General Principles of Software Validation,This guidance outlines general validation principles that the Food and Drug Administration

GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS

GUIDELINES ON VALIDATION – APPENDIX 5 3 VALIDATION OF COMPUTERIZED SYSTEMS

We are Australia's government authority responsible for evaluating, assessing and monitoring

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals

‘GXP’ refers to the various good practices regulated by the UK MHRA, including the Good Laboratory

The ISPE GAMP® Guide: Records and Data Integrity provides principles and practical guidance

A basic principle of assuring the quality of healthcare products is