QUALITY AUDIT ON THE IT SUPPLIER OF A PHARMACEUTICAL GROUP 

PROJECT DETAILS

CONTEXT OF THE CUSTOMER

The customer needed to make an audit on one of its IT subcontractor. The audit had to be made in only a month and remotely because of the lockdown regulations.

In addition, the pharmaceutical industry has strict regulations concerning data management.

The audit had to make sure the subcontractor was compliant. It reviewed the subcontractor’s organization, quality units and systems, documents and change controls, CAPA management, IT infrastructure, maintenance and cyber security.

NALYS SOLUTION

Phases of the project:

• Discussing with the client to determine the needs for the audit

• Establishing a questionnaire and audit checklist

• Validate it with the client following its strict audit processes 

• Send the questionnaire to the supplier

• Review the items that needed clarification before the official audit

• Perform the audit (remotely) according to the predefined agenda

• Finalize the audit report and make recommendations on the items that will need actions later on

RESULTS OF THE PROJECT

• In the end the audit enabled a better dialogue between the client and its supplier.

• Better understanding about services and quality controls of the customer’s IT supplier 

• Action plan recommendations to improve the supplier quality control

• Checklist available for further IT service provider audits

• Auditing critical suppliers is a regulation requirement