Contains Nonbinding Recommendations
18
· Benefit-Risk
o If a residual risk is deemed not acceptable according to the acceptability criteria in
the risk management plan and further risk control is not possible, the sponsor
should provide documented benefit-risk analysis to demonstrate that the benefits
of the intended use outweigh the residual risk, which may be referenced in other
benefit-risk assessment documentation.
(3) Risk Management Report
A risk management report should be provided to:
· Show how the risk management plan has been appropriately implemented.
· Demonstrate that the risk management file has been assessed by the appropriate
personnel and the overall residual risk is acceptable.
· Demonstrate appropriate methods are established for the collection and assessment of
relevant production and post-production information.
Software Requirements Specification (SRS)
The SRS documents the requirements
for the software which typically specifies inputs and
outputs, functions that the software will perform, hardware,
performance,
interfaces,
user
interaction, error definition and handling, intended operating environment, safety related
requirements derived from a risk assessment (Refer to Section VI.C Risk Management File) and
all ranges, limits, defaults, and specific values that the software will accept. For additional details
on what should be included in the software requirements specification, refer to the guidance,
“General Principles of Software Validation.”
The term “requirements” is used in this section as part of the term “Software Requirements Specification,” and
does not refer to a regulatory requirement.
Hardware requirements generally include, but are not limited to, requirements related to: microprocessors,
memory devices, sensors, energy sources, safety features, and communications.
Software performance and functional requirements generally include, but are not limited to, requirements related
to algorithms or control characteristics for therapy, diagnosis, monitoring, alarms, analysis, and interpretation with
full text references or supporting clinical data, if necessary. Software performance and functional requirements may
also include: device limitations due to software, internal software tests and checks, error and interrupt handling, fault
detection, tolerance, and recovery characteristics, safety requirements, and timing and memory requirements.
Interface requirements (e.g., external, user, internal) generally include, but are not limited to, both communication
between system components and communication with the user such as: printers, monitors, keyboard, mouse, cloud
servers, peripheral medical devices, mobile technology platforms.