In this presentation, Joga Gobburu talks about the need of good software practices, and FDA regulatory guidances. Very interesting presentation where the presenter goes over the following good software practices: Installation Restricted privileges Qualify Physical Functional Maintenance Revision controls (audit trials) Updates (vendor)
IT validation, 21 CFR 11 and Software Validation Resources
The Quality Assurance Journal
- Determination of Effectiveness of the ‘Square Root of N Plus One’ Rule in Lot Acceptance Sampling Using an Operating Characteristic Curve
- FDA Warning Letter: Avoidance and Advice
- Factors Affecting Drug Quality Problems in Thailand
- Framework for Activity of Ethics Committees in Ukraine
- Good Laboratory Practice (GLP) – Guidelines for the Development and Validation of Spreadsheets
- ISO/IEC 17025 Accreditation: Between the Desired Gains and the Reality