PV Audits & Self-Inspections

Count on us to meet all of your auditing needs

Get Ready For Your Next Health Canada GVP Inspection through both remote and on-site audits.

Set-Up A Complaint
PV SYSTEM

Before your Audit

Preparation is everything and planning ahead is key. At Zenith, we develop an annual audit calendar and work with your team proactively to close out past audit observations, conduct periodic PV Self-inspection for internal company readiness in preparation for Health Canada PV inspection. We provide clearly identified next steps and help develop a learning mindset to audit readiness.

During your Audit

We provide on site support to your team during a Health Canada PV audit. This includes managing the agenda, liaising with the HC auditor, addressing questions and answers and close out the audit successfully.

After your Audit

Our job is not complete until the audit observations and next steps and actions are identified, and an implementation plan is developed. We ensure a system is in place for timely Corrective Action and Preventative Action (CAPA)

Extend your readiness by auditing your vendor partners

Auditing and risk benchmarking of marketing partners/distributors/ service providers/ vendors not previously audited is an often-overlooked key area. We will help you be prepared by being comprehensive in your approach to auditing.

ASSESS YOUR PV AUDIT READINESS IN 2 MINUTES OR LESS

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.

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)

Through a diligent planning and inspection process, we ensure you have a strong functional PV system that is compliant with Health Canada GVP guidelines and help you achieve a Compliant Rating.

Download our Guide to PV Audit Success