We provide the following quality services:
Quality Management System (QMS) review
We will review your existing QMS and advise what is required to move forward. We can then assist you with any remediation activities or provide ongoing or ad hoc guidance if/when required.
We have expertise in quality systems supporting the development, manufacturing and management of medicines and medical devices.
Specific activities may include:
QMS development and implementation
- QMS planning and support
- Gap analysis
- SOP, form writing and updates
- Risk analysis
- Training support
- CAPA resolution
- Audit readiness support
- Quality agreements
- CE marking support
Auditing
- Independent internal audits
- Qualified Lead Auditor for ISO13485: 2016
- Good Manufacturing Practice (PIC/s GMP) auditing
- Supplier assurance
- Product quality reviews
Batch release support
- SOP/form preparation
- Assess batch documentation
- Assess local shipment documentation