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Baseline Assessments, Preassessment Audits/
FDA Mock Audits (QSIT)

Determine your current level of compliance to FDA cGMP, ISO 13485, and the Medical Device Single Audit Program (MDSAP).

An Oriel STAT A MATRIX baseline assessment, preassessment audit, FDA mock audit (QSIT audit), or MDSAP audit is a convenient, economical way to assess your current status against the requirements in a standard or regulation – before the results count.

Baseline Assessments

Find the gaps with a baseline assessment audit. Conducted at the start of your quality management system (QMS) implementation, a baseline or gap assessment analyzes your current level of compliance to relevant quality standards and/or regulations – including FDA cGMP, ISO 13485, and MDSAP. These assessments identify areas of noncompliance and conclude with a formal action plan – the roadmap – for achieving compliance.

Learn about how our proven 14-Step Process can guide your organization through the development, implementation, and registration of its QMS.   

Preassessment Audits

Discover and correct nonconformities before an “official” audit. Are you preparing for an initial certification audit or an FDA audit? If you are concerned about your readiness or face critical deadlines, consider a preassessment audit. These audits identify gaps you can address before the formal audit to maximize the chances for a successful certification audit.

Typically conducted 4-8 weeks before an official audit, preassessment audits occur at the end of an implementation program to identify any remaining weaknesses in a system. Consultants who were not part of the implementation team will identify any nonconformities you need to address and offer guidance for taking timely, effective corrective action.

FDA Mock Audits (QSIT Audit)

Test your internal systems and personnel before an FDA inspection. Using FDA’s Quality System Inspection Technique (QSIT), Oriel STAT A MATRIX auditors will act like FDA inspectors and assess your cGMP, GLP, GCP, and QSR processes. We can also share techniques for efficiently organizing FDA audits and managing multiple inspectors.

MDSAP Mock Audits

Is your company participating or considering participation in the Medical Device Single Audit Program (MDSAP)? Our experienced Lead Auditor Consultants can assess your current processes against the MDSAP requirements and help your organization implement any needed changes. Contact us to learn more.

Why Choose Oriel STAT A MATRIX?

Since 1968, organizations have relied on us for auditing services focused on management systems and regulatory compliance. Our global team of Lead Auditor Consultants average 25+ years of international and domestic life sciences industry experience. They have trained more than 130,000 auditors and have assisted hundreds of organizations regulated by FDA and global regulatory agencies to achieve conformance to internationally recognized standards and regulations such as ISO 13485 and FDA’s QSR.

We believe auditing is a powerful tool for ensuring ongoing compliance with relevant standards and requirements, identifying opportunities to improve management systems, and verifying that the resulting improvements are sustained over time. 

Our team is here to help. Call 1.888.532.6360 or contact us online ›