Six steps to a compliant pharmacovigilance audit strategy. Arriello’s Auditing and Quality Assurance Manager Kamila Erbanova has created a new in-depth and practical audit strategy guide that should help your PV QA team keep pace with regulatory requirements as product portfolios, supply chains, and PV risk landscapes evolve.
When things go wrong, too often companies apply a temporary fix and move on. A better, quality-focused approach is to find out exactly what caused the issue and learn from that.This is where optimizing Corrective Action Preventive Action (CAPA) processes is key. This eBook sets out a best practice approach to successful CAPA management.
Helen Lowe at Arriello outlines a best-practice approach to deviation and CAPA management, highlighting the importance of looking at systemic failures in progress, uncovering root problems, building solutions, and reviewing preventative measures to ensure the long-term benefit of the company.
Errors sometimes occur during drug development, but if pharma companies apply only a temporary solution to the problem, they risk repeating the same mistakes. Helen Lowe at Arriello outlines a best-practice approach that ensures the errors of the past are not repeated.
Our auditing solutions: Consistent, independent and flexible.
Our Quality operation is headed up by highly-experienced Quality and PV experts, who are also trained auditors. We also have a substantial global network we can draw on for additional specialist resource, allowing us to scale activities efficiently for larger requirements.
Helen joins Arriello to further strengthen client-side operations and procedures, and develop key new Auditing and QA services to add to our portfolio.
Remote audits — some key advantages. Before you shift to remote auditing, you’ll need to review all processes and procedures to ensure they adapt fully to the remote model.
Writing for IPI Media World Arriello’s Vanessa Fachada Oliveira on why so many Pharma companies are failing their regulatory audits
Many life sciences companies are still struggling with pharmacovigilance audits and inspections. Arriello’s Vanessa Fachada Oliveira highlights key areas of focus for MAHs to achieve an effective audit of their PV systems.