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Quality Systems

  • Do the Quality Systems of the manufacturers meet regulatory expectations?
  • Does this cover all markets?
  • Will you need to help a manufacturer prepare for a Regulatory Inspection?
  • What is the relationship like with the Regulatory Authorities?
  • What do the Product Quality Reviews tell you?
  • What is the complaints record like?
  • Has the product ever had to be recalled?
  • Have there ever been any quality “near misses”?

Management Team and Structure

  • Are the right people in place, and will they continue to be in place for you?
  • Are they properly trained, and is this adequately recorded?

Buildings and Equipment

  • Are they properly designed and constructed?
  • Are they qualified and properly maintained?
  • Are IT systems secure and fit for purpose?
  • Are all relevant systems validated according to regulatory expectations?
  • Will you inherit any potential future Health, Safety or environmental liabilities?