Given the costs and commitments that come with the MDSAP, it’s critically important to prepare for success before auditors arrive. One of the most effective ways to ensure readiness for the initial audit is by performing a preliminary preparatory audit. This should be led by an objective, experienced third party consultant with intimate knowledge of program requirements and regulator expectations to ensure your quality system is fully prepared to meet expectations under the new program. If you engage an authorized MDSAP auditor for this initial assessment, their results can be used as part of the assessment even if you know you aren’t anywhere near ready.
Read our brochure to learn more about auditing and our full range of life science resourcing capabilities.