Quality Audits
Quality Audits
Quality assurance consulting assesses a company’s processes, procedures, and products to ensure compliance with the latest industry standards and regulatory requirements. Audits can be used to verify compliance with regulatory requirements, identify gaps in the quality system, and prepare for FDA or sponsor inspection or reviews. Identifying gaps in the quality system and fixing them pre-inspection may prevent having to investigate and report on inspection findings. Common audits provided by QualMedica include:
- Investigator site audits
- IRB directed safety audits
- Vendor audits
- Document reviews
- Inspection readiness and mock inspections