Feedbacks and complaints shall be taken seriously. Behind every Feedback is an opportunity. Behind every complaint is a patient, a clinician, a user, a story. And possibly: a risk.

With the Aligned eQMS Feedback and Complaint form, you collect and triage inputs and communication from stakeholders in a compliant manner, aligned with ISO 13485 8.2.1 and 8.2.2

A formal decision process, supported by e-Approvals gives you the compliance proof necessary to show that you did the right thing.

When a product does not meet specifications, be it incoming goods, goods in production or delivered devices, the Aligned eQMS is the principal place to track it.

Record containment, marking and storage actions taken to isolate the non-conforming product. Track product specific information such as batch ids, quantities, and timelines.

Create and assign Tasks to your team for parallel and swift resolutions. Monitor the status and ensure full closure ,all with real-time visibility.

When necessary, escalate the matter to a Nonconformity Assessment for deeper investigation and root cause analysis.

A nonconformity can originate from a number of situations and be related to a range of different quality artefacts.

It can be the result of an escalated Complaint. It can arise as an outcome of an Audit. It can emerge from a failed Computer Software Validation.

In the Aligned eQMS, Nonconformity Assessments are stored in a single location with clear references to other parts in the eQMS.

Get the full picture through detailed situational information collection and clear decision points, signed with e-Approvals and proper justifications.

Make use of a guided and thorough Root Cause Analysis process and set up association with similar Nonconformity Assessments. If necessary, escalate the situation to one or more CAPAs.

CAPA is the heart of an ISO 13485 compliant quality system and the most scrutinized part during audits.

We help you go beyond reactive fixes to proactive improvement, with structured steps and bulletproof documentation.

Define action plans with accountability, complete with owner, due date and assessment. Support your implementation with objective evidence of implementation and of effectiveness.

Ensure CAPAs are only closed when actions are complete, verified, and approved by designated roles.