Eliminate inefficiencies associated with quality event processes by removing excess documentation and automating your quality event processes.
With customizable workflow templates created by you, incorporate specific, detailed steps following your company's protocol to automate the step-by-step process. Keep a single, up-to-date workflow with management controls in place for your complaint process.
Automate your workflow inside your QMS to help you track the correct action items to the right user or group - increasing your team's efficiency.
Fully understand everything that is impacted by a complaint by visualizing the links and relationships in a centralized view.
Uncover patterns or multiple instances of a similar type of feedback, maybe it is a training issue or another type of systemic issue that requires a CAPA.
Be in control of your quality data and understand the trends and impacts it has on your quality system, your device(s), and your organization.
Capture, document and log all types of customer feedback including complaints. Yes, we must react to complaints and do something about it. If a complaint is identified as a systemic issue, then escalate it to a CAPA. If a complaint can be handled then and there, handle it (and document it and learn from it). Escalate a complaint to a CAPA only when necessary, which eliminates misuse of CAPA and doesn’t bog down your processes.
Feedback in any form is a good thing. Most companies don’t have the mechanisms in place to collect feedback today so it gets lost, and hinders you from optimizing that feedback in a full product lifecycle.
There is good stuff coming from your customers. Listen to it and do something about it. Their design suggestions, even simple things like color, grip or other suggestions, can feed right back into the development process positively impacting the effectiveness of the product.
Listening to feedback from your market allows you to make much better decisions based on data and helps you to focus on True Quality in your products.
Quickly determine whether the feedback requires immediate action to determine if regulatory reporting is required. If it is, automatically initiate a task for someone to generate the report that needs to be sent to the FDA and document that decision for future reference.
Assign customer feedback related tasks to your team and track everyone’s progress towards due dates. Ensure your customer complaint processes are compliant and easily audited by regulatory bodies in any country. Optimize customer feedback management and oversight for faster response times.
In the development process, assessing risk is a “best-guess” effort. Once you’ve launched your product, you now have confirmation that you’ve captured the appropriate risks and acceptability, since feedback and complaints are captured in the same single system that handles risk management. Because you can link anything to anything else in the system, you can see everything that might be tied to or impacted by the feedback.
We searched for a digital solution to see if one was available after being told that only paper-based systems would satisfy FDA. We found Greenlight Guru and have been delighted with both the product and the service. Greenligh Guru gives us a digital QMS so that we can safely launch our first four products. We feel confident our system can withstand any FDA audits.