Auditing is the on-site verification activity — inspection or examination of a process or quality system — to ensure compliance to requirements. FDA requires establishments to periodically perform an internal audit, and SafeLink consultants can perform these on your behalf.
The purpose of the audit is to establish conformance with FDA Good Manufacturing Practices — verifying that your Quality System has been correctly communicated and is practiced. It is followed by a written Audit Report indicating any non-conformances, giving you a checklist to ensure the standards established by your Quality System are being followed. SafeLink can also perform Second Party Audits of suppliers and subcontractors, and Third Party Audits for certification to a recognized standard such as ISO.
Audit Types SafeLink Performs
Our compliance advisors are ready to help you stay ahead of inspections, regulatory changes, and the evolving risk landscape. Whether you need a one-time assessment or a long-term advisory partner, SafeLink will build a solution that fits your industry, your team, and your budget.
Serving businesses nationwide since 1991 including dental practices, dental laboratories, medical, device manufacturers, and general industry.
This site is operated by SafeLink Consulting, Inc., which uses cookies (and other similar technologies) to understand how you use the site, to provide a better website experience, and to deliver, measure, and personalize content.
Click the "Accept" button below to provide consent to our use of cookies for the purposes disclosed via this interface. You may also click the "Consent Options" button below to learn more about our use of cookies (including necessary cookies), their purposes, and to manage your consent choices. For more information on managing or withdrawing consents and how we handle data, visit our Privacy Policy.
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
The technical storage or access that is used exclusively for statistical purposes.
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.