CAPA (Corrective and Preventive Action)

Definition of the term (“What is CAPA?”)

CAPA (Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tion) is a pro­cess wi­thin the qua­li­ty ma­nage­ment sys­tem (QMS) and a com­po­nent of GMP-com­pli­ant work. In this case, er­rors or non-con­for­mi­ties that oc­cur are ana­ly­zed in a struc­tu­red man­ner (Cor­rec­ti­ve Ac­tion) or pre­ven­ti­ve ac­tions are im­ple­men­ted (Pre­ven­ti­ve Action).

Com­pared to other QMS stan­dards such as ISO 9001, CAPA is os­ten­si­bly not a con­ti­nuous im­pro­ve­ment pro­cess in the form of ste­adi­ly in­cre­asing pro­duct qua­li­ty. In­s­tead, the fo­cus is on re­me­dy­ing any de­via­ti­ons that oc­cur from re­qui­re­ments ba­sed on ap­pli­ca­ble le­gis­la­ti­on and tech­ni­cal stan­dards on me­di­cinal pro­ducts and me­di­cal de­vice safety.

Why is CAPA important?

  • En­su­ring qua­li­ty: Qua­li­ty is the cor­ner­stone of any suc­cessful busi­ness. CAPA plays a cen­tral role in main­tai­ning and im­pro­ving pro­duct and ser­vice qua­li­ty. By ad­dres­sing pro­blems prompt­ly and sys­te­ma­ti­cal­ly, com­pa­nies can de­li­ver con­sis­tent qua­li­ty to their customers. 
  • Com­pli­ance with le­gal re­qui­re­ments: In today’s high­ly re­gu­la­ted in­dus­tries, com­pli­ance with go­vern­ment stan­dards and re­gu­la­ti­ons is non-nego­tia­ble. CAPA helps com­pa­nies com­ply with re­gu­la­ti­ons by iden­ti­fy­ing and re­sol­ving de­via­ti­ons from in­dus­try standards.

What are the components of CAPA?

  • Root cau­se ana­ly­sis (RCA): RCA is the first step in the CAPA pro­cess. It in­vol­ves a tho­rough in­ves­ti­ga­ti­on to de­ter­mi­ne the root cau­ses of a pro­blem. Iden­ti­fy­ing the root cau­se is cri­ti­cal for im­ple­men­ting ef­fec­ti­ve cor­rec­ti­ve and pre­ven­ti­ve ac­tions.
  • Cor­rec­ti­ve me­a­su­res: Cor­rec­ti­ve ac­tions are spe­ci­fic me­a­su­res ta­ken to ad­dress the im­me­dia­te pro­blem or non­con­for­mi­ty. The­se me­a­su­res are ai­med at eli­mi­na­ting the pro­blem and pre­ven­ting its recurrence. 
  • Pre­ven­ti­ve ac­tions: Pre­ven­ti­ve ac­tions are proac­ti­ve me­a­su­res de­si­gned to pre­vent si­mi­lar pro­blems from oc­cur­ring in the fu­ture. They in­clude pro­cess im­pro­ve­ments, trai­nings and on­go­ing monitoring.

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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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How is a CAPA introduced?

Do­cu­men­ta­ti­on and re­cord kee­ping: A tho­rough do­cu­men­ta­ti­on of CAPA ac­ti­vi­ties is cri­ti­cal for trans­pa­ren­cy and com­pli­ance. De­tail­ed re­cords of in­ves­ti­ga­ti­ons, me­a­su­res and re­sults are essential.

What challenges are there in CAPA implementation?

