VALIDATION OF COMPUTERIZED SYSTEMS – WHO – PDF Download

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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).
174
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.
180
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).

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