Prepare Introduction
A presentation to orient the auditor to the REMS functions being performed is very helpful, but it should not be a company marketing presentation. The auditor will be most interested in:
- A short summary of the company’s services and products, facilities’ locations and sizes (number of staff), and corporate structure (especially in REMS-related areas)
- Key staff performing REMS-related functions, their titles, roles and responsibilities
- Short history of the vendor’s participation in the REMS program
- History of Regulatory inspections and outcomes
- If audited previously, changes made since last audit (including changes in policies, procedures, processes, software, key staff, facilities).
