Most client companies have a quality team on staff as, traditionally, it has proved culturally awkward to import assistance from the outside.
The difference with The CQA Company™ is that clients are able to access a live QA function rather than a theoretical consultancy. In effect, clients “borrow” fully operational personnel with the flexibility they would expect from their own staff. The TCTC Group operates its sister company The CRA Company™ in the same way. Staff demonstrate a wide understanding as a result of experience gained working with a wide range of clients in a variety of sectors.
The following services are available on a pick and choose basis:
- Quality Management System preparation and development.
- Statutory GCP and GMP preparation, mock inspection and Inspection management
- Internal and external audits (GCP,GLP, GMP and Annex 13)
- Review of quality systems and legacy operations
- Process Mapping
- Working procedure evaluations
- Documentation management
- Quality staff training
- Serious GCP breach investigation and reporting.
- EMEA Inspection preparation and management
- FDA Pre Approval Inspection preparation and management
- QA Helpdesk service through TCTC “Advice on Line”
