Inspection Readiness Assessments and Remediation
The first step in establishing a state of effective inspection readiness is to understand where you stand today and where your greatest areas of risk exist. Our global network of seasoned professionals will review your current procedures, outputs, tools, staff and programs. Each TriRadial team member has a minimum of 20 years’ experience interacting with and responding to Health Authority officials. After assessing your areas of risk, we can help you to develop clear corrective action plans to address areas of weakness with minimal disruption to your day-to-day business.
Learn how an emerging biopharma company and a company going thru their first Pre-Approval Inspection (PAI) approached their inspection readiness assessments
Inspection Readiness Training
Your team members understand their roles and they are experts in the science. We can help them understand the inspection process, be better communicators with investigators, and to be more organized during an inspection. We will provide practice scenarios and customized role-play to get them up to speed and build confidence. We will also help you to design and organize an efficient backroom operation so that you can get appropriate evidence to HA investigators in a timely and organized manner.
View how TriRadial helped an emerging biopharma train their team across all GxP's to be prepared for their upcoming inspection
Key Performance Indicators and Dashboarding
As they say, you cannot manage what you cannot measure. Our team has an extensive set of Key Performance Indicators (KPIs) with defined thresholds for action that span all the main areas of your operation. These KPIs allow leaders to have a direct line of sight into operational performance and enable them to manage by exception. With links to your operational systems, the dashboards can be dynamic, drillable and span all key areas of your organization.
Click to download a sample of some of our inspection readiness dashboards.
Inspection Management and Quality Staffing
Your programs are advancing quickly. Your quality infrastructure has not kept pace with your growth. You need short-term, high-quality expertise in place who has been through Health Authority inspections in the past. Sometimes your need to fill key roles outpaces your ability to find the right people. TriRadial has a global network of quality experts with decades of experience, who can quickly step in and bridge the gap until you can fill the roles internally.