Deviation Control — efficient solutions of Digital Life Sciences GmbH

The in­te­gra­ted soft­ware so­lu­ti­ons by Di­gi­tal Life Sci­en­ces GmbH of­fer you the di­gi­tal im­ple­men­ta­ti­on of de­via­ti­ons, as well as cor­rec­ti­ve ac­tions and ch­an­ges. The form­er­ly pa­per-ba­sed pro­cess is now com­ple­te­ly elec­tro­nic for ef­fi­ci­ent de­via­ti­on ma­nage­ment. Learn more about our soft­ware so­lu­ti­on for your de­via­ti­on management.

What is deviation management (Deviation Control)?

De­via­ti­on management/deviation con­trol de­scri­bes the pro­cess of iden­ti­fy­ing, ana­ly­zing and eli­mi­na­ting de­via­ti­on sta­tes. This in­cludes the log­ging and clas­si­fi­ca­ti­on of er­rors and de­via­ti­ons and their con­trol. It is an im­portant part of qua­li­ty ma­nage­ment.

Definition and overview

De­via­ti­on con­trol is about the de­tec­tion and re­cor­ding of un­ex­pec­ted events or an­oma­lies in the sys­tem or pro­cess flow. De­via­ti­on con­trol also in­cludes the ana­ly­sis and clas­si­fi­ca­ti­on of de­via­ti­ons. This is fol­lo­wed by the pro­ces­sing and cor­rec­tion of the er­rors or the crea­ti­on of pre­ven­ti­ve me­a­su­res. Suf­fi­ci­ent do­cu­men­ta­ti­on of the er­rors is one of the es­sen­ti­al pre­con­di­ti­ons for cor­rec­ting the deviations.

Er­rors can oc­cur in num­e­rous pro­ces­ses and sys­tems. Not all of the­se er­rors can be cor­rec­ted im­me­dia­te­ly, which is why it is also im­portant to esti­ma­te the risk of an er­ror re­mai­ning in the sys­tem. The De­via­ti­on Con­trol de­ri­ves cer­tain me­a­su­res for cor­rec­tion and eli­mi­na­ti­on of the er­rors iden­ti­fied in the processes.

The main ob­jec­ti­ve of de­via­ti­on ma­nage­ment is to de­fi­ne uni­form coun­ter­me­a­su­res. In this way, a ba­sis is crea­ted for cor­rec­ting the er­rors and their im­pacts. Pro­ble­ma­tic si­tua­tions must be iden­ti­fied at an ear­ly stage so that ap­pro­pria­te coun­ter­me­a­su­res can be de­fi­ned and ta­ken in good time.

Deviation, correction and change

Clo­se­ly lin­ked to de­via­ti­on ma­nage­ment are CAPA (Cor­rec­ti­ve And Pre­ven­ti­ve Ac­tions) or pre­ven­ti­ve me­a­su­res and Ch­an­ge Con­trol (ch­an­ge ma­nage­ment). The lat­ter are me­a­su­res ai­med at en­su­ring that com­pa­ra­ble de­via­ti­ons will not oc­cur in the future.

If de­via­ti­ons oc­cur, a de­via­ti­on re­port must be pre­pared. Ho­we­ver, this does not have to be an ac­tu­al er­ror. It may also be that the iden­ti­fied de­via­ti­on is re­la­ted to the test or pro­duc­tion en­vi­ron­ment, or that in­suf­fi­ci­ent data is available du­ring testing.

In the nar­rower sen­se, de­via­ti­ons in­clude tech­ni­cal er­rors, pa­ra­me­ter­iza­ti­on er­rors or pro­gramming that does not cor­re­spond to the con­cept. User er­rors or pro­blems in the tech­ni­cal ques­ti­on are not con­side­red de­via­ti­ons in the sen­se of De­via­ti­on Con­trol. An er­ror con­di­ti­on then cor­re­sponds to a task in De­via­ti­on Con­trol if the er­ror im­pact can be eli­mi­na­ted by me­a­su­res such as CAPA or Ch­an­ge Control.

For a clear iden­ti­fi­ca­ti­on of the er­ror it is im­portant to do­cu­ment all re­le­vant data mo­du­les and in­for­ma­ti­on exact­ly. This in­cludes, for ex­am­p­le, the su­spec­ted cau­se, re­pro­du­ci­bi­li­ty of the er­ror or time of its oc­cur­rence. It is of­ten pos­si­ble to de­ter­mi­ne the se­ve­ri­ty of the er­ror by me­ans of cer­tain cha­rac­te­ristics. It is also pos­si­ble to as­sess the pos­si­ble im­pacts of the de­via­ti­on in the me­di­um and long term. De­via­ti­on ma­nage­ment the­r­e­fo­re de­fi­nes the work­flow over the com­ple­te life cy­cle of an error.

Wi­thin the scope of ch­an­ge ma­nage­ment, the aim is to iden­ti­fy the im­pact of er­rors as ear­ly as pos­si­ble. The ear­lier cor­rec­ti­ve ac­tions are ta­ken, the smal­ler the con­se­quen­ti­al er­rors and pos­si­ble cos­ts. The me­a­su­res re­sul­ting from the ana­ly­ses can re­la­te both to the di­rect eli­mi­na­ti­on of the de­via­ti­on and to the con­trol and con­ti­nuous im­pro­ve­ment of the pro­ces­ses, so that a re­pe­ti­ti­on of the er­rors be­co­mes unlikely.

Digital Life Sciences GmbH as a strong partner

The ran­ge of ser­vices of­fe­red by Di­gi­tal Life Sci­en­ces GmbH pro­vi­des in­te­gra­ted GxP-com­pli­ant so­lu­ti­ons for your qua­li­ty ma­nage­ment. They ran­ge from De­via­ti­on con­trol and CA­PAs to ch­an­ge no­ti­fi­ca­ti­ons and Ch­an­ge Con­trol. The en­ti­re pro­cess runs di­gi­tal­ly and spa­res you the need for pa­per-ba­sed measures.

De­via­ti­on ma­nage­ment is also an in­te­gral part of the ECM sys­tem by d.velop. The sys­tem, which was spe­ci­al­ly de­ve­lo­ped for the life sci­en­ces in­dus­try, con­ta­ins ty­pi­cal ECM func­tions and all re­le­vant tools for do­cu­ment-ori­en­ted pro­ces­ses. With the­se and other so­lu­ti­ons, d.velop is a powerful part­ner for num­e­rous cus­to­mers from the life sci­en­ces, phar­maceu­tics, me­di­cal tech­no­lo­gy, ser­vice sec­tor and steel industry.

You have fur­ther ques­ti­ons about our soft­ware so­lu­ti­ons? Plea­se cont­act us, be­cau­se we will be hap­py to ad­vi­se you.

Are you looking for a solution for your deviation processes?

Then take a look at our so­lu­ti­on now

Illustration of a notebook on which the QM-workflows of Digital Life Sciences are mapped, Complaint, Deviation Control, CAPA, Change Control