Audits can be large and resource-heavy activities due to the scope of examining the entire quality system periodically. Quality managers can feel tremendous stress if there are gaps in their data and quality processes. Being unprepared for an audit, whether internal or external, can lead to fines, penalties, or worse product recalls.
Qualio’s cloud-based quality management system gives your team the tools to be 100% audit-ready at any time. Easily provide all artifacts needed for an audit, prove compliance, demonstrate continuous improvement, and report on the status of any findings. With Qualio, audits are faster and no longer stressful.
Pre-configured templates and pre-written documentation for FDA & ISO compliance.
Access to our team of quality experts to ensure you meet and exceed your QA goals.
With Qualio’s secure and cloud-based system, paper files, folders, and spreadsheets become a thing of the past.
Qualio’s Design Control accelerates medical device product development by uniting your systems and data in one place.
Prevent potential risks early and mitigate risk easily with easy risk management that complies with ISO 13485 and ISO 14971.
Create assessments, assign, report, and track training activity across your company within one platform.
Qualio’s change control software allows you to manage any change easily and effectively, ensuring compliance and audit readiness.
With Qualio Events, manage pre-defined actions and responses and track in accordance with regulatory requirements.