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Test analysis and identifying test conditions gives us a generic idea for testing which covers quite a large range of possibilities. June 9, 1. 99. 7. U. S. Department of Health and Human Services. Food and Drug Administration. Software testing is the process used to measure the quality of developed software. Software testing, depending on the testing method employed, can be implemented at any time in the development process. Traditionally most of. System Testing. General Testing Books particularly recommended books are stated below: Black Box. Boris Beizer, Black Box Testing, Wiley, 1995. Rick D. Craig and Stefan P. Jaskiel, Systematic Software Testing, Artech House. 08B51CI101: Software Testing and Debugging. Course Credit: 4. Semester: V. Introduction This course will examine fundamental software testing and program analysis techniques. In particular, the important phases of testing. Fuzz testing or fuzzing is a software testing technique, often automated or semi-automated, that involves providing invalid, unexpected, or random data to the inputs of a computer program. The program is then monitored for. Go to Poka-Yoke Page Using Poka-Yoke Techniques for Early Defect Detection Harry Robinson Paper presented at the Sixth International Conference on Software Testing Analysis and Review (STAR'97) Abstract Poka-yoke is a quality. Software testing is an investigation conducted to provide stakeholders with information about the quality of the product or service under test. [1] Software testing also provides an objective, independent view of the software. Center for Devices and Radiological Health. Center for Biologics Evaluation and Research. Preface. Public Comment. Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5. Fishers Lane, Room 1. HFA- 3. 05), Rockville, MD, 2. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance which involve the Center for Devices and Radiological Health (CDRH), contact John F. Murray at 3. 01- 7. For questions regarding the use or interpretation of this guidance which involve the Center for Biologics Evaluation and Research (CBER) contact Jerome Davis at (3. Additional Copies. CDRHAdditional copies are available from the Internet. You may also send an e- mail request to CDRH- Guidance@fda. Please use the document number (9. CBERAdditional copies are available from the CBER Internet web site, by writing to CBER, Office of Communication, Training, and Manufacturers' Assistance (HFM- 4. Rockville Pike, Rockville, Maryland 2. Table of Contents. General Principles of Software Validation. This document is intended to provide guidance. It represents the Agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. This final guidance document, Version 2. General Principles of Software Validation, Version 1. June 9, 1. 99. 7. This guidance describes how certain provisions of the medical device Quality System regulation apply to software and the agency's current approach to evaluating a software validation system. For example, this document lists elements that are acceptable to the FDA for the validation of software; however, it does not list all of the activities and tasks that must, in all instances, be used to comply with the law. The scope of this guidance is somewhat broader than the scope of validation in the strictest definition of that term. Planning, verification, testing, traceability, configuration management, and many other aspects of good software engineering discussed in this guidance are important activities that together help to support a final conclusion that software is validated. This guidance recommends an integration of software life cycle management and risk management activities. Based on the intended use and the safety risk associated with the software to be developed, the software developer should determine the specific approach, the combination of techniques to be used, and the level of effort to be applied. While this guidance does not recommend any specific life cycle model or any specific technique or method, it does recommend that software validation and verification activities