ISO TR 80002-2:2017 download

05-20-2021 comment

ISO TR 80002-2:2017 download.Medical device software — Part 2: Validation of software for niedical device quality systems.
ISO TR 80002-2 has been developed to assist readers in determining appropnate activities for the validation of process software used in medical device quality systems using a risk-based approach that applies critical thinking.
This Includes software used In the quality management system, software used in production and service provision, and software used for the monitoring and measurement of requirements. as required by ISO 13485:2016: and 7.6.
ISO TR 80002-2 is the result of an etTort to bring together experience from medical device industry personnel who deal with performing this type of software validation and who are tasked with establishing auditable documentation. The document has been developed with certain questions and problems In mind that we all go through when faced with validating process software used In medical device quality systems such as the following: What has to be done? How much Is enough? How is risk analysis Involved After much discussion, it has been concluded that in every case, a Set of activities (I.e. the tools from a toolbox) was identified to provide a level of confidence in the ability of the software to perform according to its intended use. However, the list of activities varied depending on factors including, among others, the complexity of the software, the risk of harm involved and the pedigree (e.g quality, stability) of vendor-supplied software.
The intention of this document Is to help stakeholders, including manufacturers, auditors and regulators. to understand and apply the requirement for validation of software included in ISO 13485:2016, 4.1.6, 7.5.6 and 7.6.
4.3 Critical thinking
ISO TR 80002-2 promotes the use o(crttlcal thinking to determine which activities should be performed to adequately validate specific software. Critical thinking Is a process of analysing and evaluating various aspects of software, as well as the environment In which it wi]l be used, to identify the most meaningful set of confidence-building activities to be applied during validation. Critical thinking avoids an approach that applies a one-size-fits-all validation solution without thoroughly evaluating the solution to determine If it indeed results In the desired outcome. Critical thinking recognizes that validation solutions can vary greatly from software to software and also allows for different validation solutions to be applied to the same software In a similar situation. Critical thinking challenges proposed validation solutions, to ensure that they meet the intent of the quality management system requirements, and considers all key stakeholders and their needs. Critical thinking is also used to reevaluate the validation solution when characteristics of the software change. when the softwares intended use changes or when new information becomes available.
Critical thinking results In a validation solution that establishes compliance for a manufacturer. ensures that the software Is sate for use, results In documented evidence that Is deemed appropriate and adequate by reviewers, and results in a scenario in which Individuals performing the validation work feels that the effort adds value and represents the most efficient way to reach the desired results.
AwaL.C presents example studies demonstrating how critical thinking can be applied to software validation of software used in medical device quality systems In a variety of situations, Including thiTerent complexities. pedigrees and risk levels.
5 Software validation and critical thinking
5.1 OvervIew
Throughout the life cycle of software for medical device quality systems, appropriate controls need to be in place to ensure that the software performs as Intended. Incorporation of critical thinking and application of selected confidence-building activities result in establishing and maintaining a validated stale of the software. EgstreJ depicts a conceptual view of typical activities and controls that are part of the life cycle from the moment the decision Is made to automate a process until the software is retired or Is no Longer used for medical device quality systems. Although Figure 1 depIcts a sequential model. in reality, the process is of an Iterative nature as elements arc defined, risks arc identified and critical thinking is applied.
When developing software for use In the medical device quality system, a fundamental confidence- building activity to be selected from the toolbox Is the choice of software development life-cycle model. The model chosen should include critical thinking activities that enable the selection of other appropriate tools during various life-cycle activities. The results of the analyses and evaluations used drive the selection of the most meaningful set of confidence-building activities to ensure that the software performs as Intended, This document does not mean to Imply or prescribe the use of any particular software development mode). For simplIcity, however, the remainder of this document explains the concepts of critical thinking within the context of a waterfall development model using generic names for the phases. Other software development models (e.g. iterative, spiral) can certainly be used as long as critical thinking and the application of appropriate tools are incorporated into the model.
of the process risk analysis. The second validation planning element drives the selection of tools from the toolbox to implement, test and deploy the software. The choice of tools is driven primarily by the software risk analysis. Such planning steps result from different types of risk analyses and are depicted as separate activities in this document. However, many times the steps are combined into one activity, which includes the different aspects of risk analysis and the resultant choices for proceeding with validation.
During the development phase of the life cycle, risk management and validation planning tasks are used to define the appropriate level of effort to be applied to the software and to determine what confidence- building tools to apply. This type of approach results In the completion of appropriate valueadded activities and verification tasks, which are the basis for establishing a validated state. Once these activities and tasks are executed, the tools and their associated results are cited In a validation report as support for the conclusion that the software Is validated.
