QFacts and the Shift From Manual Quality Management to Intelligent eQMS

Overview: How Qfacts’ AI‑Driven eQMS Platform Transforms Medtech Device Quality Management

Qfacts is a cloud-based eQMS platform that digitises and connects core quality management processes for regulated healthcare and life sciences organisations. It centralises document control, change management and CAPA activities in a single environment, helping teams move away from fragmented spreadsheets, email-driven workflows and manual tracking that slow decision-making and increase compliance risk. With standardised, preconfigured workflows based on quality management best practice, you reduce the effort to implement and maintain consistent processes across teams and sites.

In this directory, eQMS tools are assessed on whether risk information simply documents issues after they occur or actively drives CAPA, change control, complaints and management review from a central risk model.

The platform uses structured data capture, configurable workflows and automated timelines to create a real-time, auditable record of quality events and actions. This supports more reliable oversight of investigations, training status and document revisions, while giving operations and quality leaders better visibility into emerging issues and bottlenecks. For healthcare and MedTech organisations, the result can be shorter cycle times for change control and CAPA, fewer manual hand-offs, and improved confidence that quality information is complete and up to date when supporting audits or strategic decisions.

What is Qfacts?

Qfacts is an electronic quality management system (eQMS) platform that digitalises core quality processes such as document control, change control and CAPA for regulated healthcare and life sciences organisations. It is primarily used by MedTech and pharma manufacturers, quality and regulatory teams, and other regulated operations that need a centralised environment for managing quality records. Qfacts is differentiated by its focus on structured, audit-ready workflows aligned with industry quality standards, supporting consistent, traceable execution of quality activities across teams and sites.

Why Leading Healthcare Teams Trust Qfacts

• Designed to support compliance with FDA 21 CFR Part 11, GxP and GAMP 5, indicating alignment with key global regulatory frameworks for pharma and life sciences quality systems.

• Presented as a plug-and-play, GAMP-validated platform, reducing the validation burden for regulated organisations adopting the system.

• Provides audit-ready records with detailed timelines for each quality event, supporting transparent traceability during inspections and internal audits.

• Markets itself specifically to pharma, biotech and other regulated industries, signalling a product focus on high-compliance environments rather than general-purpose document management.

• Emphasises standardised workflows for document control, training, change management and CAPA designed around regulatory expectations, which can lower the risk of process deviations.

• Operates as a cloud-based platform with centralised data, enabling controlled access and consistent quality records across teams and sites.

• Publicly positions quality and compliance as core to its value proposition, providing regulatory-focused materials that help buyers assess fit against their own quality system requirements.