Nalys was commissioned to do the requalification of subcontractor for the management of the servers hosting the SAP ERP as well as support for system maintenance.
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.
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
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
Conducting a remote audit was a very interesting experience. Despite the very short time we had, we managed to meet deadlines and commitments while issuing deliverables in line with the customer expectations. This was possible thanks to an excellent collaboration of all stakeholders.”