It can be difficult in a paper-based or segmented quality system to know the downstream impacts of any change. As a result, change control can halt your product development process, and audits of your quality system may result in findings or complications with suppliers.
Qualio streamlines Change Control by providing actionable insight on changes made across quality artifacts - from Documents and Templates to Design Controls. We enable end-to-end traceability and auditability for every change, ensuring your team is compliant and building a safe and effective product.
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.
Seamlessly generate reports on activity across your system and your users and set periodic review cadences.
With Qualio Events, manage pre-defined actions and responses and track in accordance with regulatory requirements.