GxP Issue Resolution for Compliance and Quality Assurance.
Timely support for all GxP challenges.
Performance of activities Right First Time is one pillar of GxP compliance, but we know that invariably things may go wrong at some point. A proactive and informed process for handling issues related to GxP compliance is essential to ensuring an appropriate response that assures product quality and patient safety. Our consultants have the expertise required to navigate and resolve GxP compliance issues, not only providing strategic advice but also, when necessary, providing an extra pair of hands, working with the relevant teams to meet deadlines.
Manufacturing challenges that impact contamination control or sterility assurance require immediate investigation and the support of an experienced and objective partner can speed up the reaction time, improve decision making and get the manufacturing schedule back on track whilst improving the quality of investigations and resulting CAPA actions.
Audits and Inspections invariably lead to observations and whilst good planning and preparation may reduce the severity and number of observations, objective support may be useful in the response to and remediation of observations.
Our experienced consultants can impart pragmatic advice, provide industry benchmarking and support the collation of the most appropriate observation responses.
What our clients say about us.
After evaluating several vendors to help us set up and manage our global literature screening process, we chose Arriello due to their professionalism and thorough understanding of global requirements.
Arriello has highly knowledgeable staff in all countries with a very professional attitude. They are very fast in responding when needed.