be conducted throughout the entire software life cycle. Where the software is developed by someone other than the device manufacturer (e. FDA regulations. In that case, the party with regulatory responsibility (i. This guidance applies to: Software used as a component, part, or accessory of a medical device; Software that is itself a medical device (e. Software used in the production of a device (e. Software used in implementation of the device manufacturer's quality system (e. This document is based on generally recognized software validation principles and, therefore, can be applied to any software. For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 2. Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy. This document does not specifically identify which software is or is not regulated. This guidance provides useful information and recommendations to the following individuals: Persons subject to the medical device Quality System regulation. Persons responsible for the design, development, or production of medical device software. Persons responsible for the design, development, production, or procurement of automated tools used for the design, development, or manufacture of medical devices or software tools used to implement the quality system itself. FDA Investigators. FDA Compliance Officers. FDA Scientific Reviewers. We believe we should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet. The FDA's analysis of 3. Of those software related recalls, 1. Software validation and other related good software engineering practices discussed in this guidance are a principal means of avoiding such defects and resultant recalls. Software validation is a requirement of the Quality System regulation, which was published in the Federal Register on October 7, 1. June 1, 1. 99. 7. See Title 2. 1 Code of Federal Regulations (CFR) Part 8. Federal Register (FR) 5. Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in production of the device or in implementation of the device manufacturer's quality system. Unless specifically exempted in a classification regulation, any medical device software product developed after June 1, 1. See of 2. 1 CFR §8. This requirement includes the completion of current development projects, all new development projects, and all changes made to existing medical device software. Specific requirements for validation of device software are found in 2. CFR §8. 20. 3. 0(g). Other design controls, such as planning, input, verification, and reviews, are required for medical device software. See 2. 1 CFR §8. 20. The corresponding documented results from these activities can provide additional support for a conclusion that medical device software is validated. Any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use, as required by 2. CFR §8. 20. 7. 0(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system. In addition, computer systems used to create, modify, and maintain electronic records and to manage electronic signatures are also subject to the validation requirements. See 2. 1 CFR §1. 1. Such computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. Software for the above applications may be developed in- house or under contract. However, software is frequently purchased off- the- shelf for a particular intended use. All production and/or quality system software, even if purchased off- the- shelf, should have documented requirements that fully define its intended use, and information against which testing results and other evidence can be compared, to show that the software is validated for its intended use. The use of off- the- shelf software in automated medical devices and in automated manufacturing and quality system operations is increasing. Off- the- shelf software may have many capabilities, only a few of which are needed by the device manufacturer. Device manufacturers are responsible for the adequacy of the software used in their devices, and used to produce devices. When device manufacturers purchase "off- the- shelf'' software, they must ensure that it will perform as intended in their chosen application. For off- the- shelf software