Required Roles: Editor, Reviewer
Required Permissions: View
Vendor Audit Report, a pre-configured (out-of-the-box), report provides the status of vendors that require an audit. Audits planned, completed, types of vendor, specific dates, certifications required and status of vendor with the organization can be determined from the report.
Vendor Audits and documentation fall under the following regulations: ICH Q10, ICH E6 R2 Section 5, and FDA Good Manufacturing Practices (cGMP).
Use Cases: Examples on how to utilize the report.
Filters: Use to create specific subsets of data in the report.
Columns: Use to sort data in the report.
Use Cases
Quality leaders and teams use vendor audit reports to understand historical patterns with particular vendors, anticipate future quality events, plan for upticks in volume, or decommissioning.
Inspection Readiness/Due Diligence: As part of an inspection or due diligence effort, vendor audit reports demonstrate compliance.
Support increase in vendor production at the ready: Audit reports help provide an overall picture based on any data point for a full list of current, past and future approved, denied and failed vendors. Ex. When starting a project to find a clinical drug supply lab, leaders want to know quickly the vendors are approved or not.
Filters and Columns
Filters allow users to narrow the data viewed. Users may request specific data points as filters.
Columns allow the data to be sorted in ascending or descending order.
Filters
In the example below, the following filters/columns are available and applied: Vendor Type, Audit Date, and Status.
a) Vendor Type: Refers to a customer-defined category of vendors. Examples include laboratory services, testing services, IT services, contractors, and manufacturing.
b) Audit Date: Refers to the audit's performed or planned date. Date options are highlighted below.
c) Status: Refers to the label given to a vendor for the audit outcome or stage in the process. Examples include Completed, Planned, or Pending Qualification. Labels can be configured per organization.
Columns
Data and information in the columns may be sorted to provide a different view. Clicking on the Column title will sort the items ascending or descending.
Name: This refers to the Vendor name. Vendor names may have a prefix applied as a naming convention, as seen in the example below. Prefix naming conventions are configurable per organization.
Audit Date and Vendor Type are defined above in the Filter section.