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Design history file

The design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part. This means that any material proving your device is compliant should be included in your DHF The design history file requirements live in 21 CFR Part 820.30, which contains the regulations for the design controls process. You'll have to refer to subsection j) for the specific text on DHF, but we managed to squeeze it in below: j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of device Section 820.3(e) in the QSR defines Design History File (DHF) as a compilation of records which describes the design history of a finished device. This definition is vague and therefore creates an opportunity for compliance issues. To avoid this, you should focus on two aspects of the definition There is also a definition for a DHF found in 21 CFR 820.3(e), Design history file (DHF) means a compilation of records which describes the design history of a finished device. The FDA provided an official interpretation of this requirement in the preamble when the QSR was published in 1996

Design History File-Ready Ideation is a set of tools that encourage creativity best practices while at the same time building the foundation of design controls. It is DHF ready because it is intended to be used long before the formal implementation of the QSR. It can also be used as a creative brief to build presentations and pitch decks A design history file (DHF) is the collection of artifacts used in the design process for a finished medical device. The design history file contains information related to a part structure (reference documents, change notices, change records, problem reports, variances, and so on). It contains anything that a managed baseline can contain. • The Design History File Objects table on the. According to the FDA, the design history file shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part (21 CFR Part 820.30). Each manufacturer shall establish and maintain a DHF for each type of device Design History File (DHF) - compilation of records which describes the . design history . of a finished device. • Device Master Record (DMR) - compilation of records containing the . procedures. an The FDA requires in 21 CFR Part 820.30 a Design History File DHF (these are the Quality System Regulations). DHF should not be confused with the Device History Record DHR or the Device Master Record DMR. This article explains what the Design History File must contain and how it differs from the other two artifacts

Design History File (DHF) vs

  1. A DHF is a Design History File and must contain or reference the records necessary to demonstrate that a design was developed in accordance with the approved design plans, and the requirements of the Quality Syste
  2. Design History File. The design history file is an FDA term described in 21 CFR Part 820.30, which talks about design controls and how they must be kept in a design history file (DHF). This is simply the collection of documents from the design and development process. Per FDA, Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference.
  3. DESIGN HISTORY FILE Purpose To set forth the requirements for initiating and controlling design history files (DHFs). Scope This procedure applies to design and development activities that are.
  4. A compilation of the records describing the entire history of the medical device design. It begins prior to development, is maintained through the product life, and includes design documents plus product change documents. Share this:Click to share on LinkedIn (Opens in new window)Click to share..
  5. DHF-design history file_预防医学_医药卫生_专业资料 866人阅读|32次下载. DHF-design history file_预防医学_医药卫生_专业资料。Design history file From Wikipedia, the free encyclopedia Jump to: navigation, search Design Histo
  6. Assists manufacturers in understanding the intent of the regulation. Design controls are based upon quality assurance and engineering principles

What is DHF (Design History File)? Greenlight Gur

The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF). (f) Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the. Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls on Each Rick Rutherford ON-DEMAND. 60 Minutes Categories: Medical Devices, Quality, Description; Presenter Details; After the Final Rule of the Quality System Regulation became effective, a moratorium on enforcement was placed for one year, until the ISO regulations went into effect. Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls on Each is an online event dedicated to the records that make up the key regulatory documents, the DHF, DMR and DHR.. Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls on Each covers topics such as Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration is a webinar that covers topics such as:. Quality System Regulation, 21 CFR Part 820, and ISO 13485 as it applies to DHF, DMR, and DH 2011 - Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained - Webinar By GlobalCompliancePane

How to Prepare your Design History File (DHF) for an FDA

The Caption Design History captured the steps taken in their design and could be found as a timeline underneath the components. With the Caption Design History feature on, edits to a user's components aren't possible. To turn the feature off, right click on the object listed under the Browser and select Do not capture Design History. Objects within the Fusion 360 file can now be. Version History allows you to view earlier versions of a file and restore or duplicate any version. Versions are automatically saved when there have been no changes to the file for 30 minutes. For example: Yuhki works in his file continuously for 3 hours, and then stops editing Design History File Certificate of compliance (pdf | doc) (Last updated 11-14-05) Clinical trial information (pdf | doc) (Last updated 11-14-05) Design Review records (pdf | doc) (Last updated 11-14-05) Design specification (pdf | doc) (Last updated 11-14-05) Design test protocols (pdf | doc) (Last updated 11-14-05.

