Complaint handling software for pharma and medical devices: triage, adverse event check and investigation

What the module does

• Intake from email, call center, web form, distributor, sales representative or other channels: the complaint text pasted as received with personal identifiers removed, the original attached as a PDF or Word document, or both, under a CMP number.
• Supporting documents (correspondence with the reporter, a distributor's report, test data, photos of the defect) attached to the record, fingerprinted, audited and read by the AI with the complaint.
• An AI-drafted complaint record: a summary, the product, lot or batch, event date, reporter, category, patient involved, harm reported and sample available, each with the exact quote it rests on, highlighted in the complaint text.
• Eight complaint categories: product quality, container closure or packaging, labeling, lack of effect, patient reaction, device or delivery system, suspected counterfeit or tampering, and other.
• An adverse event check: a possible adverse event is flagged with its rationale and a banner to route it to pharmacovigilance for assessment, with flags, missing information and suggested next steps listed for the reviewer.
• The reviewer's route: route to pharmacovigilance, open an investigation, trend only, or not a complaint and close; the first decision needs no reason, a change does.
• Confirmation of receipt emailed to the reporter from the record, prefilled with an AI acknowledgement that gives no medical advice and admits no fault, with the email logged on the record.
• A preliminary investigation evaluation: the problem statement with IS / IS NOT, patient safety and product quality impact, other lots that could be affected, whether a regulatory or pharmacovigilance reporting assessment is needed, a suggested priority, hypotheses across the 6M categories and next steps with owner roles and timing.
• The root cause investigation started from the complaint, with its text, summary, problem statement and the reviewer's note as the write-up, linked back to the complaint as its origin.

How it fits the platform

A complaint opened for investigation becomes an investigation in the Investigations and CAPAs module, and the approved investigation opens the CAPA and, where needed, the change control. Connected records suggest other records that share the lot, product, equipment or cause wording, so a complaint on a lot already under deviation is seen next to it. Complaint rates can be trended in signal detection, and backlog triage ranks open complaints with the deviations and CAPAs by risk.

Built-in alerts raise a possible adverse event without a decision as critical after 24 hours, and a complaint awaiting a decision after 5 days. Q Agent can log a complaint, open the investigation and draft the root cause analysis, each action waiting for a person's approval.

Where people decide

The AI drafts the complaint record, the adverse event flag, the acknowledgement and the preliminary evaluation; it never decides that an event is an adverse event, decides reportability or closes the record. The reviewer checks every field and edits with a reason, decides the route and the priority under the site's SOP, accepts or rejects each next step, and routes the complaint for review and approval with electronic signatures.