Gap Assessments & Audits

Audits are a quality system requirement for medical devices, and a good idea for any regulated product.  In addition to audits, gap assessments are a tool for revealing where elements may be missing in a process.  Together, gap assessments and audits help an organization to become its best, by revealing its worst.

Gap assessments and audits need to be performed by individuals who are not responsible for the process being audited.  In this way, the process is objective and the results are free from bias.  This is where Compliance Team can be involved.

Our process involves a clear understanding of the scope of the gap assessment or audit, creating a checklist of elements to check for, and systematically evaluating all items on the checklist.  Our process goes beyond evaluation of the items on the checklist, but preparation of a report that identifies the highest-risk findings and provides context around the findings so you have actionable information to make the necessary corrections.

Compliance Team can provide the following types of audits and risk assessments:

• Quality System Audits
• Mock Inspections
• Supplier Quality Audits
• Data Integrity Gap Assessments
• Production and Process Control-Centered Gap Assessments (cleanrooms, product control, validation gap/impact assessments etc.)

We can help you find QMS/process gaps so regulators won’t find them first.