DHF Template - Format and Content of Design History File

  1. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/DD. And how / where do the DMR.
  2. Design and Development File. The record contains all relevant information about the design and development process, including phases, responsible persons, and reference to the relevant documents. The document is optimized for small and medium-sized organizations - we believe that overly complex and lengthy documents are just overkill for you. This document is an appendix to the main document.
  3. Design History is a tool for tracking design changes in an active design file. It keeps track of what elements were modified, who made the changes and when they were done. Design History works at the element level to give a timeline to the design file. Having a history is essential to observe the progress of a file. In the current release of MicroStation V8, a single client uses Design.
  4. The Design History File (DHF) The Device History Record (DHR) The Device Master Record (DMR) Change Controls Impact of Change Controls on each Documentation associated with each Who Will Benefit: Research & Development Departments QA/QC Departments Regulatory Affairs Departments Quality Management Teams Documentation Departments Combination Products Design Personnel Production Teams Marketing.
  5. Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained - Webinar By GlobalCompliancePanel : April 06, 2011: Medical Research (others) GlobalCompliancePanel, Online Training Webinar 2011-05-11. Overview: This Webinar is designed for people involved in document preparation and maintenance, and those who have.
  6. Typical Technical File or Design Dossier contents. The importance and usefulness of the Essential Requirements. Structure of the Declaration of Conformity; self-declaring or N-B reviewed. Parallel approaches to development. Where the Device Master Record / Device History Record tie in

Design History File Ready Ideation Guidebook — Tri

Design History File (DHF) - Ihr automatisiertes digitales Archiv. am Mittwoch, 15. Mai 2019, 9:30-10:00 Uhr. Aus dem Inhalt: • Abbildung von Dokumentationszuständen • Zuordnung von Dokumenten zu Meilensteinen • Einheitliches und redundanzfreies digitales Archiv • Einfrieren von Zuständen des DHF als DHF Baseline • Unterstützung von digitalen Audits. Die Teilnahme am Webinar ist. Does Design History really increase the file size two-fold?: Keith Bentley provides this excellent explanation: Suppose you take a 500K file and enable Design History. Your file will immediately double in size for the first commit, since your file now will have two copies of every element: the live state and the history state. At this point your file is 1MB Howard Look moved [Phase 3: Design and Development] Ongoing - Design History File from In Progress to Completed and Under Document Contro The DHF is a key element of Design Control under the GMPs, and is a major subject for review during a U.S FDA compliance audit. Toll free: +1-800-447-9407 support@globalcompliancepanel.com Cart 0 items Sign In Sign Up. Home (current) Virtual Seminars ; Seminars ; Webinars . Live Webinars Recorded Webinars Recorded Webinars ($10) Consulting ; Membership . Join/Renew Benefits Package/Plans. Blog. Design History File (DHF): Ihr automatisiertes digitales Archiv. am Mittwoch, 15. Mai 2019, 9:30-10:00 Uhr. Aus dem Inhalt: • Abbildung von Dokumentationszuständen • Zuordnung von Dokumenten zu Meilensteinen • Einheitliches und redundanzfreies digitales Archiv • Einfrieren von Zuständen des DHF als DHF Baseline • Unterstützung von digitalen Audits. Die Teilnahme am Webinar ist.

Webinar on Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls on Each. Friday, April 22 2016, 1:00 PM - 2:00 PM [EST Git Virtual File System Design History. 02/21/2018; 14 minutes to read; In this article. By: Saeed Noursalehi. GVFS virtualizes the file system beneath a Git repo to solve two main problems: Only download contents that the user needs; Make local Git commands consider just the files that the user cares about, and not all the files that exist in the working directory ; Our target use case is the.

Video: Using the Design History File and Device Master Recor

How to Prepare Your Design History File For An FDA Inspectio

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A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient Shop Design History at Bloomingdales.com. Free Shipping and Free Returns available, or buy online and pick up in store

Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed Meggs' History of Graphic Design is the industry's unparalleled, award-winning reference. With over 1,400 high-quality images throughout, this visually stunning text guides you through a saga of artistic innovators, breakthrough technologies, and groundbreaking developments that define the graphic design field. The initial publication of this book was heralded as a publishing landmark, and. Graphic design is so much a part of our modern world that it is hard to imagine living without it. In some ways, we never have—design has been evolving nearly as long as we humans have! Join us as we trace the roots of graphic design from pre-industrial history into the industry we know today Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls on Each July 31, 2018 - Online Event ON CA Webinar Compliance. info@webinarcompliance.com Phone:416-915-4438/ 58 . After the Final Rule of the Quality System Regulation became effective, a moratorium on enforcement was placed for one year, until the ISO regulations went into effect.

