170 Computerized systems should be validated at the level appropriate for their intended use
171 and in accordance with quality risk management principles. This applies to systems used in all
172 good (anything) practices (GXP) activities (e.g. good clinical practice (GCP), good
173 laboratory practice (GLP) and good manufacturing practices (GMP)) (3).
175 1.2 The purpose of validation of a computerized system is to ensure an acceptable degree of
176 documented evidence that establishes confidence in the accuracy, reliability and consistency in
177 performance of the system in accordance with predetermined specifications. The validation data
178 should meet the principles of being attributable, legible, contemporaneous, original and accurate
179 (ALCOA) throughout the data life cycle.
181 1.3 Computerized system validation should ensure that all necessary technical and
182 procedural controls are implemented ensuring compliance with good documentation practices
183 for electronic data generated by the system (WHO guidance on good data and record
184 management practices, WHO Technical Report Series, No. 996, Annex 5, 2016) (4).
Continue at: http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guideline_Validation_Computerized_Systems-Appendix5_QAS16-667.pdf
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