If you need a road map or help along the way, we can help.

Since it's inception, QualityHub has built it's reputation as an auditing organization. While our service offerings in the areas of remediation and other related services has grown, auditing has remained the foundation of QualityHub's services. In fact, auditing is our top requested service.

Types of Audits:

Our auditing services range from simple to complex. Examples:
• Supplier Audits.
• Contracted Internal Audits.
• "Baseline" audits following adverse FDA GMP/Quality System Inspections.
• FDA Certification Audits.
• Due Diligence Audits.
• We perform standard GMP/QSR audits for clients who wish to prevent FDA Inspection findings.

In the case where our FDA regulated clients have had FDA Inspection related 483s and Warning Letters we can perform Baseline Audits as well as Certification Audits. We service Consent Decrees as Independent Third Party Experts.

Our Auditors:

We can customize your audit to match our cadre of expert auditors with your particular product line and situation.
• Our company utilizes a cross section of ex-Industry experts and ex-FDA experts to perform our auditing services.
• Our average tenure is 25+ years in the FDA regulated industry.
• Our auditing expertise covers all areas within FDA's Medical Device Quality System requirements, as well as all areas in the Drug GMPs.

Our reputation for in-depth auditing meshes well with the FDA expectation that Executive Management must ensure that a thorough audit is performed at their facility.

Contact us to discuss your auditing and certification needs. Please visit our Connect page to contact us.