Services
Qualidea provides the following services:
Audits
GCP: Every phase of a clinical trial: clinical trial protocol, laboratories, clinical investigator sites/institutions, pharmacies, statistics, data management, clinical trial report
GLP: Every phase of a preclinical trial: protocol, laboratories, test facilities, test sites, statistics, data management, preclinical study report
GMP, Medical devices, ISO 9001 and ISO 13485: Quality systems
Audits of your Quality systems
Audits of your subcontractors/vendors
Standardized Operating Procedures
- Training of principles, reviews, writing and management
- Reviews of existing procedures and practices
- Writing of your SOPs
Quality Consultancies
- Discussions with the management, guidance in quality and QA processes
- Supporting in quality thinking and implementation of
- Continuous improvement
- CAPA processes
- Change management
- Risk management
- Business continuity
- When building a Quality Management System, evaluations of the quality needs of the company
- Evaluations of existent Quality Management Systems
- simplifying of your quality systems and quality documentation
- Inspection readiness audits and evaluations
- Ongoing support in your quality practices
Training of the personnel
- Tailored training with practical examples and discussions
Assistance in your projects other than QA/Quality function
Sometimes you might have situations where you need additional short-term help outside the quality function. Qualidea could help in e.g., reviewing/organizing your documentation.