Audit Readiness

While all facilities within a Life Sciences Company should be audit-ready at any time, there are certain triggers that might warrant additional levels of preparedness:

 

  • Opening or expanding a facility
  • Launching a new product
  • Serious adverse events or recalls
  • Higher product class
  • Prior issues at other company facilities
  • Merger, acquisition, product purchases
  • Change in manufacturing registration
  • Major change in production equipment, approach or key ingredients

 

UL's Audit Readiness Solutions includes more than just periodic quality audits for manufacturers and their suppliers globally. We help you establish repeatable audit processes and success metrics that drive sustainable improvements in operations, supplier relationships, distribution and quality.

 

For example, our experienced and highly qualified auditors provide your company the assurance that your suppliers are complying with your standards on an ongoing basis, reducing the risk to your organization. We help your supplier quality team build a framework that results in clients achieving their quality improvement goals.

 

Through our solutions, companies can develop corrective actions for existing findings and create opportunities for improvements on an ongoing basis.

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Associated programs

GMP Inspection Readiness Program

GMP Inspection Readiness

UL’s GMP Inspection Readiness program teaches GMP compliance and readies employees for FDA inspections.

5 courses

Resources