QUALITY SYSTEMS
Could you use some extra resources to run your Quality Systems? Do you need to develop your systems in preparation for audits or in response to new business or the changing regulatory environment?
Our highly qualified, experienced personnel can help you with the following processes:
- Complaint Handling
- CAPA
- CE Marking/510Ks
- Regulatory Filings
- Audit Preparation
- Internal Auditing
- Supplier Auditing
- Quality System Development
- Changes to comply with new standards or regulations
- GMP Training
Addressing Audit Non-conformities
If you received significant non-conformities from a regulatory body e.g. a Notified Body, the FDA or an MDSAP Auditing Organisation, our vastly experienced consultants can help you to ensure that you address the audit non-conformities in the most effective possible way
Are you a supplier to the life sciences industry?
Northridge can help you to comply with the following regulations:
- GMPs
- ISO 13485
- US FDA QSR Parts 211 & 820