  • Re­sis­tance to ch­an­ge: CAPA im­ple­men­ta­ti­on of­ten re­qui­res ch­an­ges to exis­ting pro­ces­ses. Em­ployee re­sis­tance to ch­an­ge can re­du­ce the ef­fec­ti­ve­ness of CAPA initiatives. 
  • Li­mi­t­ed Re­sour­ces: CAPA ac­ti­vi­ties can be re­sour­ce in­ten­si­ve. Or­ga­niza­ti­ons need to de­ploy the ne­ces­sa­ry re­sour­ces to en­su­re the suc­cessful im­ple­men­ta­ti­on of cor­rec­ti­ve and pre­ven­ti­ve ac­tions. This can be coun­ter­ac­ted with the help of sui­ta­ble CAPA-soft­ware


In sum­ma­ry, cor­rec­ti­ve and pre­ven­ti­ve ac­tion (CAPA) is an im­portant tool for or­ga­niza­ti­ons see­king to im­pro­ve their pro­ces­ses, main­tain qua­li­ty, and meet re­gu­la­to­ry re­qui­re­ments. By un­der­stan­ding the com­pon­ents of CAPA and over­co­ming the chal­lenges of im­ple­men­ta­ti­on, or­ga­niza­ti­ons can achie­ve ope­ra­tio­nal ex­cel­lence. When you em­bed CAPA as a cul­tu­re in your com­pa­ny, you pave the way for con­ti­nuous im­pro­ve­ment and long-term success.

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Frequently Asked Questions (FAQs)

How of­ten should CAPA pro­ce­du­res be re­view­ed?
CAPA pro­ce­du­res should be re­view­ed re­gu­lar­ly, at least an­nu­al­ly, to en­su­re they re­main ef­fec­ti­ve and updated.

Are the­re soft­ware so­lu­ti­ons for ma­na­ging CAPA pro­ce­du­res?
Yes, va­rious soft­ware so­lu­ti­ons can stream­li­ne CAPA ma­nage­ment and make it more ef­fi­ci­ent and or­ga­ni­zed. You can find a qua­li­fied so­lu­ti­on here, for example. 

Can CAPA also be ap­pli­ed in in­dus­tries other than ma­nu­fac­tu­ring?
Ab­so­lut­e­ly. CAPA prin­ci­ples can be ap­pli­ed in any in­dus­try or sec­tor that aims to im­pro­ve pro­ces­ses and main­tain quality.

What role does top ma­nage­ment play in the im­ple­men­ta­ti­on of CAPA?
Se­ni­or ma­nage­ment should lead and sup­port CAPA in­itia­ti­ves and en­su­re that they are ali­gned with the company’s stra­te­gic goals.

How can or­ga­niza­ti­ons me­a­su­re the ef­fec­ti­ve­ness of their CAPA ef­forts?
The ef­fec­ti­ve­ness of CAPA ef­forts can be me­a­su­red by track­ing key per­for­mance in­di­ca­tors (KPIs) such as re­du­ced de­fect ra­tes, im­pro­ved com­pli­ance and cus­to­mer satisfaction.

Whe­re does the term CAPA come from?
The term CAPA ori­gi­na­tes from me­di­cal de­vice re­gu­la­ti­ons and was also de­scri­bed in the ori­gi­nal sys­tem ele­ments in ISO 9001, ISO 13485, and FDA 21.

When was CAPA first in­tro­du­ced?
CAPA was first in­tro­du­ced in 2006 via the FDA’s “Qua­li­ty Sys­tem Gui­dance”. Sin­ce 2008, it has been an ele­ment of the QMS ba­sed on the ICH gui­de­line Q10 Phar­maceu­ti­cal Qua­li­ty Sys­tems. In the fur­ther pro­cess, in 2011 this gui­de­line was in­cor­po­ra­ted into the new­ly ad­ded 3. Part of the EU GMP Gui­de adopted.

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EU GMP Guideline Annex 11

De­fi­ni­ti­on of the term (“What is the EU GMP Gui­dance An­nex-11?”) An­nex-11 of the EU GMP Gui­de­line is spe­ci­fic to com­pu­te­ri­zed sys­tems and elec­tro­nic records.


De­fi­ni­ti­on of the term (“What is a spe­ci­fi­ca­ti­on?”)  A spe­ci­fi­ca­ti­on con­ta­ins a spe­ci­fied de­scrip­ti­on by the con­trac­tor of how they in­tends to sol­ve the contracting