used in manufacturing or in the quality system, additional guidance is included in Section 6. For device software, additional useful information may be found in FDA's Guidance for Industry, FDA Reviewers, and Compliance on Off- The- Shelf Software Use in Medical Devices. This document addresses Quality System regulation issues that involve the implementation of software validation. It provides guidance for the management and control of the software validation process. The management and control of the software validation process should not be confused with any other validation requirements, such as process validation for an automated manufacturing process. Device manufacturers may use the same procedures and records for compliance with quality system and design control requirements, as well as for pre- market submissions to FDA. This document does not cover any specific safety or efficacy issues related to software validation. 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Nokia 6. Nokia 6. 23. 4Nokia 6. Nokia 6. 23. 5i. Nokia 6. Nokia 6. 26. 0Nokia 6. Nokia 6. 26. 5Nokia 6. Nokia 6. 26. 7Nokia 6. Nokia 6. 27. 5Nokia 6. CDMANokia 6. 27. 5i. Nokia 6. 27. 5i CDMANokia 6. Nokia 6. 28. 2Nokia 6. Nokia 6. 29. 0Nokia 6. Nokia 6. 30. 0i. Nokia 6. Nokia 6. 30. 3 classic. Nokia 6. 30. 3c. Nokia 6. Nokia 6. 30. 3i classic. Nokia 6. 35. 0Nokia 6. Nokia 6. 50. 0 Classic. Nokia 6. 50. 0 Slide. Nokia 6. 50. 0c. Nokia 6. Nokia 6. 55. 5Nokia 6. Nokia 6. 60. 0Nokia 6. Nokia 6. 60. 0 slide. Nokia 6. 60. 0i slide. Nokia 6. 60. 0i Slide. Nokia 6. 61. 0Nokia 6. Nokia 6. 62. 0Nokia 6. Nokia 6. 65. 0Nokia 6. Nokia 6. 65. 1Nokia 6. Nokia 6. 68. 0Nokia 6. Nokia 6. 68. 2Nokia 6. Nokia 6. 70. 0 classic. Nokia 6. 70. 0 Slide. Nokia 6. 70. 0c. Nokia 6. Nokia 6. 71. 0 Navigator. Nokia 6. 72. 0 classic. Nokia 6. 73. 0 classic. Nokia 6. 75. 0 Mural. Nokia 6. 76. 0 slide. Nokia 6. 78. 8Nokia 6. Nokia 6. 79. 0 slide. Nokia 6. 79. 0 Surge. Nokia 6. 80. 0Nokia 6. Americas. Nokia 6. Nokia 6. 82. 0Nokia 6. Nokia 7. 02. 0Nokia 7. Prism. Nokia 7. 10. Supernova. Nokia 7. Nokia 7. 20. 0Nokia 7. Nokia 7. 21. 0 Supernova. Nokia 7. 21. 0c. Nokia 7. Nokia 7. 25. 0Nokia 7. Nokia 7. 26. 0Nokia 7. Nokia 7. 31. 0 Supernova. Nokia 7. 31. 0c. Nokia 7. Nokia 7. 36. 0Nokia 7. Nokia 7. 37. 3Nokia 7. Nokia 7. 50. 0 Prism. Nokia 7. 51. 0 Supernova. Nokia 7. 51. 0a. Nokia 7. Nokia 7. 61. 0Nokia 7. Supernova. Nokia 7. Nokia 7. 90. 0 Prism. Nokia 8. 60. 0 Luna. Nokia 8. 80. 0Nokia 8. Arte. Nokia 8. 80. Carbon Arte. Nokia 8. Carbon Arte. Nokia 8. Gold Arte. Nokia 8. Gold Arte. Nokia 8. Sirocco. Nokia 8. Nokia 8. 80. 1Nokia Asha 2. Nokia Asha 2. 01. Nokia Asha 2. 02. Nokia Asha 2. 03. Nokia Asha 2. 05. Nokia Asha 2. 10. Nokia Asha 3. 00. Nokia Asha 3. 02. Nokia Asha 3. 03. Nokia Asha 3. 05. Nokia Asha 3. 06. Nokia Asha 3. 08. Nokia Asha 3. 10. Nokia Asha 3. 11. Nokia C2- 0. 1Nokia C2- 0. Nokia C2- 0. 3Nokia C2- 0. Nokia C2- 0. 6Nokia C3- 0. Nokia C3- 0. 1Nokia C3- 0. Gold Edition. Nokia C5- 0. Nokia C5- 0. 3Nokia C6- 0. Nokia C6- 0. 1Nokia C6- 0. Nokia C7 Astound. Nokia C7- 0. 0Nokia E5- 0. Nokia E5. 0Nokia E5. Nokia E5. 2Nokia E5. Nokia E6- 0. 0Nokia E6. Nokia E6. 1Nokia E6. Nokia E6. 2Nokia E6. Nokia E6. 5Nokia E6. Nokia E7- 0. 0Nokia E7. Nokia E7. 1Nokia E7. Nokia E7. 2Nokia E7. Nokia N- Gage. Nokia N- Gage. QDNokia N7. 0Nokia N7. Nokia N7. 2Nokia N7. Nokia N7. 5Nokia N7. Nokia N7. 7Nokia N7. Nokia N7. 9Nokia N8. Nokia N8. 0Nokia N8. Nokia N8. 1 8. GBNokia N8. Nokia N8. 5Nokia N8. MPNokia N9. 0Nokia N9. Nokia N9. 1 8. GBNokia N9. Nokia N9. 3Nokia N9. Nokia N9. 5Nokia N9. GBNokia N9. 5- 3. NAMNokia N9. 6Nokia N9. Nokia N9. 7Nokia N9. Nokia T7- 0. 0Nokia X2. Nokia X2- 0. 0Nokia X2- 0. Nokia X2- 0. 2Nokia X2- 0. Nokia X3. Nokia X3- 0. Nokia X3- 0. 2Nokia X6. Nokia X7- 0. 0O2 Xda Cosmo. O2 Xda IQO2 Xda Phone. O2 Xphone. O2 Xphone IIOrange MPx. Orange SPVOrange SPV C5. Orange SPV C5. 50. Orange SPV C6. 00. Orange SPV E1. 00. Orange SPV E2. 00. Palm Treo 7. 50. Panasonic X7. Pan. Tech PN- 8. 20. Pan. Tech Sky Qbric. Pan. Tech Sky Qbric IIQtek 7. Qtek 8. 01. 0Qtek 8. Qtek 8. 06. 0Qtek 8. Qtek 8. 10. 0Qtek 8. Qtek 8. 31. 