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

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.

Baseline Audits

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

EU MDR or EU IVDR Preassessment Audits

Discover and correct nonconformities before an “official” Notified Body audit. Are you preparing for an EU MDR or EU IVDR Notified Body certification audit or a recertification 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. For our customers transitioning to EU MDR/EU IVDR, we leverage proprietary EU MDR/EU IVDR assessment tools, and evaluate and document observations throughout the quality and regulatory system areas that are impacted by the new requirements. The audit provides you with a comprehensive understanding of your overall compliance to the EU MDR’s or EU IVDR’s quality and regulatory requirements. Our consultants can then support your needs to address and offer guidance for taking timely, effective corrective action.

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 – using MDSAP Process-Based Audit Model that the Auditing Organizations (AO) will use, calculate your MDSAP audit score, and identify your areas of biggest risk. 

Inspection Readiness Training

There is an art to effectively managing an inspection. Leveraging decades of experience from our technical experts who have hosted numerous inspections over their careers, Oriel STAT A MATRIX has created a workshop based training event that will show you and your team how to effectively set up a front room/back room audit approach and provide you with the tools you will need to ensure you are prepared to effectively navigate the challenges that FDA and Notified Body audits/inspections will present.  Unique to this training is the ability to tie the class to one of the audits described above, so that your team can practice their newly acquired skills under the guidance of a skilled coach and be well prepared when an FDA investigator or NB auditor arrives at your doorstep.

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, FDA’s QSR, EU MDR, and EU IVDR.

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.

Key Advantage 

Oriel STAT A MATRIX is a consulting company, not a certification or regulatory body, so our consultants can provide advice on how to remedy nonconformances.