Participate in our Survey

This brief survey is designed to assess your company’s PV audit readiness using a simple set of questions. These questions are based on common audit shortcomings we have observed. At the end of the survey, please indicate if you want to free, confidential discussion with a senior Zenith partner.

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ASSESS YOUR PV AUDIT READINESS IN 2 MINUTES OR LESS

Step 1 of 5

First Name(Required)

Last Name(Required)

Email Address(Required)

Company(Required)

How confident are you about your PV quality management system?(Required)

(Please consider your current procedures for managing deviations; external service partners qualification; challenges in identifying and implementing corrective/preventative actions (CAPAs); and oversight/compliance management of PV service provider)

How robust is your PV training and associated documentation?(Required)

Do you have clear, up-to-date PV agreement with all parties handling your PV functions and with respective PV responsibilities of each party?(Required)

In your last audit, were there are any Risk management-related findings related to poor maintenance of product safety monitoring or any request to implement additional risk minimisation measures, such as educational materials or pregnancy follow-up procedure?(Required)

Inconsistent or inadequate record keeping is a common audit finding, even when there are clear SOPs. How important is it for you to have a properly validated safety database for ICSR management?(Required)

How confident are you in meeting the exact HC guidance on benefit-risk assessment, signal detection and aggregate reports (ASRs)? Common issues include failure to include relevant cases in the benefit-risk assessment and inadequate critical analysis in ASRs resulting in delayed product information update.(Required)

Are you concerned about poor integration/interfaces between departments or with external parties to support complete and timely safety information?(Required)

Do you have appropriate systems to ensure safe archiving/backups and a supporting business continuity plan?(Required)

Participate in our Survey

GETStarted

ASSESS YOUR PV AUDIT READINESS IN 2 MINUTES OR LESS

Call A Zenith Partner Today For A Discussion Or A Demo Of Our Capabilities