Kymanox has a Global Audit Team consisting of certified auditors and seasoned Subject Matter Experts across a wide variety of disciplines. The Global Audit Team performs a variety of audits worldwide, including internal audits, external audits, gap assessments, and due diligence assessments. We also offer a variety of mock audits to prepare your organization for a pending regulatory body inspection. Kymanox has managed and executed audits for clients in the following industry sectors: pharmaceuticals, biologics, medical devices, including diagnostics, combination products, and computerized systems. From raw materials to API to finished products, and everything in between, Kymanox covers your auditing needs throughout the product lifecycle.
We specialize in providing top notch documentation and personalized support to our clients. Our auditors manage the logistics surrounding the audit with the audit sponsor and auditee to ensure the boundaries of the audit are well understood in accordance with the contracts in place and governing regulations. For the duration of the project and beyond, we are committed to audit follow-up and addressing all corrective actions with the audit sponsor or the auditee. We view auditing as a collaborative process between the audit sponsor and the auditee for the purposes of continuous improvement. Where deficiencies or non-conformities are present, we are equipped to help you determine the best course of action to address problem areas, in order to meet industry best practices or regulatory requirements.
We provide an audit team consisting of a lead auditor, supporting auditor(s), and Subject Matter Experts, as needed, depending on the scope of the audit. A lead or supporting auditor may also act as an audit scribe to take detailed notes throughout the audit, making sure all observations are clearly documented. We have turnkey audit toolkits and checklists that provide everything needed for the auditing process, including templates for quality agreements, audit notifications and agendas, audit summary reports, and various types of risk assessments. We follow industry best practices in audit execution consistent with the American Society for Quality’s (ASQ’s) approach to quality auditing.
KymanoxWORKS offers a GXP Regulatory Audit Toolkit. For more information, please view the package at our store.