There is a setting in the Preferences that will enable you to disable, enable, or prompt Design History (Parametric Modeling) by default when creating a new file. I note that when you use the Upload command in the Data Panel to import an STL file, the result is a Direct Modeling file with a Mesh Body in it. This is by design Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained : August 10, 2011: Pharma Development and Business : global compliance panel, Online Training Webinar 2011-08-25 Why you should attend: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your. 301 Moved Permanently. nginx/1.17.

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Under no circumstances can the file itself be sold or distributed. Design Type Regular cut . File Type . Studio. SVG. EXPRESS . License Type Personal Use Commercial Use . FREE . Design ID: 326177: File Size: 212.2 KB: Published: 2020-07-20 23:59:30: Description. This design is intended to be cut with an electronic cutting machine. Express Checkout. Add this item to my Silhouette Library. Free Download File Design wallpapers , Cricut Design Space, Handmade File Designs, SVG Monogram Mailbox Design, Project File Design, Google Material Design, Lever Arch File, Folder Layout, Graphic Design, Designer File Folders, Presentation Folder Design, Autodesk Design, Free Peacock SVG Cut File, Creative Folder Design, Filing Designs, Best Folder Design, Project File Front Page Design, DWG. Create a Store; Our Sites . Our Marketplaces All your Font Needs All your Design Needs Website Themes and More ; Community Forum New Communicate directly with our designers, customer support staff and fellow customers any time from anywhere!; Vector Pets New Custom hand drawn illustrations of your Pets!; Monogram Maker Use our quick and easy tool to create amazing monogram File:Antenna Design for FM.pdf. From doityourselfchristmas.com. Jump to: navigation, search. File ; File history; File usage; Antenna_Design_for_FM.pdf ‎ (file size: 1.55 MB, MIME type: application/pdf) Write up on theory and construction of 1/4 Wave Ground Plane Antenna by jhinkle File history. Click on a date/time to view the file as it appeared at that time. Date/Time Dimensions User.

Internet History of 1970s. 1970 . Nodes are added to the ARPANET at the rate of one per month. Programmers Dennis Ritchie and Kenneth Thompson at Bell Labs complete the UNIX operating system on a spare DEC minicomputer. UNIX combines many of the time-sharing and file-management features offered by Multics and wins a wide following, particularly among scientists. Bob Metcalfe builds a high. File Name: History of Graphic Design.pdf Size: 10.23 MB Uploaded: 2017-03-14 02:43:6. Status: AVAILABLE Last checked: 59 Minutes ago! Rating: ★★★★★ 97 out of 100 based on 14351 user Join our eBook service for unlimited books & audiobooks. Get a free 7 day subscription! ↓↓↓↓↓ Book Descriptions: A new edition of the history of graphic design which covers everything from the. Whether you're after sales, leads, more readers, or making a difference, bad web design can sabotage your efforts. Put your best foot forward with these principles of good web design But others were more outlandish, from likening Trump to Adolf Hitler's wife, to dropping F-bombs. Replying to the first lady's statement that the Rose Garden has been a symbol of strength and continuity and the renovation would preserve its history and beauty for generations to come, one Twitter commenter who describes themselves as a mental health counselor replied, Just what we need now.

Today, engineering design and testing mistakes are now causing aeroplane failures and repeatedly costing lives, and emissions scandals are just the start of our issues. Modern-day engineering ha Today, universal design can sound a little reductive and creaky, with its implication of a single norm, as if difference (physical, cognitive, racial, gender, religious, age, you name it. Graphic design a new history second edition pdf download - Book details Author: Stephen J. Eskilson Pages: pages Publisher: Yale University Press Language: English ISBN ISBN Microbial Biotechnology in Environmental Monitoring and Cleanup (Advances in. This books (Graphic Design: A New History, Second Edition [FREE]) Made by Stephen J. Eskilson About Books Title: Graphic Design(A New Viewpoints on Innovation is the go-to source for content and resources for new, current and future innovation executives‎ Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry

FDA Hot Topic

Download Design_History_Beyond_the_Canon_by_Jennifer_Kaufmann-Buhler-P2P.pdf fast and secure. Rapidgator . Rapidgator: Fast, safe and secure file hosting. News; Upload file. Web upload. Webinar On Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) February 24, 2015 - Mississauga ON CA Compliance Trainings. suzzane.d@compliancetrainings.com Phone:416915443 Live Webinar on : Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained. Thursday, August 09, 2012. duration: 01:00 to 02:00 PM EDT Get 15 % Discount as . a. early bird registrations. Use Promo Key : CGO15 Pricing. Live ( Single registration ) : $189.00. Group ( Max 10 Attendee): $249.00. On Demand (Recording.

