regulatory and quality system professionals | 919.313.3960
5 Questions to Evaluate your Records v. Documents Management Practices

5 Questions to Evaluate your Records v. Documents Management Practices

Documents, documents everywhere.  But which are the records, which are documents—what is the difference and why does it matter? Even start-up medical device companies are neck deep in documentation.  In addition to documents generated during the creation and production of a product or combination device, additional documentation is generated while working with the FDA Q-Subs, submissions, and Quality System Regulations. No question about it, it’s daunting….and often misunderstood.  One common confusion we hear frequently is the difference between a “document” and a “record”, and how each should be managed.  Keep reading for insights into the difference between the two and best practices to help you manage each. 1. Documents vs. Records:  What’s the Difference? In short, records are a subset of documents. More specifically: Document: For a medical device company, a Document satisfies a regulatory need or requirement and is most often called a “Controlled Document.”   A Controlled Document is a reference document, which through the course of its lifecycle may be reviewed, modified and distributed several times. Controlled Documents may include documents and information for public disclosure including, but not limited to, marketing, sales and promotional materials, training materials, clinical and technical information, labeling, and product related documents such as manufacturing procedures. Record:  For a medical device company a Record is a document created to demonstrate both quality system conformance to specified requirements and the effective operation of the Quality Management System (e.g. Change Requests, CAPAs, etc.).  They are documents that provide objective evidence of activity performed, or results achieved, during the design, development and production of regulated product(s). This can include verification, validation data sheets, DHR records,...
Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

Take the Document Control System Quiz (SPOILER: it’s pass/fail there’s no partial credit)

How do you know your Document Control System is working properly within your medical device company? Take this quick Document Control Health Check-Up Questionnaire: Do you approve (via wet or electronic signature) documents prior to issue? If you use electronic signatures, have you thoroughly assessed their function for 21 CFR Part 11 compliance? Do your document changes go through an approved change control process? Are document changes reviewed by the same person or personnel within the same function who previously reviewed and approved the document? Are your changed documents formally approved again? Do you consistently issue unique revision numbers to documents according to established procedures? Do you consistently document a description of changes to documents according to established procedures?  Are approved documents available at point-of-use for affected personnel? Are documents of external origin identified and is their distribution controlled? Do you effectively prevent the use of obsolete documents? Are your documents backed up to ensure efficient retrieval in the event of disaster? Have you validated your document control process or your electronic document management system as appropriate? If you answered—without hesitation—“Yes!” to all these questions, you are in great shape. Congratulations! If you answered “No” or “Maybe”, or if you had to pause and really think about the answer, then you might need some assistance.   The amount of controlled content created by a medical device company is extensive.  Lack of document control can create regulatory risks, risks to your Intellectual Property, and erodes the value of your operations and assets. Don’t wait for an audit or adverse event to assess and improve your Document Control System. If you need...
Regulating Medical Devices Shapes Industry for the Better

Regulating Medical Devices Shapes Industry for the Better

This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes regulation is central to how a sector operates. We talk to Rita King, CEO of MethodSense and Russ King, President of MethodSense about why regulating medical devices and biotech/pharma companies is so critical. Most devices and innovations need to go through a complex system of regulatory approval. In order to obtain market entry, some argue that regulatory agencies like the US-based Food and Drug Administration (FDA) are too zealous, preventing or delaying life-saving innovations from entering the market. Richard Williams, an affiliated scholar at the Mercatus Center at George Mason University, cites an example where three medical devices submitted for approval took nine years to process. He argues that it costs on average $24 million to manage FDA requirements. “A mid-1970s law,” he argues, “requires virtually every medical device—and improvements to existing devices—to endure a slow, expensive, uncertain approval process, ill-suited to 21st-century technology. The Food and Drug Administration (FDA), which grants such approval, has an ageing structure and culture that adds extra layers of discouragement to would-be innovators.” But what are the benefits of regulation, and how can pharma and tech companies manage the process of compliance more smoothly? MethodSense is a company that exists to assist companies with FDA and other regulatory agencies to obtain market entry for their medical device products. We talked to Rita King, CEO of MethodSense, and Russ King, President of MethodSense, about what they do and why regulation matters. What kinds of services do you provide as a company? “MethodSense’s consulting service approach is a little...
FDA Oversight of Laboratory Developed Tests (LDTs) is on the Horizon

