Audit - a systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.

Let Horizon Phoenix put your mind at ease with:

• Mock USFDA QSIT assessment - what better way to sleep soundly than to know the USFDA can inspect your facility any time they wish. You can put your mind at ease when Horizon Phoenix experts provide you with an examination of your systems and help you identify shortcomings and implement corrective actions.
• Pre-assessment - an examination of your systems prior to an external audit. Horizon Phoenix experts help you identify shortcomings and implement corrective actions prior to a regulatory assessment or notified body registration or surveillance audit.
• Pre-contract - examination of potential supplier prior to entering into a contract.
• In-contract - identification and evaluation of the quality requirements implemented for the contract and the extent to which they satisfy your quality needs.
• Post-contract - to supplement and re-enforce your quality needs, e.g. retention of records and test data.
• Pre-merger - an independent evaluation of a potential partner prior to consummating a joint venture, investment or merger.
• Pre-acquisition - an independent evaluation of a potential acquisition to verify quality system, product testing or regulatory compliance claims prior to closing a sale.

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Why Horizon Phoenix?

A number of companies have completely outsourced their ISO 13485:2003 Internal Audit to Horizon Phoenix. If you too feel that you can benefit from timely, fully independent assessments of your operations, please contact us. It will cost a lot less than you think!

Click here to view a recent Testimonial from an FDA Audit client!