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By: AssurX

Last month an investigative report revealed that the U.S. Food and Drug Administration (FDA) has millions of “hidden” serious injury and malfunctions reports on medical devices. According to the report from Kaiser Health News, “Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” [ASR] repository, instead of being described individually as device-adverse events in the public database known as MAUDE.”

Medical experts trust the Manufacturer and User Facility Device Experience (MAUDE) to identify problems that could put patients in jeopardy—making products that are not in that database essentially concealed.

In 2017 alone, 480,000 injuries or malfunctions were reported through the ASR. The FDA has declined to provide a complete list of the approximately 100 devices that have been granted reporting exemptions. Requests for those data through the Freedom of Information Act could take up to two years.

Critics have pointed out that many of those devices, which include staplers, vaginal mesh devices, robotic surgical devices, breast implants, and heart valves, come from medical device industry leaders.

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By: AssurX

Proposed in 2012 and now in effect, the general data protection regulation (GDPR) is the newest landmark of data protection legislation. GDPR compliance legislation is designed to better protect personal data of individuals in the European Union (EU) by making companies more accountable for how they collect, use, share, and store data. Fines for noncompliance can reach up to €20 million, or 4 percent of the worldwide annual revenue of the prior financial year.

Set up for success

As a company dedicated to developing solutions for quality management and compliance, AssurX approached the extensive scope of GDPR compliance readiness with the expertise to identify, document, and remediate any process issues where data privacy is a concern.

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By: AssurX

When a change management system is designed effectively, it defines how strategies, procedures, and technologies will be applied to address changes in the business environment.

Implementing a change management process for quality and compliance requires planning and preparation. Starting with a solid strategy at the outset can create a change management system that is adaptable, builds in risk-based thinking, and improves the ability to anticipate and plan for change rather than react to it.

A well-designed change management process encourages collaboration during the preparation stage and streamlines the execution process at the same time. When staff understand and contribute to change, you are actively engaging a strong knowledge base and team of ombudsmen. In addition, odds increase substantially for adoption and support of the change.

Encouraging collaboration helps drive acceptance. This is one clear advantage of using a quality management software system that can be accessed via browser from any device, at any time, and from any location.

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By: AssurX

Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017, the FDA cited adulterated products and insanitary conditions as the two most common violations in drug manufacturing. Here are four ways an automated quality and compliance management system builds control into the production process with respect to adulteration and potential contamination.

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Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.

Inadequate corrective actions

An FDA investigation was conducted from January to February 2017 at a class II medical device manufacturer. The FDA laid out several concerns in its April 21, 2017, warning letter, noting areas of CAPA noncompliance.

Among other claims, the CDRH noted that CAPAs opened as far back as 2015 and 2016 did not have adequate corrective actions in compliance with the Title 21 CFR Part 820 Quality System (QS) Regulation.

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By: AssurX

The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on real-world evidence (RWE).

Responding to the Center for Devices and Radiological Health’s (CDRH’s) “Fiscal Year 2017 (FY 2017) Proposed Guidance Development,” the medical device trade group submitted its recommendations for how guidances should be prioritized. In addition to recommending revisions to existing guidances, AdvaMed also suggests which guidances should be withdrawn.

Guidance recommendations ranked

AdvaMed ranked each recommendation with a “high,” “medium,” or “low” priority based on how it affects medical device manufacturer members.

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The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.

The CDRH continues to put a premium on quality when it assesses a medical device manufacturer’s operations and product. The latest initiatives charge regulators and medical device manufacturers to work together more to produce the safest products possible.

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By: AssurX

A common pitfall in quality management system (QMS) process automation occurs with a poorly planned process automation strategy. Too often, the temptation is to automate all quality processes at once and streamline the entire eQMS process in one giant undertaking. However, real-world experience has proven that this approach is just not feasible for long-term quality management success.

What to consider

When prioritizing your quality and compliance processes, weigh the importance and interconnections each will have. The genesis of a leading-edge quality management and compliance ecosystem should start with one process determined by a key driving factor. Consider the following types of drivers when organizing your QMS:

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Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.

In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress approved the epic 21st Century Cures Act. If all goes according to plan, the FDA will have more funding to do its job—including more inspections of life sciences manufacturers.

The 21st Century Cures Act gives the FDA a bonus of $500 million over 10 years to further fund an initiative to use real-world evidence in regulatory decisions. That makes it all the more important for manufacturers to have a strong document management system in place to be able to organize, access, and have the ability to provide detailed data to the agency if requested.

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By: AssurX

If compliance with the North American Electric Reliability Corp. (NERC) Reliability Standards wasn’t complex enough, registered utilities must also factor in the regulatory nuances of the bulk power system’s (BPS) eight regional entities (RE), even as NERC emerges with new risk management expectations. Although there is plenty of regulatory—and physical—overlap amongst the eight REs, it is essential for utilities to understand where they fit in the puzzle.

Clear away the fog, and one fact comes into view: Solid record-keeping and document management are central to meeting NERC’s evolving risk-based approach to compliance monitoring and enforcement.