-SVG file for use with Cricut Explore and other cutting machines; -DXF file for use with other software and cutting machines; -EPS files for use with cutting or vector editors software; -PNG 4000 × 4000 files with transparent background. Description: **** If you have a Specific Awareness Design you would like made, Just message me! I. One architectural benefit of this design is that you are decoupling the concerns of your app and your history/audit capabilities. This design would work just as well as a microservice using a relational or even NoSQL database that is separate from your application database. share | improve this answer | follow | edited Mar 17 at 23:20. answered Mar 3 '17 at 22:55. Luke Luke. 7,302 3 3 gold. If you are sure that your design is history based, then it is possible that the UI for the timeline has been lost. If so, try executing the Reset to Default Layout command: This will reset all the UI to the default state (you may lose some customization of the toolbar). That may bring back the timeline UI. Let me know if neither of these work for you, we can see what else might be the cause. History of Graphic Design, Graphic Designers, Art and Design Movements, Motion Graphics, Typography, Color, Design, graphic, Design, Reference, Referenced, A collection of information intended to be used as a primer and a reference tool in relation to the history of graphic design

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Technical File versus DHF - Johner Institut

Download Cricut Design Space old versions Android APK or update to Cricut Design Space latest version. Review Cricut Design Space release date, changelog and more Architecture and Interior Design: An Integrated History to the Present provides a survey of architecture, interiors, furniture, and decorative arts from the past to the present.It is a completely integrated and interdisciplinary reference for: architecture, architectural details, architectural surface treatments, space planning, interior design, interior architectural features, interior. Ansys engineering simulation and 3D design software delivers product modeling solutions with unmatched scalability and a comprehensive multiphysics foundation Increase efficiency—Use intuitive tools to measure, mark up, and review 2D and 3D designs on the desktop.; Enhance communication—Share changes with your extended team and stakeholders, even if they don't have the original design software.; Reduce costs—Eliminate paper and avoid misunderstandings.; Improved performance—Take advantage of enhanced features and tools for DWF Viewer and.

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Design History File (DHF) Template Example for Consideration

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Design History File vs

File Name. Directory. File ID. Content. Database Parameter History <database_name>.pah <independent_data_path> \config. DBMPAHI. History of the database parameters . Database Trace (Raw/Binary) knltrace. Run directory of the database. KNLTRC. Binary log file of the database trace; can also contain information about the cause crashes. The database system initializes this file each time the. File History before it's activated in Windows 10. Once you're there, hook up your external hard drive to Windows and then in the Settings app click the + next to Add a drive Styles, Periods and Design History This topic covers the varying styles and themes that have evolved over the recorded history of design. It covers the classics from Egyptian, Greek and Roman proportion types of construction and decoration to modern classics such as Art Deco and Art Nouveau and completes your education of the different forms of decoration and how they have evolved and what has. One of the best known CAD programs used in product design is SolidWorks, the flagship program of 3D design giants Dassault Systèmes. SolidWorks is a solid modeling software which enables the creation of 3D solids within numeric and geometric parameters. It is noted for its user-friendliness and the high degree of productivity that it allows for. SolidWorks helps designers to edit their pieces.

Design History File by Paramesha Param - Issu

The global creative platform for custom graphic design: logos, websites and more. Hire a talented designer or start a design contest. 500k+ happy customers have used 99designs to grow their business de·sign (dĭ-zīn′) v. de·signed, de·sign·ing, de·signs v.tr. 1. a. To conceive or fashion in the mind; invent: design a good excuse for not attending the conference. b. To formulate a plan for; devise: designed a marketing strategy for the new product. 2. To make a graphic or schematic representation of (something), especially as a plan for its. Art Deco, movement in decorative arts and architecture in Europe and the United States during the 1920s and '30s. Its distinguishing features include simple, clean shapes, often with a streamlined look; ornament that is geometric or stylized from representational forms; and unusually varied materials Home › Forums › General InDesign Topics › Plug-in documenting history of a file Tagged: Plug-Ins and Add-ons This topic contains 0 replies, has 1 voice, and was last updated by Paul Reeve 14 minutes ago. Author Posts June 2, 2020 at 5:02 am #125330 Paul ReeveMember Hi All First time here, so go easy! Does [ Apply for the renewed iF DESIGN AWARD 2021 competition - learn about design trends, find design jobs, events and articles on iF WORLD DESIGN GUID

