Building a QMS for the first time
You lack the conceptual expertise or hands-on experience to develop and implement an efficient, GxP-compliant QMS.
Quality Assurance
QMS Development & Optimization
Build, modernize or remediate a quality system that works in practice
Whether you are building a quality management system from scratch or improving one that no longer fits your organization, QbD Group supports GxP-regulated pharma, biotech and MedTech companies with practical QMS/PQS development, implementation and remediation, designed around your actual processes and responsibilities.
The essentials
What is QMS implementation and remediation?
A quality management system (QMS), or pharmaceutical quality system (PQS), is the framework of policies, processes, responsibilities and records that ensures the quality and safety of your products and your compliance with regulatory requirements. QMS implementation covers developing and rolling out that framework: from policies and procedures to QMS software and personnel training. QMS remediation covers assessing an existing system, identifying gaps and modernization priorities, and bringing it back to an efficient, compliant state.
Frameworks we work with
- GMP and PQS (ICH Q10)
- GDP
- GCP
- ISO 13485:2016
- FDA 21 CFR Part 820 (QMSR)
- EU MDR and IVDR
- MDSAP
Common scenarios
When do companies need support?
A system that no longer fits
Fragmented processes, unclear responsibilities or outdated documentation make your QMS harder to run and harder to defend.
Regulatory change
New or revised requirements, such as the FDA's QMSR, call for a maturity assessment and clear modernization priorities.
An independent view
You need an external party to advise on how to improve or remediate your QMS, and whether it is ready for a regulatory inspection.
Our services
How we help
QMS development & implementation
- Drafting of policies, procedures and work instructions based on industry good practice templates
- Selection and implementation of suitable QMS software
- Awareness training for management and training of personnel
- Project management for the QMS roll-out
Available as full-service implementation, coaching and support on your own documentation, or startup assistance to help your team plan its first QMS.
QMS remediation & improvement
- QMS/PQS maturity and efficiency assessments
- Identification of gaps and modernization priorities
- Remediation of system-level gaps identified in audits, inspections or self-assessments
- Simplification of fragmented processes and outdated documentation
- Continuous improvement embedded in your daily operations
QMSR compliance for medical devices and IVD
Align your quality system with the FDA's Quality Management System Regulation.
Medical devices & IVD
QMSR compliance
Align your quality system with the FDA's new rule and stay inspection-ready in the US market.
The FDA's Quality Management System Regulation (QMSR) replaced 21 CFR Part 820 and now incorporates ISO 13485:2016 by reference, with FDA-specific requirements layered on top.
QbD Group helps medical device and IVD manufacturers assess their system, close the gaps and stay inspection-ready, whether already ISO 13485 certified or building toward US market entry for the first time.
Get QMSR-ready
Four steps
Our process
- 1
Assessment
We analyze your current processes, documentation and QMS maturity, and identify gaps and priorities.
- 2
Design
In workshops with your stakeholders, we define requirements and design a practical solution based on your actual processes and responsibilities.
- 3
Documentation & implementation
We develop or update procedures, policies and work instructions, and support the selection and roll-out of QMS software.
- 4
Training & continuous improvement
We train your teams to adopt and maintain the QMS, and embed improvement practices that keep it efficient and compliant.
Why QbD Group
Your trusted QMS partner
With a 20+ year track record as a QMS partner, QbD Group is a preferred supplier for Top 20 Pharma and MedTech companies.
Partner with usPractical QMS design
Systems designed around your actual processes and responsibilities, not generic templates.
Broad range of QMS capabilities
Expertise covering organization, processes, facilities, utilities, IT and equipment.
Cross-disciplinary expertise
QA expertise combined with other QbD Group specialists, such as regulatory, validation and software, where the scope requires it.
Global pool, local presence
QMS experts worldwide with local on-site support capabilities, and remote delivery where it makes sense.
EU and US frameworks
A proven track record across ISO 13485:2016 and FDA 21 CFR Part 820, bridging your EU and US quality systems.
Let's talk Quality Assurance
Whether you need QMS setup, audits, or ongoing compliance support, our QA experts are ready to help.