No two clients are the same so all aspects of the services that Digital Quality Associates offers is tailored to the needs of the client. Don’t hesitate to contact us if the specific support you are looking for is not listed below. In addition, we now offer most of our services remotely if required.
Our detailed audit reports will provide a clear explanation of audit findings, their relevance and importance as well as recommendations moving forward.
- Implementation of Enterprise Risk Management
- Quality Risk Management Systems
- Audits of complex digital health providers
- GxP audits (GCP, GVP, GLP, GCLP, GMP, GDP, CSV)
- eGxP audits (eGCP/ eGPV/ eGCLP)
- EMR audits
- Audit services encompassing all healthcare & management system standards (including ISO 9001, 13485, 14155, 27001, 64035, 31000)
- Investigator facility audits
- Vendor audits
- Process & system audits
- Document audits
- Remote auditing
- Strategic audit program design
- QMS development
- Strategic audit program design, set up & management
- GVP program design
- Due Diligence
- SOP development, review & implementation
- Gap Analysis
- Introducing digital health businesses
- Vendor oversight strategy
- ISO Consultancy including ISO 9001, 13485, 14155, 27001, 64035, 31000
- EMR advice
- Risk based monitoring strategy
- Medical Devices
- Provide regulatory advice (including ISO 9001, 13485, 14155, 27001, 64035, 31000)
- Ensure regulatory compliance in the most challenging situations, proposing implementable solutions, which are scalable to all situations
- Reducing regulatory risk
- Inspection readiness strategy, preparation and hosting
- Post inspection response and remediation
The value of training to a client comes from being able to tailor the training to meet client’s own internal requirements. This is why we provide bespoke training for clients which can be run remotely or in person events.
In addition to the areas covered in Auditing, Consultancy & Regulation above, we can also offer:
- Digital quality training
- Blockchain implementation & training
- Leadership & Auditor coaching
- EMR Training
The list is not exhaustive by any means so if you have something in mind, please get in touch and ask.