When a company plans to establish or is establishing a quality system and the quality management department, maybe they don’t have sufficient experience or manpower to manage the relevant quality activities. Or when products are in the early clinical stage, maybe the quality activities appear volatility and the overall workload is not so high, it may be costly to have a quality team in place. gempex can provide QA related services to support the customer in managing and executing the related responsibilities and tasks until the customers can carry out the activities independently after having the sufficient resources.
1. Maintain and manage the new established quality management system
2. Prepare training plan and implement training
3. Execute internal audits
4. Provide supplier management (audit execution for suppliers)
5. Provide orreview quality agreements
6. Review records related to system operation (changes, deviations, batch records, etc.)
7. GMP compliance support for the routine activities
8. Update GMP regulatory
9. Provide training and compliance support