FDA Oversight of Laboratory Developed Tests (LDTs) is on the Horizon

How Do Laboratory Developed Tests Impact Your Business? The Office of Public Health Strategy and Analysis recently issued a report that reviewed 20 products that relied on Laboratory Developed Tests (LDTs) to determine whether a lack of oversight may have caused actual harm to patients or not. Once, LDTs were relatively simple tests that may not have warranted regulatory compliance. However, these tests are playing an increasingly more important role in healthcare and have become significantly more complex. The concern is that these tests may present with inaccuracies that place patients at what would be considered otherwise avoidable risk. The report found that these 20 products, in fact, may have caused actual harm to patients. In some cases, patients were told they have conditions they do not really have, due to false-positive tests. This led to unnecessary distress and resulted in unneeded treatment. In other cases, the LTDs produced false-negative results, in which life-threatening diseases went undetected. These misdiagnosed patients failed to receive treatments. Additionally, some LTDs provided information with no relevance to the condition they were intended to be used for, and others were linked to treatments based on disproven scientific concepts. Not only do these situations cause harm to patients, but they are also costly to society.(1) The report found that FDA oversight of LTDs is needed to address the following: Lack of evidence supporting the clinical validity of tests Deficient adverse event reporting No premarket review of performance data Unsupported manufacturer claims Inadequate product labeling Lack of transparency Uneven playing field Threats to the scientific integrity of clinical trials No comprehensive listing of all LTDs being used...
Colliding Cultures: Software Development and the Medical Device Industry

Colliding Cultures: Software Development and the Medical Device Industry

Part 1 – Medical Device Software, the FDA and the US Congress Preface: In any given 2-week period, an average of 15% to 20% of the applications on my smartphone have new versions to fix software bugs. Others I speak with experience similar statistics. And, that doesn’t include how often my smartphone software crashes while executing tasks it was intended to perform. We don’t complain about it. Instead, we accept this state of constant, almost continuous, software revision to fix bugs as a matter of “how things are.” We have come to terms with the fact that the normal state of software is for it to be broken, in need of repair and “acceptably” functional, while simultaneously defective. One might think, given the prevalence and importance of software, we would reject software disrepair as normal – especially for critical applications that impact safety. But, the evidence suggests otherwise. If you perform a search on the FDA Medical Device Recall Database from January 1, 2013 to August 14, 2015, you will see 500 device recalls reported. This is the maximum number of rows the FDA report supports in a single query (meaning more than 500 devices were recalled). Enter the keyword “software” into the search, and the query returns 344 recalls due to medical device software. Reviewing randomly through these notices confirms that software issues played an instrumental – or the only – role in the recalls. And, all but nine are Class I or Class II recalls in response to a risk of temporary or serious adverse health consequences due to software problems. Is software so difficult and challenging...
Implement 21 CFR Part 820 Controls Early On

Implement 21 CFR Part 820 Controls Early On

Benefits and Risks of Moving to the Cloud Migrating to the Cloud: What are the Benefits? According to the National Institute of Standards and Technology, the cloud is “a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.” Most companies’ IT infrastructure use less than 30% of their capacity. It took years to get the capacity to where it is today, and it takes months to increase capacity. Employing qualified resources to maintain such an infrastructure is difficult and expensive. Cloud providers utilize about 65% of their capacity and can add capacity quickly. In short, cloud providers benefit from economies of scale, which enables them to lower individual usage costs and centralize infrastructure costs. Companies benefit by only paying for what they consume. Companies can increase or decrease their usage rapidly, and can spend less time managing complex IT resources. Not only do efficiency improvements reduce costs, the nature of some costs can change from being capital investment in hardware and infrastructure (CapEx) to a pay-as-you go (OpEx) model. Maximizing IT capacity utilization, improving IT flexibility and responsiveness, and minimizing cost are not the only advantages of the cloud. Collaboration can be one of the most important advantages of cloud computing. Multiple users, from around the world, can collaborate more easily on documents and projects. Because the information is hosted in the cloud, and not on individual computers, business owners can collaborate with external stakeholders in a secure environment with nothing...