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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...
10 Things You need to know about Human Factors Validation

10 Things You need to know about Human Factors Validation

As medical devices become more complex, the FDA will continue to place greater emphasis on ways to improve safety and effectiveness before products are commercialized. One relatively recent method is Human Factors Engineering, also known as Usability Engineering, which is used to identify and mitigate use errors. Of course, this can place additional burdens on manufacturers to justify that their device has accounted for as many of these potential risks as possible. The list below, which is by no means exhaustive, is intended to point you in the right direction as you prepare for meeting FDA requirements for Human Factors Validation Testing. Human Factors should be considered throughout the design and development process, not just when you’re ready to go to market. Formative evaluations, such as focus groups and expert interviews, can and should be conducted throughout the design and development process. These studies usually consist of 5-8 people and can be conducted somewhat informally. Valuable information can be gleaned from formative evaluations, such as design improvements and identification of potential use errors that could be mitigated by making adjustments to the device interface. Additionally, the FDA and other notified bodies often want to see how your design has been influenced based on the results of these studies. Summative evaluations are the formal validation studies conducted for the final version of the device. These studies are your Human Factors Validation Testing that must follow the requirements of the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, and the EU standard, IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices. These studies...

ISO 14971

Achieve ISO 14971 Certification ISO 14971 specifies a process for medical device manufacturers to identify the hazards, or risks, that are associated with their products and to create the necessary controls to monitor them. Understanding this regulation is also critical to establishing the safety of your product per IEC 60601-1 3rd Edition Amendment 1 requirements. At MethodSense, our medical device consultants will help prepare your business operations and documentation to establish your compliance with ISO standards and enable you to demonstrate your commitment to product safety, quality and reliability. ISO 14971 Certification Solutions ISO 14971 establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. These activities are also required by higher level regulation and other quality standards, such as ISO 13485. Our medical device consultants work with you to: Assess the essential performance of your medical device Identify potential hazards Estimate the severity and likelihood of the hazards Create controls to minimize the risks Using InfoStrength Smart Enterprise Solutions, our regulatory document management tool, your materials will be organized in a way that makes it easy to demonstrate the safety and effectiveness of your device and risk management processes. Click here to learn more about our regulatory document management software. Our goal is to help you achieve easier compliance, more efficient validation and improved process management. SCHEDULE AN APPOINTMENT WITH ONE OF OUR REGULATORY AFFAIRS CONSULTANTS TODAY to ensure your device meets global commercialization...

ISO 13485

Achieve ISO 13485 Certification ISO 13485 is a Quality Management System standard designed for medical device companies. Being ISO 13485 compliant shows a commitment to the safety and quality of your medical devices. Documented compliance to an ISO Standard, even in the absence of certification, speaks volumes about how you run your company and the kind of partner you will be.  For globalizing your medical device outside the United States, ISO 13485 certification is almost always required. Our medical device consultants will help prepare your business operations and documentation to establish your compliance with ISO standards and enable you to demonstrate your commitment to product safety, quality and reliability. If you are currently compliant with FDA regulation 21 CFR Part 820, MethodSense will ensure a smooth and efficient compliance path by fully leveraging your current Quality Management System. ISO 13485 Certification Solutions Our solutions allow you to confidently manage your quality, manufacturing, business processes and much more, with document control, record retention and audit trails. We support ISO 13485 certification with our proprietary pre-validated software solutions, InfoStrength Smart Enterprise Suite and InfoStrength Smart Solutions. This tool, combined with our medical device regulatory expertise, enables you to: Understand the requirements for ISO 13486 certification Establish a risk based approach to product development and realization Complete the validation of processes Ensure compliance with regulatory requirements Implement effective product traceability and recall systems Using InfoStrength Smart Enterprise Solutions, our regulatory document management tool, your materials will be organized in a way that makes it easy to demonstrate the safety and effectiveness of your device and risk management processes. Click here to learn more about...

IEC 62304

Meet SDLC Requirements If your medical device has software that regulates its functionality in a way that contributes to Basic Safety or Essential Performance, then you will need to comply with IEC 62304. The standard requires all aspects of the software development life cycle (SDLC) to be appropriately managed to ensure patient safety, including: Development and code reviews Risk management Configuration management Incident and bug resolution Validation Maintenance IEC 62304 Management Solutions All these SDLC activities generate a great deal of documentation that can be difficult to interpret and keep organized and readily available when they are needed. We use InfoStrength’s solutions (our regulatory software) and our expertise to organize your IEC 62304 SDLC management documentation for easier compliance, faster validation, and better process management – so you can meet your commercialization goals sooner. Meet IEC 62304 requirements with: Easy yet controlled access to your most current relevant SDLC and other GMP procedures Incident and bug management from identification to resolution validation Organized IEC 62304 and other relevant tables A secure collaborative environment between quality, regulatory and software development personnel with the appropriate document management and version controls to enable a smooth work process A portal with role-based security to exchange content efficiently and conveniently with your Notified Body Our goal is to help you achieve easier compliance, more efficient validation and improved process management. Be prepared – SCHEDULE AN APPOINTMENT WITH ONE OF OUR REGULATORY AFFAIRS CONSULTANTS...