Below is a condensed version of the FDA draft guidance “Computer Software Assurance for Production and Quality System Software” with an emphasis on the information relevant to Grand Avenue Software (GAS) validation. These notes were gathered from the draft guidance document and the additional sources listed at the end of this article.
...
Computer Software Assurance for Production and Quality System Software draft guidance available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software
Issued for comments on September 13, 2022, on docket FDA-2022-D-0795. Comments submitted by November 14, 2022, were eligible to be considered when FDA begins work on the final version of the guidance.
When final, this guidance will supplement FDA's guidance, "General Principles of Software Validation" ("Software Validation guidance") except this guidance will supersede Section 6 ("Validation of Automated Process Equipment and Quality System Software") of the Software Validation guidance.Issued for comments on September 13, 2022, on docket FDA-2022-D-0795. Comments submitted by November 14, 2022, were eligible to be considered when FDA begins work on the final version of the guidance.
Purpose
The draft guidance provides recommendations on computer software assurance for computers and data processing systems used as part of medical device production or the quality system. The draft guidance describes the following:
...
Examples of Intended Uses
(Red text indicates example intended use applicable to Grand Avenue Software)
Direct Intended Uses | Supporting Intended Uses |
|---|---|
Software intended for automating production processes, inspection, testing, or the collection and processing of production data | Software intended for automating general record-keeping that is not part of the quality record |
Software intended for automating quality system processes, collection and processing of quality system data, or maintaining a quality record established under the Quality System regulation | Software intended for use as development tools that test or monitor software systems or that automate testing activities for the software used as part of production or the quality system, such as those used for developing and running scripts |
...
Examples of Process Risks
(Red text indicates example process risks applicable to Grand Avenue Software)
High Process Risk Features/Functions/Operations | Not High Process Risk Features/Functions/Operations |
|---|---|
Maintain process parameters that affect the physical properties of product or manufacturing processes that are identified as essential to device safety or quality | Collect and record data from the process for monitoring and review purposes that do not have a direct impact on production or process performance |
Measure, inspect, analyze and/or determine acceptability of product or process with limited or no additional human awareness or review | Used as part the quality system for Corrective and Preventive Actions (CAPA) routing, automated logging/tracking of complaints, automated change control management, or automated procedure management |
Perform process corrections or adjustments of process parameters based on data monitoring or automated feedback from other process steps without additional human awareness or review | Intended to manage data, automate an existing calculation, increase process monitoring, or provide alerts when an exception occurs in an established process |
Produce directions for use or other labeling provided to patients and users that are necessary for safe operation of the medical device | Used to support production or the quality system (see Supporting Intended Uses above) |
Automate surveillance, trending, or tracking of data that the manufacturer identifies as essential to device safety and quality |
...