Quality Assurance Audits
Quality Assurance (QA) Audits should be performed as an essential management tool to verify quality system conformance to established requirements, ensure that quality systems have been successfully implemented, provide objective evidence in the effectiveness of achieving defined goals, and result in the reduction and/or elimination of nonconforming areas.
BioTechLogic has experienced auditors to perform QA audits in accordance with global regulatory requirements. Our experience allows us to provide you with additional resources and expertise to conduct QA audits and support an independent assessment of your quality system.
Examples of our QA Audit Services:
- Gap Assessment Audits - An audit of the current quality system to ensure compliance with applicable regulatory requirements, which is typically performed prior to the implementation of the quality system or upgrading the quality system to a new requirement.
- Full or Partial Internal Audits - An on-site audit of the full quality system or a partial audit to assess specific processes in the quality system.
- Subcontractor / Supplier Audit - On-site subcontractor/supplier audit to ensure on your behalf that contracted services are executed and maintained in accordance with your specifications and regulatory requirements.