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.

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Our di­gi­tiza­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the dls | eQMS is a ho­li­stic ECM/DMS sys­tem. The ECM/DMS sys­tem can be con­nec­ted to your exis­ting ERP sys­tem (e.g. SAP) and, thus, map al­most all do­cu­ment-ba­sed pro­ces­ses in the company.

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What does medical validation mean?

Me­di­cal va­li­da­ti­on de­scri­bes the de­ter­mi­na­ti­on of the va­li­di­ty of the test re­sults with re­spect to the re­se­arch ques­ti­on and re­pres­ents the
re­lease of a la­bo­ra­to­ry fin­ding 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 spe­ci­fi­ca­ti­ons de­scri­be in con­cre­te terms how the con­trac­tor in­tends to meet the con­trac­ting entity’s re­qui­re­ments. 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 va­li­da­ti­on in its 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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De­fi­ni­ti­on of the term (“What is the GAMP5?”) The GAMP5 is a set of gui­de­lines and best prac­ti­ces de­ve­lo­ped by the In­ter­na­tio­nal So­cie­ty for Phar­maceu­ti­cal Engineering

Device Master Record (DMR)

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