FDA Compliance Resource Library from EduQuest

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►►►Featured FREE Compliance Advisory from EduQuest:

Correlation (Cross-Walk) between 21 CFR 820

and Best Practices in Design Controls

Download this free 76-page EduQuest Advisory for a detailed "cross-walk" connecting your requirements under FDA's 21 CFR Part 820 (the Quality System Regulation) to the best practices in Design Controls -- as recommended by the experts at EduQuest.

With an easy-to-read matrix format, the Advisory links each Part and Subpart of the QSR to its impact on your Design Control activities. You'll see that FDA's expectations for Design Controls go well beyond those you find in Subpart C (21 CFR 820.30) -- usually considered the Design Control portion of the regulation.

This cross-walk is included in the training materials for EduQuest's popular two-day Design Control for Medical Devices training class. In addition to explaining FDA's Design Control rules in every-day language, the class allows you to be part of a fictional product design team and identify Essential Design Inputs and Outputs; validate and verify product design; efficiently handle Design Changes; and effectively transfer product design to the manufacturing floor and your suppliers. Click here for details on the Design Control for Medical Devices training class.

Annex 11: The EU's New Expectations for Regulated Computerized Systems

Side-by-Side Comparison of FDA's Part 11 and the EU's Annex 11

The Four Pillars of QSR Compliance:

Build Your Subsystems, Strengthen Them with Data Links

At first glance, FDA’s Quality System Regulations (QSR) for medical devices – contained in 21 CFR 820 – may make your eyes cross and your stomach churn. The rules are intimidating, yes – but impossible to follow, no. Focus on four key quality subsystems – and connect and strengthen those subsystems with relevant data – and you’ll go far in meeting FDA’s expectations for quality products, processes and systems. And not so incidentally, mastering those key subsystems also will keep your ISO auditors happy, thanks to FDA’s efforts to harmonize its regulations with international standards. MORE

Understanding Objective Evidence: What It Is and What It Definitely Is Not

As you likely know, computer system validation requires objective evidence -- evidence that proves the results of a particular system will be consistent throughout its operating lifetime. But do you really understand what constitutes objective evidence -- from a scientific and a legal perspective -- and of great importance to those subject to regulatory inspections -- from the perspective of the FDA? Let’s answer the question by first understanding what objective evidence is not. MORE

The 9 Most Common Validation Errors:

Identify Frequent Deficiencies to Accelerate Your Validation Projects

What validation problems are you likely to see over and over? When tackling complex validation challenges, you’ll save time, money and headaches when you know the most common problems and where to find them. The following analysis is based on validation work EduQuest performed for a large FDA-regulated company over the past year. The goal was to bring the company’s software validation evidence up to the level of the U.S. FDA’s current expectations as well as those of the client’s own independent auditor. MORE

The Hot Potato of Responsibility: How to Manage Outsourcing and Not Get Burned

Medical Device Concessions: Free Pass or Red Flag for Your Quality System?

Under regulatory guidance not well understood within the industry, the U.S. FDA allows medical device manufacturers to release "nonconforming products" using what’s known as a concession. The danger is that some manufacturers tend to rely on concessions as fall-back remedies when they lose control of their processes and produce out-of-spec products. Instead of immediately identifying and correcting quality problems at their source -- which is what the FDA expects -- these manufacturers are quick to claim a concession and then move on with business-as-usual, hoping the problems are not serious and will eventually correct themselves. MORE

2018 FDA Inspections Operations Manual (IOM)

The primary source of FDA policy and procedures for field investigators and inspectors. Considered "the bible" for FDA inspections. Updated annually by FDA; this is the complete 2018 version with all individual chapters and exhibits combined into one integrated PDF document. 526 pages. For additional information on how to use this resource to assess your inspection readiness, purchase the EduQuest Advisory "Using FDA's Own Playbook to Prepare for Your Next Audit" from the Amazon Kindle Store.

FDA Inspection of Medical Device Manufacturers

Guidance document representing FDA's current thinking on the enforcement of the Quality System (QS), Medical Device Reporting (MDR), Medical Device Tracking, Corrections and Removals, and the Registration and Listing Requirements. Document 7382.845 of the FDA Compliance Program Guidance Manual. Implementation date of February 2, 2011. 70 pages.

FDA Drug Manufacturing Inspections

Guidance to FDA inspectors for evaluating compliance with cGMP requirements. Document 7356.002 of the FDA Compliance Program Guidance Manual. Implementation date of February 1, 2002. 30 pages.

FDA Guide to Inspections of Quality Systems (QSIT)

Guidance to the FDA field staff on an inspectional process that may be used to assess a medical device manufacturer's compliance with the Quality System Regulation (QSR) and related regulations. The inspectional process is known as the Quality System Inspection Technique or QSIT. The process for performing subsystem inspections is based on a "top-down" approach to inspecting. Published August 1999. 108 pages.

FDA Medical Device Quality Systems Manual: A Small Entity Compliance Guide

FDA withdrew this Compliance Guide in December 2013 because it was not in step with the Agency's movement towards harmonizing its guidance to ISO and other international standards. Still, the Manual, which was published in 1999 and was designed as an aid to auditors and QA managers, provides educational materials, aids, and examples of procedures and control forms for implementing elements of a quality system. 373 pages.

FDA Development and Validation of Spreadsheets for Calculation of Data

FDA's internal guidance for the design and validation of in-house spreadsheets and other numerical calculation programs used in the Agency's laboratory operations. Volume III, Chapter 4.5 of the FDA ORA Laboratory Manual. Effective date of October 1, 2003, and revised January 13, 2013. Two pages.