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ISO 13485 Software

Paradigm 3 Compliance and Document Control software provides a complete integrated package for management of your quality and regulatory systems to meet the complex requirements of ISO 13845/GMP 820. With Paradigm 3, numerous tools assist in meeting and managing these requirements.

Targeted action items are delivered via email and are accessible through a personalized dashboard, ensuring that tasks are carried out on time. In addition, the Paradigm 3 software provides transparent accountability throughout your quality system.

These action items provide seamless workflows for such tasks as review, approval and release of documents, and, managing CAPA issues from corrective actions, customer complaints and/or nonconformance - from instigation through root cause, to implementation and completion. Our system also comes with complete validation scripts and meets all requirements of CFR part 11.

Paradigm 3 is comprised of several integrated modules, available to purchase individually or as a group, including:

  • Document Control
  • Training
  • Design control
  • Audit Management
  • Corrective/Preventive Action
  • Customer Complaints
  • Calibrations
  • Equipment Maintenance
  • Approved Vendors

These integrated modules, along with advice from our expert staff, enable you to effortlessly achieve and maintain registration of your quality system.

Paradigm 3 ISO 13485 software provides the tools to ensure quality system compliance. Moreover, Paradigm 3 software delivers a flexible and customizable package to suit your organization’s specific needs.

To experience the advantages of Paradigm 3 Compliance and Document Control software, request a free online demo.