Validation of macro - scripts - programs used in statistical software (Minitab-SAS...

[v9991]

how do you validate the inhouse-developed programs - scripts - macros;
these macros are either based on
a) combination of functions (COTS - bundled)
b) combination of macros.....specific to application/use
c) external algorithms

how do you verify/validate them>?

 

[v9991]

Re: Validation of macro - scripts - programs used in statistical software (Minitab-SA

here's very few and interesting ones i came across....

Standards for Data Management and Analytic Processes in the Office of Surveillance and Epidemiology (OSE)

SAS Programs Validation In A GCP Regulated Environment

Risk-Based Approach to SAS Program Validation

Can Validating SAS Programs be Fun and Easy?

 

[Kales Veggie]

Re: Validation of macro - scripts - programs used in statistical software (Minitab-SA

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm

 

[sagai]

Re: Validation of macro - scripts - programs used in statistical software (Minitab-SA

Why would you validate these?

 

[v9991]

Re: Validation of macro - scripts - programs used in statistical software (Minitab-SA

reason for verification/validation is
1) the data-evaluation-assessment criteria is specific to design; programing/scripting is done specific to each study/product; hence it will be good/needed practice; (evaluation - assessment is towards proving the equivalence of test with reference)
2) Data is submitted to regulatory agencies.

 

[v9991]

Re: Validation of macro - scripts - programs used in statistical software (Minitab-SA

ref. esp sec b.....Standards for Data Management and Analytic Processes

ref. appendix.....THE QUALITY IMPERATIVE: SAS INSTITUTE'S COMMITMENT
TO QUALITY