Audit Preparation
Offering supplier audits, assessments, and expert audit preparation for seamless interactions with external vendors, ensuring compliance and quality standards are met.
Supplier Audit
Our comprehensive Supplier Audits meticulously identify potential risks and areas for improvement, fortifying the resilience and efficiency of your supplier network. Whether for initial assessments or in response to specific issues (such as four cause audits), we provide thorough support to enhance your supply chain management.
Data Integrity Assessments & Process Improvements
Our team conducts comprehensive assessments of your processes to identify data integrity risks, refines procedures, and conducts regular quality monitoring assessments. We provide expert guidance and implement corrective actions to ensure secure and reliable operations.
Inspection Readiness and Staff Training for Compliance
We excel in preparing your team for CLIA, CAP, EU, and FDA inspections by identifying process gaps and bolstering compliance measures. Our comprehensive training includes essential do's and don'ts, along with immersive mock inspections and war room simulations to ensure readiness."
Annex 11 and Part 11 Compliance Services
Our team provides support in developing a comprehensive inventory of your computer systems and conducting Good Manufacturing Practices (GMP) assessments to ascertain Annex 11/Part 11 applicability. Through collaborative efforts with your staff, we conduct thorough assessments to identify and address any compliance gaps.