For drug and device manufacturers in the United States, electronic records created through computerized systems must be maintained in accordance with FDA’s 21 CFR Part 11 and EudraLex Volume 4 Annex 11 for EU jurisdictions. 

Audit trails are an important requirement contained in each, and both US and EU regulations offer manufacturers the criteria needed to develop specifications for verifying system conformity.

Specifically for audit trails, however, many questions arise surrounding the matters not explicitly covered in the regulations. If you have found yourself in need of guidance around audit trail requirements, this quick guide may offer some helpful clarification.

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Given the costs and commitments of certification through the Medical Device Single Audit Program (MDSAP), it’s critically important to prepare for success before auditors arrive.

One of the best ways to ensure readiness for the initial audit is by performing a preliminary preparatory audit. Ideally, this would be led by an experienced third party consultant with intimate knowledge of program requirements and regulator expectations, along with firsthand experience in the field helping other companies prepare.

We’ve summarized the anatomy of a MDSAP preparatory audit to offer a peek inside the process and what to expect if your organization intends to prepare for Notified Bodies prior to their arrival.

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The Medical Device Single Audit Program (MDSAP) stands to unify regulatory requirements and auditing activities for medical devices around the world. The program largely relies on adherence to ISO 13485:2016, which while more closely aligned to FDA's QSR than its earlier version, is still prompting device companies to make major changes to their Quality Management Systems (QMS).

One such change unique to the MDSAP is a new nonconformity grading system.

In an effort to make nonconformity grading more consistent, the MDSAP does away with traditional grading criteria such as “significant finding,” “regular finding,” and “significant opportunity for improvement,” and instead uses a point system described at length in the Global Harmonization Task Force (GHTF)’s Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange.

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Kevin Bryne and Brie Stoianoff featured on WKG Portland Today's 8's Heroes

The FDA Group's Director of Quality and Service Assurance, Brie Stoianoff, and her husband, Kevin Byrne joined the hosts of Portland Today to discuss their personal struggle with MS and how they're raising money to promote MS research in search of a cure.

Kevin was diagnosed with MS while deployed overseas, serving as an air cavalry commander with the U.S. Army.

Together, and with their 7-year-old daughter, Eleanor, their focus is a constant effort to endure the debilitating effects of this disease, fundraise for efforts to find a cure, and support all those living with MS.

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The Medical Device Single Audit Program (MDSAP) is a global initiative intended to accelerate medical device regulatory harmonization by allowing a single regulatory audit to satisfy the requirements of multiple jurisdictions around the world.

For manufacturers that have determined MDSAP certification is a valuable pursuit, (read our free white paper if you're still unsure) there are three general steps companies can take to prepare their organizations for the initial audit, which involves a review of impacted documentation to determine preparedness for an on-site assessment of both the head office and any critical locations.

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The Medical Device Single Audit Program (MDSAP) is an important new global initiative intended to harmonize regulatory efforts around the world.

But despite looming deadlines, comparatively few medical device companies have a meaningful understanding of the advantages (and disadvantages) of pursuing MDSAP certification and how to prepare accordingly.

We're hosting a free webinar offers a clear and practical guide to understanding what the MDSAP is, the kinds of device manufacturers that stand to benefit from it, what to consider before pursuing certification, and how to prepare for the audit sequence.

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