IQ (Installation Qualification)

Definition of the term (“What is the installation qualification?”)

The in­stal­la­ti­on qua­li­fi­ca­ti­on, also known as IQ, is a pro­cess of ve­ri­fy­ing that all so­lu­ti­ons, equip­ment and plants in a pro­duc­tion fa­ci­li­ty have been in­stal­led ac­cor­ding to the manufacturer’s spe­ci­fi­ca­ti­ons. This pro­cess en­su­res pro­per pla­ce­ment and con­nec­tion of equip­ment and sys­tems to en­su­re pro­per ope­ra­ti­on. In ad­di­ti­on to that, it is en­su­red that the products/plants/solutions are ad­apt­ed to the re­qui­re­ments of the user and have thus been crea­ted in ac­cordance with the spe­ci­fi­ca­ti­ons (re­qui­re­ments spe­ci­fi­ca­ti­on ) and that suf­fi­ci­ent do­cu­men­ta­ti­on exists as pro­of for this.

Why is installation qualification important?

The si­gni­fi­can­ce of the in­stal­la­ti­on qua­li­fi­ca­ti­on in the phar­maceu­ti­cal in­dus­try can­not be over­sta­ted. Here are some re­asons why it is indispensable:

  • En­su­ring pro­duct qua­li­ty: The IQ en­su­res that all so­lu­ti­ons, equip­ment and plants are func­tio­ning pro­per­ly, en­su­ring the qua­li­ty and pu­ri­ty of the phar­maceu­ti­cal pro­ducts produced. 
  • Re­gu­la­to­ry com­pli­ance: Phar­maceu­ti­cal com­pa­nies must com­ply with strict re­gu­la­to­ry stan­dards. The IQ is a cri­ti­cal step in de­mons­t­ra­ting com­pli­ance with the­se regulations. 
  • Avo­i­ding down­ti­me: In­cor­rect in­stal­la­ti­on of so­lu­ti­ons or plants can re­sult in cos­t­ly down­ti­me. The IQ mi­ni­mi­zes this risk by ma­king sure ever­y­thing is working properly. 
  • Cost ef­fi­ci­en­cy: By iden­ti­fy­ing pro­blems ear­ly and en­su­ring a smooth in­stal­la­ti­on, com­pa­nies can save cos­ts in the long term.

The installation qualification process

The IQ con­sists of se­ve­ral steps that must be per­for­med carefully:

  • Step 1: Plan­ning: This step de­fi­nes the re­qui­re­ments for the IQ, in­clu­ding the so­lu­ti­ons, equip­ment and plants to be qualified. 
  • Step 2: Car­ry­ing out the qua­li­fi­ca­ti­on: The ac­tu­al qua­li­fi­ca­ti­on is car­ri­ed out pay­ing par­ti­cu­lar at­ten­ti­on to safe­ty-re­le­vant and pro­cess-cri­ti­cal aspects. 
  • Step 3: Do­cu­men­ta­ti­on: All qua­li­fi­ca­ti­on re­sults are careful­ly do­cu­men­ted to pro­ve com­pli­ance with the standards. 
  • Step 4: Re­port­ing: A com­pre­hen­si­ve fi­nal re­port will be pre­pared that in­cludes all tests and re­sults performed.

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Installation qualification challenges

While the IQ is of cri­ti­cal si­gni­fi­can­ce, it also pres­ents challenges:

  • Com­ple­xi­ty: Qua­li­fi­ca­ti­on can be com­plex, espe­ci­al­ly in lar­ge pro­duc­tion plants with many de­vices and systems. 

  • Time cons­traints: Per­forming the IQ can take time, which can af­fect over­all pro­duc­tion time.


The in­stal­la­ti­on qua­li­fi­ca­ti­on is an in­dis­pensable step in the phar­maceu­ti­cal in­dus­try to en­su­re the ef­fi­ci­en­cy and safe­ty of so­lu­ti­ons, equip­ment and plants. It con­tri­bu­tes to pro­duct qua­li­ty, en­su­res com­pli­ance and mi­ni­mi­zes down­ti­me. De­spi­te the chal­lenges, the IQ is a cor­ner­stone of any phar­maceu­ti­cal ma­nu­fac­tu­ring plant.

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Frequently Asked Questions (FAQs)

What is the main pur­po­se of the in­stal­la­ti­on qua­li­fi­ca­ti­on?
The main pur­po­ses of the in­stal­la­ti­on qua­li­fi­ca­ti­on are to en­su­re pro­duct qua­li­ty, com­pli­ance with re­gu­la­to­ry re­qui­re­ments, pre­ven­ti­on of down­ti­me, and cost efficiency.

Which in­dus­tries need in­stal­la­ti­on qua­li­fi­ca­ti­on?
In­stal­la­ti­on qua­li­fi­ca­ti­on is wi­de­ly used in in­dus­tries such as phar­maceu­tics, bio­tech­no­lo­gy and food manufacturing.

Are the­re al­ter­na­ti­ves to the in­stal­la­ti­on qua­li­fi­ca­ti­on?
The in­stal­la­ti­on qua­li­fi­ca­ti­on is a stan­dard pro­ce­du­re wi­de­ly used in the phar­maceu­ti­cal in­dus­try. The­re are no wi­de­ly spread al­ter­na­ti­ves to en­su­re the same safe­ty and quality.

What role does do­cu­men­ta­ti­on play in the in­stal­la­ti­on qua­li­fi­ca­ti­on?
Do­cu­men­ta­ti­on is cri­ti­cal to pro­ve that qua­li­fi­ca­ti­on has been pro­per­ly per­for­med and to en­su­re that all re­qui­red steps have been completed.

How long does the in­stal­la­ti­on qua­li­fi­ca­ti­on pro­cess usual­ly take?
The du­ra­ti­on of the pro­cess de­pends on the size and com­ple­xi­ty of the pro­duc­tion plant. It can last from weeks to se­ve­ral months.

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EU GMP guideline

De­fi­ni­ti­on of the term (“What is the EU GMP Gui­de­line?”) The EU GMP Gui­de­line, or the “EU Good Ma­nu­fac­tu­ring Prac­ti­ce” Gui­de­line, is a com­pre­hen­si­ve set