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Arbour Group understands key suppliers of materials, processes, parts, etc. must comply with the quality standards of their customer. We help life sciences companies ensure materials and process vendors establish and maintain quality standards that comply with industry standards, including FDA 21 CFR Parts 11, 211 and 820, as well as current industry best practices. Audits provide tangible feedback about a contracted manufacturer's compliance and provide objective evidence that an effective quality system is in place.

The content of the audit will vary depending on the product or service provided. However,

Arbour Group's time-proven process will include:

  • Pre-audit discussion of scope, plan, objectives and regulatory expectations
  • Review of system documents (such as SOPs) and previous quality assessments
  • Identification of quality-critical areas in the supplier's environment
  • Development a checklist that is specific to the assignment
  • Execution of the audit
  • Composition of audit report detailing compliance and non-compliance
  • Development of a corrective action plan

The Arbour Advantage

Arbour Group is a trusted advisor to over 250 pharmaceutical, medical device and biotechnology companies worldwide. Let us demonstrate how we can integrate seamlessly into your organization, prove ourselves a valuable business partner and deliver effective services that reduce compliance costs.

 

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