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 a do­cu­men­ted pro­of that a cer­tain pro­cess con­ti­nuous­ly pro­du­ces a pro­duct that ful­fills the pre­vious­ly de­fi­ned spe­ci­fi­ca­ti­ons and qua­li­ty cha­rac­te­ris­tics. This is done to pre­vent any risk for hu­man bein­gs ari­sing from the pro­duc­tion pro­cess of qua­li­ty as­suran­ce pro­cess. This espe­cial­ly af­fects the me­di­cal tech­no­lo­gy and the phar­maceu­ti­cal industry.

What does software validation mean? 

In this con­text, the GMP gui­de­li­nes spe­ci­fy that the com­pu­ter sys­tems or soft­ware sup­por­ting the de­ve­lo­p­ment or pro­duc­tion of pro­ducts of the abo­ve men­tio­ned in­dus­tries must also be va­li­da­ted. The soft­ware must be able to ac­cess the de­si­red re­sults exact­ly, con­ti­nuous­ly and re­pro­du­ci­b­ly at all times. The FDA men­ti­ons the va­li­da­ti­on of soft­ware as a con­fir­ma­ti­on re­sul­ting from checks and the pro­vi­si­on of ob­jec­ti­ve evi­dence that the soft­ware spe­ci­fi­ca­ti­on com­plies with user re­qui­re­ments and the in­ten­ded use and that the re­qui­re­ments are con­sist­ent­ly met.

What does medical validation mean? 

The me­di­cal va­li­da­ti­on de­scri­bes the de­ter­mi­na­ti­on of the va­li­di­ty of the test re­sults in re­la­ti­on to the re­se­arch ques­ti­on and re­pres­ents the re­lease of a la­bo­ra­to­ry re­sult to the con­trac­ting entity
by a specialist.

Why is validation important? 

The va­li­da­ti­on should re­spond to the ques­ti­ons, if the soft­ware is ade­qua­te for the in­ten­ded use, if it pro­vi­des the re­qui­red func­tions, and if it is suf­fi­ci­ent­ly re­li­able and ef­fi­ci­ent. Com­pu­ter-ba­sed sys­tems play a cen­tral role when pro­du­cing and va­li­da­ting phar­maceu­ti­cal or me­di­ci­nal pro­ducts. This ex­p­lains why the sys­tems must be va­li­da­ted from a GMP point of view.

In ad­di­ti­on, va­li­da­ti­on pro­vi­des do­cu­men­ted pro­of that it is pos­si­ble to crea­te re­pro­du­ci­bi­li­ty. In other words, a com­pa­ny is ca­pa­ble of pro­du­cing the same end pro­duct un­der the same conditions.

What is the difference between a user requirement specification and a functional specification? 

The user re­qui­re­ment spe­ci­fi­ca­ti­on de­scri­bes in con­cre­te form how the con­trac­tor in­tends to meet the re­qui­re­ments of the con­trac­ting en­ti­ty. Howe­ver, the en­t­i­re claim is first de­scri­bed as pre­cise­ly as pos­si­ble by the con­trac­ting en­ti­ty in the user re­qui­re­ment specification.

Advantages of validations?

  • In­cre­a­sing the un­der­stan­ding and tracea­bi­li­ty of pro­ces­ses (sys­tems, data, chan­ge management, …)
  • In­cre­a­sed user con­fi­dence in the com­pu­ter-ba­sed system
  • In­cre­a­sed care in hand­ling data and documents
  • In­cre­a­se of data se­cu­ri­ty by me­ans of con­trol­led systems
  • In­cre­a­se of work ef­fi­ci­en­cy by me­ans of tes­ted and se­cu­red processes

What role does risk management play in this?

Risk ma­nage­ment is an im­portant ba­sis of qua­li­ty ma­nage­ment which should also be ap­p­lied to the va­li­da­ti­on in the va­rious forms and pha­ses. This re­sults in nu­me­rous qua­li­ty-re­le­vant and com­pre­hen­si­ble de­cisi­ons, which must also be do­cu­men­ted and pro­ven and which are in­clu­ded in the va­li­da­ti­on approach.

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