FDA has released draft guidance, “Computer Software Assurance for Production and Quality System Software” (dated September 13, 2022. CSA Guidance), dated September 13, 2022.
It provides recommendations pertaining to computer software assurance for computer and automated data processing systems used in the manufacture of medical devices or as part of quality systems.
The CSA guidance is intended to establish confidence in software used in medical device manufacturing or quality systems and to evaluate computer software through a risk-based approach to identify when additional rigorous assurance is appropriate.
The CSA Guidance also describes the various methods and testing activities that can be applied to provide objective evidence to meet the requirements for computer software verification required by 21 CFR Part 820 (QSR).
The finalized CSA guidance is the FDA guidance “General Principles of Software Validation” (issued January 2002. Hereafter referred to as the GPSV Guidance).
The CSA Guidance is not intended to explain all the principles of software validation.
In the GPSV Guidance, FDA outlines the principles of software validation, including implementing change management as part of the software lifecycle.
The CSA Guidance applies the risk-based approach to software validation described in the GPSV Guidance to software used in medical device manufacturing or quality systems.
When the CSA Guidance is finalized, it will replace Section 6, VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE, of the GPSV Guidance. The GPSV Guidance replaces Section 6, “VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE.
Please note that the CSA Guidance does not apply to design validation (as required by QSR §820.30) for software in a medical device (SiMD) and software as a medical device (SaMD). 30) for software in a medical device (software in a medical device, SiMD) and software as a medical device (software as a medical device, SaMD).
The table of contents of the CSA Guidance is below:
1.Intoroduction
2. Background
3.Scope
4. Computer Software Assurance
5. Computer Software Assurance Risk Framework
A. Identifying the Intended Use
B. Determining the Risk-Based Approach
C. Determining the Appropriate Assurance Activities
D. Establishing the Appropriate Record
Appendix A. Examples
Example 1：Nonconformance Management System
Example 2：Learning Management System (LMS)
Example 3：Business Intelligence Applications
The CSA guidance assesses the intended use of computer software, by the use of risk-based analysis of software that is part of a manufacturing or quality system,
It outlines a risk framework for computer software assurance that includes identifying appropriate assurance activities based on the level of risk identified and the creation of records to document that the system is operating as intended.
The CSA Guidance classifies process risks into “high process risk” and “not high process risk” and provides examples of each.
It also introduces computer software assurance methods that may be used depending on the classification of process risk.
In addition, the CSA Guidance addresses matters related to the creation of records that are deemed sufficient as objective evidence that computer software assurance has been established.
related product
[blogcard url= https://xn--2lwu4a.jp/qms-csv/ title=”QMS（手順書）ひな形 CSV関連” ]]]>
Comment