0Qtek 8. Sagem my. S- 7. Samsung Blackjack. Samsung G. Armani B7. Samsung i. 60. 0Samsung Jet S8. Samsung Omnia II GT- i. Samsung Omnia II SCH- i. Samsung Omnia Pro GT- B7. Samsung Pixon. 12 GT- M8. Samsung SGH- D7. 20. Samsung SGH- D7. 30. Samsung SGH- i. 30. Samsung SGH- i. 32. Samsung SGH- i. 40. Samsung SGH- i. 45. Samsung SGH- i. 52. Samsung SGH- i. 55. Samsung SGH- i. 56. Samsung SGH- Z6. 00. Samsung SPH- W8. 50. Samsung SPH- W8. 50. Samsung SPH- W8. 55. Samsung T- Omnia SCH- M4. Samsung T- Omnia SCH- M4. Samsung Vodafone GT- i. Samsung Vodafone GT- i. Samsung Wave s. 85. Sierra Wireless Voq. Sony Ericsson C7. Sony Ericsson C9. Sony Ericsson F5. Sony Ericsson G5. Sony Ericsson G7. Sony Ericsson G9. Sony Ericsson J2. Sony Ericsson J3. Sony Ericsson K3. Sony Ericsson K3. Sony Ericsson K5. Sony Ericsson K5. Sony Ericsson K5. Sony Ericsson K5. Sony Ericsson K5. Sony Ericsson K6. Sony Ericsson K6. Sony Ericsson K6. Sony Ericsson K6. Sony Ericsson K7. Sony Ericsson K7. Sony Ericsson K7. Sony Ericsson K7. Sony Ericsson K7. Sony Ericsson K8. Sony Ericsson K8. Sony Ericsson K8. Sony Ericsson K8. Sony Ericsson M6. Sony Ericsson P1. Sony Ericsson P9. Sony Ericsson R3. Sony Ericsson R3. Sony Ericsson S5. Sony Ericsson S7. Sony Ericsson S7. Sony Ericsson T3. Sony Ericsson T6. Sony Ericsson T6. Sony Ericsson T6. Sony Ericsson T6. Sony Ericsson T6. Sony Ericsson T6. Sony Ericsson T6. Sony Ericsson V6. Sony Ericsson W2. Sony Ericsson W3. Sony Ericsson W3. Sony Ericsson W3. Sony Ericsson W5. Sony Ericsson W5. Sony Ericsson W5. Sony Ericsson W6. Sony Ericsson W6. Sony Ericsson W6. Sony Ericsson W7. Sony Ericsson W7. Sony Ericsson W7. Sony Ericsson W8. Sony Ericsson W8. Sony Ericsson W8. Sony Ericsson W8. Sony Ericsson W8. Sony Ericsson W9. Sony Ericsson W9. Sony Ericsson W9. Sony Ericsson W9. Sony Ericsson W9. Sony Ericsson Z1. Sony Ericsson Z2. Sony Ericsson Z3. Sony Ericsson Z3. Sony Ericsson Z5. Sony Ericsson Z5. Sony Ericsson Z5. Sony Ericsson Z6. Sony Ericsson Z6. Sony Ericsson Z6. Sony Ericsson Z7. Sony Ericsson Z7. Sony Ericsson Z7. Sony Ericsson Z7. T- Mobile Dash. T- Mobile SDAT- Mobile SDA (US)T- Mobile SDA Music. Pocket. PC 2. 40x. Smartphone 1. 76x. Smartphone 2. 40x. Smartphone 3. 20x. Windows Mobile 6. X4. 00. Browse. Categories. Browse Pages: 1 2 3 4 5 6 7 Next >. Loading content. There is a problem with loading the content. Origin. The Slender Man was created on June 10, 2009 on a thread in the Something Awful Internet forum. The thread was a photoshop contest in which users were. Slender: The Arrival is the official videogame adaption of Slender Man, developed in collaboration with Eric 'Victor Surge' Knudson, creator of the paranormal. Did you already wanted to be the Slender Man? Even for a short time? So, today i made one game when, unlike you run from Slender man, this time they will run from you! To Download Slender Click here: http:// To download Winrar Click Here: http:// If you. Be The Slender Man by Caio Varalta on Game Jolt. Did you already wanted to be the Slender Man? Even for a short time? So, today i made one game when, unlike you run from Slender man, this time they will run from you! Slender: The Arrival: Creepy survival video game that was introduced in 2013. Slender Title. This article is about the video game. For the entity, see Slender Man. Slender (known as Slender: The Eight Pages as of v0.9.7) is an independently. If you liked the hugely popular Slender and the Slenderman myth that it's based on, then you might like Slenderman which is a free game that was actually released. Slender: The Arrival is a survival horror video game developed by Blue Isle Studios as a sequel to Parsec Productions' Slender: The Eight Pages, with Chapter 6 being. New Slender Man Sightings and Evidence caught on tape in 2014, Slender Man, Monster, Paranormal Researcher David Weatherly talks all about Slender Man. This is a Mini Game/ Puzzle/ Horror/ Comedy game. It's really an other category game! But, i hope you like it! Use the arrow keys to move and enter to act/kill/scare and help your son! PS: To put fullscreen press alt+enter. |
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