Off-the-Shelf DHT Quality Management System

Partner with qointa for Confidence in Compliance

With qointa, you’re not just buying a service — you’re gaining a global compliance partner. We help you reduce risk, accelerate timelines, and protect the integrity of your trial data.

→ Get Started with the OTS DHT-QMS

Accelerate Compliance with an Audit-Ready DHT-QMS

Get a preconfigured, regulatory-aligned Quality Management System to launch or scale your decentralized and hybrid trials quickly and confidently.

 

The Challenge

Digital Health Technologies (DHTs) enable modern, decentralized research—but they also demand validated processes, documentation control, and audit-ready oversight.
Building a compliant Quality Management System from scratch is resource-intensive and time-consuming.

Our Solution

qointa’s Off-the-Shelf DHT-QMS provides a ready-to-deploy framework built on ISO 13485, FDA 21 CFR Part 820, and EU MDR principles.
It equips sponsors, CROs, and MedTech partners with instant, regulator-aligned operational control.

What’s included:

  • Standardized QMS templates and SOP libraries for DHT management

  • Prevalidated document control, training, and CAPA workflows

  • Integrated risk and change-control tracking

  • Optional connection to existing eQMS or sponsor systems

Benefits:

  • Immediate audit readiness

  • Reduced setup time and cost

  • Consistent documentation across studies and vendors

  • Scalable for global operations

How It Works

  1. Assess — Quick review of your current documentation and compliance scope

  2. Configure — Tailor the OTS QMS modules to your study or enterprise needs

  3. Deploy — Implement workflows, training, and records within weeks

  4. Support — Ongoing updates, monitoring, and inspection support