Design History File - Strategy 2 Market Product Developmen

The Universal Design File THE CENTER FOR UNIVERSAL DESIGN A Brief History of Universal Design. 8 Efforts of the Veterans Administration, The President's Committee on Employment of the Handicapped, and the National Easter Seals Society, among others, resulted in development of national standards for barrier-free buildings. In 1961, the American Standards Association (later known as The. When using Windows 8 File History, all my files were correctly copied but I wrongly thought it had backed up my files twice as all of my Library's were duplicated in my Manual Backup Library. I excluded my Manual Backup Library, formatted my drive and tried to run file history. I saw msg. 'drive not recognised' I selected the drive again, then chose 'no' to move my files across as I had. The preference and support files for InDesign have similar locations. These files are primarily grouped into three locations, though there is data in additional locations as noted below. The Application folder: At the location of the application, or executable, are subfolders for presets and other.

DHF-design history file_百度文

Books Online Pdf Free. 1,848 likes · 61 talking about this. Download free books in PDF format. Read online books for free new release and bestselle V6 History. The Marmon Motor Car Company was one of the earliest pioneers of V6 engines. As part of a general progression towards engines with even greater power, Marmon built first a V2, then a V4, V6, V8, and finally a V16. In the early 1900s, Buick experimented with a design for a V6 but the engine was never used in any of its cars. V6 engines wouldn't find their way to mass market cars. This design of Black women are dope in svg format will help you to made a freat shirt or poster. All objects can be resized without any quality loss! With this purchase you will receive a package that contains the following files: 1x SVG file Other listings with Black Lives Matter tag you can fin Circling back to the QFN, a typical file name is as follows: QFN50P_300x300_16_150x150. The newer revision of the document will include another character or characters to define the footprint in greater detail. The point is to stick to a system. If you're starting with chaos for file names, then you want to make renaming your symbols part of each design effort, one board at a time. Twenty.

Design Control Guidance For Medical Device Manufacturers FD

Kanon Boot Camp Warrior Rank and File for Men, 100 ml - EDT Spray price from amazon in UAE. Compare prices and shop online now. Launched by the design house of Kanon. This masculine fagrance has a blend of bergamot, patchouli, jasmine, lily of the valley, cinnamon, sandalwoood, clary sage, and musk notes.. RECENTLY I HAD A CHANCE to see the Vectorworks Design Summit virtual keynote, an online event in lieu of this year's canceled user conference. Both the keynote and my post-interview with CEO Dr. Biplab Sarkar revealed a clearer picture of how Vectorworks is both growing organically out from its core base of users into vertical segments, and how BIM technologies play a central core role for. Developers file plans for Dennis + Ives in Rail Yard District. Share . The former Caribbean Cold Storage property west of Downtown Jacksonville will be converted into mixed-use space. by: Karen Brune Mathis Editor Developer Arch Partners LLC filed civil engineering plans with the city July 20 for its proposed Dennis + Ives development at 1505 Dennis St. near Downtown in the Rail Yard District. They Whispered To Her You Can't Withstand The Storm svg ,I Am The Storm Strong African Woman Black History Month SVG PNG Vector Art SVG PNG Designs for shirt , Cricut silhouette Cameo

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FX File Explorer Package name nextapp.fx,Business,Labels :FX|File|Explorer App description:FX File Explorer features a Material Design UI and new ways to transfer your files between devices and computers: * SMBv2 support. * New FX Connect transfers files from phone-to-phone with Wi-Fi Direct. Supports NFC to connect two phones by physically touching their backs together While the company must disclose certain information, since the company is at an early-stage they may only be able to provide limited information about its business plan and operations because it does not have fully developed operations or a long history. The company may also only obligated to file information periodically regarding its business, including financial statements. A publicly. Free vector icon. Download thousands of free icons of art and design in SVG, PSD, PNG, EPS format or as ICON FON This story was first published on July 15, 2020, and last updated on July 16, 2020. The Pixel 4a is an upcoming midrange smartphone developed by Google. Like the fan-favorite Pixel 3a before it.

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