GXP Systems

Auditing Our team will make your team audit ready with our right sized approach

Audit

With an impending audit, you can rest assured that Stericycle GxP Solutions will deliver expert auditing services and our team will make your team audit-ready. 

We specialize in multi-site and global supplier audits and can also audit your programs and strategies, followed by implementation and execution of required activities to address FDA 483s, warning letters and consent decrees

Where can we audit?
  • Multi-site audit programs
  • Global supplier audit programs to evaluate compliance of your suppliers against FDA standards
  • Contract Manufacturing Organization (CMO) audit makes sure your outsourced manufacturers’ procedures are consistent with regulatory requirements
  • Internal quality auditing provides unbiased and independent report, highlighting all relevant issues
  • Periodic review to assess and report on the performance and validated state of all your systems and equipment
  • Risk assessment using a wide range of techniques including FMEA and PFMEA to identify and quantify the appropriate level of validation
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What can we audit against?
  • GMP, GLP, GCP program auditing
  • Policy and procedure review against all current GMPs ensures compliance with all relevant regulatory standards
  • Software quality assurance/practices to report on processes and methods used by all key software project stakeholders
  • NDA, 510(k) and CMC compliance ensures all your new and existing products comply with all applicable regulations
  • 21 CFR Part 11 & Annex 11 compliance that creates, maintains and supports controls to ensure data authenticity and integrity
  • Pre-UAT, pre-go live readiness audit and post go-live audit services ensures your readiness to begin an operation

Interested in our solutions?

Contact us now.