Once deployed, the software moves into the maintenance phase of the software life cycle. During this period, the software Is monitored, enhanced and updated as dictated by the business needs or regulatory requirement changes. Change control activities use the same concepts as the initial approach that was applied during the development phase of the life cycle. Changes, however, are now assessed as to their effect on the Intended use, on the risk of failure, on the risk control measures that were applied during the initial development and on any functionality of the software Itself.
The retirement phase is the act of removing software from use either by removal of the process or by replacement of the software being used for the process.
The activities shown In FIgure 1 reflect the primary software life-cycle control activitIes. Other work streams include project management, process development, vendor management (if applicable), and possibly others, depending on the software being Implemented.
FIgure 2 depicts software life-cycle control activities and critical thinking within the context of other work stream activities. The critical thinking activities appear in the iterative risk analysis and validation work streams. It is important to have clear and formal delinitions of these work streams within the organization’s business model to ensure that a program properly manages the software from both business and regulatory perspectives.
Two major benefits arise from having high-quality and efficient documentation.
a) Complete software definition that is clearlyarticulated in documentation enables Full understanding of the software’s intended use and expected performance and IL enables the understanding of the lull Impact of any and all changes made to the software.
b) Record or validation planning and execution provides documented evidence of the decisions made as a result of critical thinking. Focusing this documentation around the evaluations or analyses performed and the resulting tool selections that target risk-based and meaningful confidence- building activities provides for a succinct understanding of the validation that was performed. With a summary of how the acceptance criteria were met, the documentation provides evidence that the activities completed ensure the software performs as Intended and Introduces acceptable levels of risk to the process it automates.
The extent oldocumentation produced is directly related to the level of effort applied to the validation of the software. The level of effort should be commensurate with risk. Therefore, the software validation approach discussed in this document bases the extent of documentation on the impact of the process failure. The greater the risk of harm to persons or to the environment posed by the process, the greater the extent of documentation expected. In addition, the higher risk of harm should drive a higher level of scrutiny of the documentation by multiple cross-functional peers, by higher levels of management within the company or by both
The organization of the life-cycle control information into documentation can vary depending on many factors, such as the technology used and the size or complexity of the software.
The Information should be organized In a manner that facilitates the auditing of the Information along with the ability to maintain evidence of a validated state during the maintain phase of the software life cycle.
How life-cycle control information is captured and documented depends on preferences and established policies of the parties performing the validation. Discretion is given to the parties validating the software regarding how the objective evidence of life-cycle controls is packaged and presented In documentation. From a compliance review perspective, the validation planning and reporting documentation should be established to provide a compilation of all value-added, confidence-building activities that were planned and executed in order to ensure that the software performs as intended. Essentially, this documentation is the key record of the choices made (decisions) on the basis of inputs (decision drivers) that embody the critical thinking process used to confirm that a complete software solution has been developed that meets the intent of the regulation and considers all key stakeholders and their needs.
NOTE The term documentatioa Is used to refer to the body of information that Is recorded, whether it Is recorded in an actual document or in tools that capture the information, such as requirements management tools,
7 Prerequisite processes
The methodology presented in ISO TR 80002-2 Is intended to operate fully within an effective quality management system in order to be more effective.
The aspects of a quality system that can have the most positive effect on the success of the critical thinking methodology Include asset and infrastructure management (human and hardware), change management (including configuration management) and vendor management. Detailing those aspects Is outside the copc of this document; each aspect Is addressed in other standards and documents within industry (see Bibliography). In addition, this document does not intend to associate specific roles or functions (e.g. quality assurance, management and manufacturing) with the activities in this document. Each company’s philosophy and human resource infrastructure will dictate the acceptable roles for performing validation activities.

Download infomation Go to download
Note: If you can share this website on your Facebook,Twitter or others,I will share more.

ISO 9885:1991 download free

ISO 9885:1991 download free.Wide-mouth glass containers - Deviation from flatness of top sealing surface - Test methods. ISO 9885 specifies two complementary test methods for the determination or the deviation from flatness of the top sealing surface...
Download Now

ISO 9009:1991 download

ISO 9009:1991 download.Glass containers — Height and non-parallelism of finish with reference to container base — Test methods. ISO 9009 specifies test methods for determining the height and the non-parallelism of finish with reference to the container...
Download Now

ISO 10076:1991 pdf free download

ISO 10076:1991 pdf free download.Metallic powders — Determination of particle size distribution by gravitational sedimentation in a liquid and attenuation measurement. The settling behaviour under gravity of a given mass of particles dispersed in an initially static...
Download Now


Anonymous netizen Fill in information