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SharePoint Quality Management System for Medical devices

Compliance with the ISO 13485 standard is essential for medical device manufacturers in order to provide medical devices and related services that consistently meet the customer and regulatory requirements.

SharePoint is a proven solution for managing your next ISO 13485 medical device document control system to ensure compliance.

Modules available

Electronic document management system

Ibiqs can quickly configure your existing SharePoint so that it compliantly houses and controls your critical business and quality documents in a secure cloud environment or server at your site.

Corrective and preventive actions (CAPA)

Our CAPA module provides a way to efficiently manage your CAPA documentation so you can stay on top of issues and view metrics on your CAPA process efficiency.

 

Deviations and non-conformances

This module can capture all the detail surrounding issues such as process failures, exception events, adverse events and even site incidents as well as track any recurring trends so you can be make proactive decisions.

Supplier management

Suppliers, can be easily managed and integrated into your audit program. Any documentation collected during the audit process is available for the supplier, as well as any associated deviations or non-conformances. 

Audits

The audit module provides you a way to manage both internal and external supplier audits. You can control the initial audit planning and scheduling all the way through to the final reporting.

Change control

Our change control module allows you to track and manage the creation, approval and associated actions of critical changes required by  your systems and processes.

Customer complaints

The customer complaint module enables you to efficiently manage your customer complaints - an important factor in regulated industries where patient safety is the number one priority.