eDMS

Elec­tro­nic do­cu­ment ma­nage­ment system

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Validation

De­fi­ni­ti­on of the term (“What does va­li­da­ti­on mean?”)  Va­li­da­ti­on plays a spe­cial role in all re­gu­la­ti­ons of the GxP en­vi­ron­ment. Fun­da­ment­al­ly, the va­li­da­ti­on me­ans providing

EU GMP Guidelines Chapter 4

The chap­ter 4 re­la­tes to the do­cu­men­ta­ti­on. A good do­cu­men­ta­ti­on is an es­sen­ti­al part of the qua­li­ty ma­nage­ment. Mo­reo­ver, it con­sti­tu­tes a key func­tion for