It'sQA Associates
It'sQA is a quality assurance service provider specializing in clinical research for the life science and healthcare industries. They offer independent, expert GxP audit and consultancy services, with a focus on improving business practices and ensuring compliance with GxP standards. Their mission is to deliver effective, robust QA solutions tailored to client needs, emphasizing independence, continuous improvement, and international reach.
Industries
Nr. of Employees
small (1-50)
It'sQA Associates
Services
Comprehensive audit services for systems, processes and studies in clinical research including audits of clinical sites, vendors, laboratories, pharmacovigilance functions, data integrity, and computerized systems.
Support to establish and manage robust QMS processes and SOPs for the drug development lifecycle to ensure GxP compliance, traceability and inspection readiness.
Recruitment and evaluation services to identify, assess and onboard qualified quality assurance consultants and auditors for GxP roles.
Comprehensive audit services for systems, processes and studies in clinical research including audits of clinical sites, vendors, laboratories, pharmacovigilance functions, data integrity, and computerized systems.
Support to establish and manage robust QMS processes and SOPs for the drug development lifecycle to ensure GxP compliance, traceability and inspection readiness.
Recruitment and evaluation services to identify, assess and onboard qualified quality assurance consultants and auditors for GxP roles.
Expertise Areas
- Clinical trial quality assurance (GCP)
- Regulatory compliance across GxP domains
- Quality management systems for drug development
- Computerized system validation and compliance
Key Technologies
- GxP auditing methodologies
- Quality Management Systems (ISO-based)
- Computerized system validation
- Inspection readiness frameworks