Consulting

As one of the leading providers of Pharmaceutical Regulatory Affairs & Pharmacovigilance services, one of the areas we have developed deep experience in is auditing, both as the auditee and the auditor (as part of our Vendor Management System). 

Our Auditing Experience

We are audited numerous times each year as part of the audit trail from our clients as they themselves either prepare to be audited or, as part of a health agency inspection, where we are part of the system they maintain.  Moreover, we are inspected by Health Agencies for our Pharmacovigiulance system.  This gives us a unique angle to understand what is required in order to be compliant.  As part of our ISO9001 Quality Management System, continual improvement is integral to our thinking, so when we get audited, we learn from it and make improvements, no matter how small they may be.

AIR™ - Audit and Inspection Readiness

Our offer is that we can provide auditing services across a number of different areas.  We can provide different levels of audit support based on your requiremements and all audits are tailored to your understanding and needs.  These are as follows:

Pharmacovigilance

  • GVP -  Preparing you for a Good Pharmacovigilance Practice Audit (as per the guidance here) including:
    • Preparation for a Health Inspection Audit
    • Auditing your existing system and looking for Arriello Best Practice improvements
    • Training and advise on how to audit your internal teams (including local affiliates/vendors)
    • Assistance during inspections

Quality Management System

  • Development and Review of Quality Management Documentation (SOPs. Work Instructions, Processes)
  • Consultancy (Quality Management System Implementation based on ISO 9001:2015, introduction to the ISO)
  • Document control, record management and record retention processes
  • CAPA and deviation management Training
  • Development of Quality review processes (QC/QA)
  • Creating metrics to measure performance of QMS and quality objectives
  • Reviewing and preparing best practice for contracts with partners, affiliates and vendors

Manufacturing

  • GMP – Preparing you for a Good Manufacturing Practice Audit:
    • Globally
    • Including auditing your API source

Distribution

  • GDP – Preparing you for a Good Distribution Practice Audit

Clinical Supplier Audits

  • GCP – Preparing you for a Good Clinical Practice Audit