Computer System Assurance (CSA)

Computer System Validation :-  "Confirmation by examination and Provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled " General Principles of software validation : final Guidance for Industry and FDA Staff 

" The FDA new  Approach to CSV, Computer System Assurance (CSA), represents a Step change in computer system validation,placing critical thinking at the center of the CSV Process, as opposed to a traditional almost size fits all approach

Computer System Assurance:- CSA " A Set of activities or actions to be performed to give confidence that the software functions a intenaded and meets the organization needs . these activities can 

includes solution selection analysis , vendor history and data market performance data , installation activity ,factory acceptance and risk based testing.

Terms:

1.  A Focus on testing  higher confidence in system performance.

2. Risk based "Assurance", applying the risk factor for Patient Safety.

3. Risk based "Assurance" , applying the risk factor for Product Quality Compliance.

4. Take Credit for Activity and upstream and Down stream risk Control.

5. Focus on Testing, Not Script.

6. Use transcript testing for low /medium risk components.

7. less Compulsory Paper Work.

8. Focus on 20:80 Ratio.

9. Determining a Risk based approch.

10. Deciding on methods and activities.

11. Documenting the appropriate records.

11. Tractability is still required.

12. Review and update your current policies to align with the CSA approach.

13. Consider as a computer system validation  tools to automate assurance activities.

14. Leverage your software supplier.

Note :- The CSA guidelines have not been released officially yet and implementing them will take some time.

 Reference :-  Some Specific guideline