Ensuring data integrity and patient protection in the digital world

Digital Quality Associates are an innovative company offering cutting edge consultancy services to the healthcare industry in four major categories, strategic quality leadership, compliance consultancy, audit/ inspection and training.

A key skillset that resides within DQA is providing its clients with peace of mind that their digital health projects are compliant and inspection ready.

DQA prides itself of being at the pinnacle of the strategic space and offers services to clients that are both innovative and practical in their approach, we aim to simplify and demystify the interface between technology and quality. We offer a service that not only adds value to the business model but can save time and gain efficiencies when submitting regulatory applications for new products.

Matt Jones the principal consultant has over 20 years in the healthcare industry spanning a wide variety of positions and specialties including executive leadership, strategy and technology. He has in-depth knowledge of drug and device development and has worked in some of the largest global healthcare companies in senior positions. He has been exposed to regulators from all regions and has been part of large multi-million-dollar projects.

Service offerings

• Implementation of Enterprise Risk Management
• Quality Risk Management Strategy
• ICH E6 R2 Implementation
• GDPR training and implementation
• Consultancy - introducing digital health businesses
• Risk based monitoring strategy
• Vendor oversight strategy
• Inspection readiness strategy, preparation and hosting
• Post inspection response and remediation
• Audits of complex digital health providers
• EMR audits/ advice/ training
• eGxP audits (eGCP/ eGPV/ eGCLP)
• Strategic audit program design
• GVP program design
• Digital quality training
• Leadership & Auditor coaching
• Blockchain implementation & training

Areas of expertise

Auditing, Audits-CRO, Audits-Company, Audits-For Cause, Audits-Investigator Site, Audits-Phase I-IV, Audits-Process, Audits-Systems, Audits-Vendor, Audits-Vendor Oversight CAPA Management Systems, CRO, CRO/Vendor Qualification and Evaluation, Clinical trial audit plans, Coaching, Compliance Remediation, Data Integrity, Due Diligence, GCP Auditing, Good clinical Practice (GCP), Implementation, Improvement, Inspection Preparation and Readiness, Support and Management, Mock Inspections, Phase 1 facilities, Process, QM Management, QA Systems, Quality Agreements, Quality Management Systems (QMS), Quality Risk Management (QRM), Quality by Design (QbD), Quality Process and Technical Training, Regulatory Inspection-Preparation and Hosting, Regulatory Mock Inspections, Risk Management, Risk-based audit programmes, Training and Development, Vendor Oversight Strategy

Contact Details

Matt Jones

Tel: +44 (0) 7717 495583

Email: info@digital-quality.co.uk

Website: www.digitalqualityassociates.com

Linked in: https://www.linkedin.com/in/matthew-jones-9b6b969/

 

 

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