MediaLab's Intelligent Quality Engine (IQE) solution is designed to deliver powerful automation for laboratory non-conforming event management processes and complaint resolution. IQE eliminates the need for paper-based, manual investigation and CAPA processes, while reducing cost and supporting the quality improvement program. IQE helps your laboratory follow corrective and preventive action standards as outlined by CAP, FDA, Joint Commission, ISO, and other accrediting bodies. You'll benefit from a streamlined approach that supports your regulatory compliance.
The Most Comprehensive and Targeted Solution for LDTs and Complaint Resolution
Leverage the expertise of the #1 lab compliance software company in the country that is developing a customized, comprehensive LDT solution to meet your needs.
With the FDA's upcoming changes for laboratory developed tests (LDTs), having a consistent, complete, and accountable system for handling complaints and non-conforming events is more important than ever. Trace your investigation through corrective action, preventative action, and reportability criteria. Collect signatures from stakeholders and accountable decision makers. All activity is logged, timestamped, and protected with 21 CFR Part 11 compliant electronic signatures. IQE's powerful reports and dashboards give your laboratory unsurpassed visibility on all complaints and non-conforming events, so you can stay ahead of quality issues and report as needed.
If a complaint or non-conforming event involves an LDT and becomes reportable, IQE can prepare an eMDR and track your submission directly to FDA.
Learn more about on LDTs and MediaLab’s development plan to help all clients meet the requirements of all five of the FDA’s stages of LDTs
Manage NCEs / CAPAs Through Their Whole Lifecycle
Start by using our online form templates, or create your own. Allow employees to create events as problems arise. MediaLab will route your event through each phase of the event management lifecycle, from initial event description to risk analysis, closure, and change effectiveness evaluations.
All CAPA events follow a lifecycle, from description and risk assessment, to investigation, corrective & preventive action, and evaluation of effectiveness. Each phase asks appropriate, customizable questions to collect necessary information.
Use the Five-Whys tool to help get at the root cause of the problem. List causes of the event and ask “why?” as many times as needed to dig down to the source of the issue, and then generate remediation actions to address the root cause.
IQE's collaboration tools make it easy to get feedback from other parties who were involved in an event or whose feedback is needed. Request collaboration from any user in MediaLab or outside users as well. Collaborate on completing the form by letting these users fill in appropriate fields, while preventing them from changing sections that they shouldn't.
Event owners are responsible for guiding non-conforming events through the CAPA lifecycle of description, risk assessment, investigation, corrective & preventive action, and evaluation of effectiveness. They can request collaboration and feedback from other users, allowing everyone to contribute to continuous quality improvement.
Get 21 CFR Part 11 compliant electronic signatures on your event. You can request signatures at any point in the CAPA lifecycle and from any user.
Your Forms, Made Better
Your current processes and forms work beautifully in IQE. We'll show you how to create your own custom forms (non-conforming event, change control, failed PT investigations, and more) using our flexible form builder. Customize workflows, collaborations, approval requests, and reports. Take spreadsheets out of the picture and start enjoying the power of automation.
No need for paper-based event forms, manual collaboration processes, or spreadsheets managing your nonconforming event data. Increase your CAPA productivity using our centralized online system. Upload supporting documentation directly into IQE. Collect feedback from employees and administrators right from your forms. Assign and collect 21 CFR Part 11 compliant approval and evaluation electronic signatures.
One central, organized to-do list provides a hub for all the activities that your users need to complete in IQE. No hunting for the right event or getting lost in the shuffle.
Reminders and notifications are sent to your users automatically, so they stay on top of what they need to do to properly close out events. Customize how frequently your users get notifications and reminders from IQE.
IQE keeps track of every event view and every change. You have a full audit trail of all user activity to see exactly how your users are interacting with your events.
IQE comes with several out-of-the-box reports for our template forms, but you have full control to customize and save your reports to see exactly the data you need. Automatically include summary tables, charts, and graphs of your data. Filter and drill-down into data by multiple dimensions to isolate trends and problems.
See how your forms change over time. As modifications are needed, MediaLab automatically keeps track of previous versions of the form, so you can see the form just as it was when your users filled out events. Users work from forms that have been approved by your lab director, quality managers, or other key personnel.
Intelligent Access Control
You can assign roles to individual users or to groups of users based on title, job description, or laboratory function. Users can see only what's need for their role. Get collaboration from other users without revealing all details of the event or follow-up.
Select users who can create and edit forms, who can start events for which forms, and who can own events for which forms. Limit administrative access to just a handful of users, or let each department supervisor manage their own non-conforming events.
Let all your users have some access to IQE. They can start reporting on events that they encounter and provide the initial description. Events are then handed off to event owners, who complete the CAPA lifecycle for each event.
All events have an owner that's responsible for making sure the CAPA lifecycle gets complete. Owners are reminded whenever an event stalls that their attention is needed to remedy the situation.
All your laboratory employees can take advantage of IQE's online forms to start recording events and provide initial description. These events are then handed off to owners (quality personnel, supervisors) for further progress through the CAPA lifecycle. Details are then hidden from your regular users, unless they have specific permissions to view events.
Powerful Reporting for Tracking and Trending
Tracking and trending has never been easier. IQE's robust reporting and data engine allows you to control your event statuses, tracking/trending reports, dashboards, event retrieval, and more. Use standard reports or filter by user-defined criteria. View all events by type, location, date, and more. Your data is viewable in real-time, all the time. Export your data into PDF, PowerPoint and Excel reports for quality committee presentations.
IQE's intelligent dashboards and reporting helps you locate errors quickly and work to a resolution that prevents reoccurrences. Dashboards highlight how your non-conforming events are moving through the CAPA lifecycle of description, investigation, corrective & preventive action, and reporting.
IQE can generate PDF copies of your forms and events for archival purposes, as well as PDF copies of your reports that can be downloaded to your computer or saved within IQE for future review. IQE also exports Excel spreadsheets of your reports, so you can do additional reporting and searching in Excel.
A Key Part of Risk Management
Repeated non-conforming events and their subsequent investigation and mitigation cause avoidable risks and takes up time, especially without an automated system in place. IQE will help your laboratory monitor your important metrics with our real-time reports and dashboards. Follow-up tasks are scheduled, employees are notified, and processes are made efficient.
Integrated Across the MediaLab Quality Management Platform
Integrated into MediaLab's platform of quality software, IQE connects with our Document Control, InspectionProof, and Compliance & CE systems. Easily annotate changes to SOPs and policies and provide training updates to lab team members to fulfill change control requirements.
