticator-app MFA on every account.
Start on sample data, then on your own exports. No integration and no credit card.