Quality risk management software for FMEA under ICH Q9(R1)
The QLogix risk assessment module is quality risk management software that runs each failure mode and effects analysis (FMEA) as one audited, signed record, from the first draft to the acceptance of the residual risk. An assessment starts from a design, process, equipment or CSV FMEA template; the AI drafts the register from the description of the subject, the attached documents and the linked records, and the team scores severity, occurrence and detection. RPN thresholds from the organization's risk management procedure class every risk Critical, High, Medium or Low and fix its follow-up. Critical and High risks carry mitigation actions with owners, due dates and expected scores, are reassessed from evidence once implemented, and the residual risk is accepted by QA with a justification or sent back for further action.
What the module does
- Four templates: design FMEA (dFMEA) for a product, formulation, container closure or device design; process FMEA (pFMEA) for a manufacturing, packaging or laboratory process; equipment FMEA for equipment, a facility or a utility; and CSV FMEA, the GAMP 5 functional risk assessment of a computerized system.
- Guidance in each template for the item, failure mode, effect, cause and controls, the sources the AI reads (batch records and deviations, maintenance and calibration records, the URS and supplier assessment) and a worked example on the form.
- An AI-drafted register: the summary, method, assumptions and questions for the team, and 8 to 150 failure modes scored 1 to 10 for severity, occurrence and detection, with a mitigation action, owner role, due date and expected scores for every Critical and High risk.
- The risk priority number (RPN = S × O × D) classed against thresholds set from your procedure; by default Critical at an RPN of 200 or a severity of 9 and above, High at 100, Medium at 50. Changing a threshold reclasses the whole register and needs a reason.
- Rescoring, additions and removals each with a reason in the audit trail; a register view ranked by RPN with the Pareto, the severity by occurrence matrix and the rating scales.
- Mitigation tracking: actions assigned to named people, who are emailed, with statuses from planned through implemented to verified effective, and evidence files (change control closure, test report, training record) fingerprinted and linked to the row.
- Post-mitigation reassessment of severity, occurrence and detection from the evidence, with the residual RPN and class; a residual at or above the acceptable RPN needs further action or QA's acceptance with a justification.
- The risk assessment report as a locked PDF with the register, follow-up, reassessment, signatures and audit trail; every export is logged.
How it fits the platform
The AI drafts from what is attached or linked to the assessment: batch records, deviations and specifications for a process FMEA, maintenance and calibration records for an equipment FMEA, the URS and supplier assessment of a computer system validation for a CSV FMEA. A mitigation that changes a process, a procedure or a piece of equipment is carried by a change control or CAPA linked to the assessment, and the reassessment rests on its evidence.
Q Intelligence can also build a draft FMEA or PFMEA in the conversation from deviations, investigations and SOPs, ranked by RPN, for the team to review. The formal, controlled assessment is a risk assessment record, listed in document management's index with its signatures and audit trail.
Where people decide
The AI drafts the register and proposes scores and actions; the cross-functional team rescores with reasons, owners implement the actions and attach the evidence, and the assessment is approved with electronic signatures. QA accepts any residual risk that stays at or above the acceptable RPN, with a justification, and closure signs and locks the record. The AI never accepts a risk.
Questions about Risk assessment
What is FMEA in pharma?
Failure mode and effects analysis (FMEA) lists how a process, product, piece of equipment or computerized system can fail, what the effect would be and why it would happen, then scores severity, occurrence and detection to rank the risks. ICH Q9(R1) names it among the tools of quality risk management. The ranking decides where controls and mitigation go first.
What is a risk priority number?
The product of the severity, occurrence and detection scores, each from 1 to 10. QLogix classes each risk against thresholds set from your risk management procedure. Because controls do not change severity, a failure mode at the critical severity keeps its class after mitigation and stays visible for review.
What is the difference between a pFMEA and a dFMEA?
A design FMEA examines a product, formulation, container closure or device design, function by function against its design requirements. A process FMEA examines the steps of a manufacturing, packaging or laboratory process against their parameters and limits, with causes grouped in the 6 Ms. QLogix also has equipment and CSV FMEA templates.
How are mitigation actions tracked?
Each action has an owner, a due date and the expected scores, and moves from planned to implemented, with evidence, and verified effective. Once it is implemented the row is reassessed from the evidence, and the residual RPN shows whether the risk is mitigated or needs QA's acceptance.
Can the AI accept a risk?
No. The AI drafts the register and proposes scores and actions; people rescore with reasons, implement and evidence the actions, and QA accepts any residual risk that is not acceptable, with a justification. Approval and closure are signed electronically.
How is it licensed?
Per user per month, on its own or with other modules, ordered by purchase order from the client portal. There is no card payment or self-serve plan.
Reading
Other modules
- Regulatory submissionsRegulatory submissions software: post-approval changes screened per market, NDA and BLA sections drafted on an eCTD template, every claim quoted from its source.
- LIMSLIMS for pharma QC laboratories: approved specifications, results judged by the system, OOS under investigation, calibration lockouts and a signed CoA.
- Electronic lab notebookAn ELN for the QC laboratory: effective methods, equipment checked across LIMS, calibration and CMMS, observations never edited, results posted to the LIMS.
- MES (electronic batch records)MES for pharma with electronic batch records: your master batch record, every step signed and verified, review by exception, ERP orders and QA release.
- GMP logbooksElectronic logbooks for GMP cleanrooms, equipment and instruments: system-stamped entries, second-person verification, never edited, periodic reviews signed.
- PM LibraryA particulate matter library for fill-finish: defects characterized with images and FTIR, approved by QA, and current kits for inspector and AVI qualification.