Computer Software Assurance

CSA and CSV

It's a complement to CSV not a replacement.
A way to focus on Patient risk, rather than the paperwork required for validation.

CSA Challenges

CSA is not new, it is based on existing regulations. However, the shift in focus in relation to documentation and testing requires expert intervention. We can provide guidance to: - Build trust in the risk-based approach to CSA - Redirecting resources to the right activities - Find the balance between testing and documentation  

Guidance

This document  supplements FDA's guidance "General Principles of Software Validation" ("Software Validation guidance") and supersedes Section 6 ("Validation of Automated Process Equipment and Quality System Software")

CSA and GAMP 5

GAMP 5 2nd Edition is aligned with current CSA guidance, in regard to patient safety, product quality and data integrity. The main issues highlighted in this edition surround innovation, agile methodologies and IT service management. The guidance shows a clear evolution from Computer Systems Validation (CSV) to Computer Software Assurance (CSA) 

Ad-hoc Testing 

It is important to note that “Ad-hoc” does not mean “Undocumented.” An Ad-hoc test case defines the test objective, but does not include detailed test steps.
Ad-hoc testing can increase detection of functional irregularities that may be encountered in the live environment.

It's about quality 

Computer Software Assurance is part of a broader trend being driven by industry bodies such as the FDA and the ISPE. It’s aimed at enhancing compliance based CSV activity with measured, sensible, quality-based CSA actions, for example, replacing manual paper-based systems with electronic systems.