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”
