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AAMI TIR36
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AAMI TIR36 2007 Edition, January 1, 2007 Validation of software for regulated processes
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Description / Abstract:
This TIR applies to any software used to automate device design,
testing, component acceptance, manufacturing, labeling, packaging,
distribution, and complaint handling or to automate any other
aspect of the quality system, as defined by the Quality System
Regulation (21 CFR 820), or QSR. In addition, the TIR applies to
software used to create, modify, and maintain electronic records
and to manage electronic signatures that are subject to the
validation requirements (21 CFR 11). This TIR can also be broadly
applied wherever software automates processes regulated by the
FDA.
This TIR applies to
• software used in the production of a device, and
• software used in implementation of the device manufacturer's quality system.
It does not apply to
• software used as a component, part, or accessory of a medical device, or
• software that is itself a medical device.
This TIR may provide useful information and recommendations to
• people responsible for determining the appropriate content and size of a validation effort;
• people responsible for performing the analyses and evaluations that drive the content or size determination;
• people responsible for planning and executing the validation activities;
• people responsible for reviewing and approving the adequacy of the validation effort; and
• people responsible for auditing, inspecting, and evaluating the validation for compliance to regulation.
The TIR discusses how the general provisions of the QSR apply to regulated process software and describes an approach to evaluating this software. However, the TIR does not list the tasks and activities that must be used to comply with the law. The TIR does not create or confer any rights for or on any person and does not operate to bind the user. An alternative approach may be used if such an approach satisfies the requirements of the applicable statute, regulations, or both. No specific methodology or specific validation technique or method is required or suggested by this TIR. For each software project, the responsible party should determine and justify the specific approach, the combination of software risk management activities to be used, and the level of effort to be applied. Specific training or experience in medical device quality management systems and the regulations governing these systems is recommended.
This TIR applies to
• software used in the production of a device, and
• software used in implementation of the device manufacturer's quality system.
It does not apply to
• software used as a component, part, or accessory of a medical device, or
• software that is itself a medical device.
This TIR may provide useful information and recommendations to
• people responsible for determining the appropriate content and size of a validation effort;
• people responsible for performing the analyses and evaluations that drive the content or size determination;
• people responsible for planning and executing the validation activities;
• people responsible for reviewing and approving the adequacy of the validation effort; and
• people responsible for auditing, inspecting, and evaluating the validation for compliance to regulation.
The TIR discusses how the general provisions of the QSR apply to regulated process software and describes an approach to evaluating this software. However, the TIR does not list the tasks and activities that must be used to comply with the law. The TIR does not create or confer any rights for or on any person and does not operate to bind the user. An alternative approach may be used if such an approach satisfies the requirements of the applicable statute, regulations, or both. No specific methodology or specific validation technique or method is required or suggested by this TIR. For each software project, the responsible party should determine and justify the specific approach, the combination of software risk management activities to be used, and the level of effort to be applied. Specific training or experience in medical device quality management systems and the regulations governing these systems is recommended.