SoftComply eQMS

The SoftComply eQMS is a Quality Management System (QMS) solution offered by SoftComply. According to the vendor, this customizable eQMS is designed to streamline the development and implementation of regulatory compliant procedures and processes. It is primarily targeted at medical device companies, healthcare organizations, life sciences companies, quality management professionals, and regulatory compliance professionals.

Key Features

Fully Customizable Quality Management System: According to the vendor, the eQMS provides a limited trial view of a Quality Management System (QMS) for Medical Devices, based on ISO 13485, IEC 62304, and 21 CFR 820 standards. It aims to fast-track the development of procedures and processes for regulatory compliance and facilitate the implementation of a full Quality System.

Embedded Guidance for Customizing Your QMS: The vendor states that SoftComply eQMS includes a complete "Example QMS" based on real industry cases. It offers info-boxes, warnings, and notes that suggest best practices for utilizing the Quality System effectively. This embedded guidance assists users in customizing their QMS to meet their specific needs.

Compliant QMS Documentation: According to the vendor, the eQMS is compliant with ISO 13485, IEC 62304, FDA 21CFR 820, and TGA standards. It provides essential documentation, including a Quality Manual, Quality Policy, 25 Standard Operating Procedures (SOPs), and 77 pre-filled templates. This feature aims to expedite the implementation of a Quality Management System for medical device companies and offers full customization options with guidance for finalizing the documents.

Cloud eQMS Solution: The vendor claims that SoftComply eQMS can be extended to create an FDA and MDR compliant Cloud eQMS Solution. By leveraging existing Confluence apps and SoftComply's services, it offers compliant document workflows and e-signatures. This cloud-based solution provides organizations with a fully customizable platform for managing a compliant Quality System.

Automated Confluence Integrity Checks: Integration with the Validation app for Confluence Cloud allows for regular integrity checks of Confluence content. According to the vendor, this feature helps ensure the accuracy and reliability of the QMS documentation by detecting any potential issues or inconsistencies.