Complaint Management software


Software for your complaint management

Con­trol your pro­duc­tion-re­la­ted QM pro­ces­ses such as com­p­laints with our di­gi­tal work­flows. Our in­te­gra­ted so­lu­ti­ons ma­na­ge your pre­vious­ly pa­per-bound pro­cess from cap­tu­re to com­ple­ti­on com­ple­te­ly di­gi­tal­ly. The work­flow sys­tem au­to­ma­ti­cal­ly for­wards the di­gi­tal form to the next in­stance; if dead­lines are ex­cee­ded, the re­min­der and es­ca­la­ti­on ma­nage­ment ta­kes ef­fect. Of cour­se, an ab­sence ma­nage­ment is also in­clu­ded for the task routing.

Illustration of a notebook on which the QM-workflows of d.velop Life Sciences are displayed

What benefits does the Complaint software offer you?

Consideration of specifications 

Chan­ges to pro­ducts, pro­ces­ses or sys­tems are car­ri­ed out in ac­cordance with re­gu­la­to­ry and in­ter­nal specifications. 


Every aut­ho­ri­zed em­ployee sees the cur­rent sta­tus of all com­p­laint pro­ces­ses – even if he or she is not in­vol­ved in the process. 

Linking to other processes 

From com­p­laints, cor­re­spon­ding De­via­ti­on Con­trols (DCs), Cor­rec­ti­ve And Pre­ven­ti­ve Ac­tions (CA­PAs) and Chan­ge Con­trols (CCs) can also be generated. 

Individual configuration 

Let the mo­du­les be con­fi­gu­red ac­cord­ing to your wis­hes and pre­fe­ren­ces to fa­ci­li­ta­te the on­boar­ding trai­ning for your colleagues. 

Central information platform 

Use d.velop do­cu­ments (form­er­ly d.3ecm) as your cen­tral in­for­ma­ti­on plat­form on which you can re­trie­ve all your data at short notice. 

Reduction of process costs 

The cos­ts of ad­mi­nis­tra­ti­on as well as the run­ti­mes of the pro­ces­ses are re­du­ced, the qua­li­ty of the re­sults is increased. 

Process safety 

Af­ter each step, the work­flow sys­tem en­su­res that the com­p­laint is for­war­ded to the per­son in char­ge. The es­ca­la­ti­on sys­tem ta­kes ef­fect in case of mis­sed dead­lines. The es­ca­la­ti­on sys­tem ta­kes ef­fect in case of mis­sed deadlines. 

Increased data security 

Pro­tect your data from un­wan­ted in­ter­fe­rence by un­aut­ho­ri­zed users and from de­st­ruc­ti­ve forces. 

Constant availability 

Ac­cess your data at any time. It does not mat­ter whe­re you are. 


Crea­te re­ports and sta­tis­tics about your complaints. 

Get to know our software better

Illustration of a notebook on which the QM-workflows of d.velop Life Sciences are displayed
PDF Do­cu­ment

The di­gi­tal forms are also con­ver­ted to a PDF/A in par­al­lel. This way, em­ployees who are not in­vol­ved in the pro­cess can also gain in­sight into the work­flow and the do­cu­ment can be shared with ex­ter­nal par­ties if required.

d.velop life sci­en­ces | complaint

What is the Com­p­laint Pro­cess?
The CP (Com­p­laint Pro­cess) al­lows drug safety/pharmacovigilance com­p­laints to be sys­te­ma­ti­cal­ly re­cor­ded and pro­ces­sed in con­for­mi­ty with re­gu­la­to­ry and in­ter­nal spe­ci­fi­ca­ti­ons. The aim of this pro­cess is to en­su­re an ef­fi­ci­ent, se­cu­re and le­gal­ly com­pli­ant pro­ce­du­re by me­ans of sys­te­ma­tic, trace­ab­le mea­su­re management.

Au­dit Trail

Every ac­tion in the pro­cess is au­to­ma­ti­cal­ly do­cu­men­ted by the sys­tem ac­cord­in­gly. In­te­gra­ted au­dit trail func­tions en­su­re high traceability.


The di­gi­tal form is fil­led out step by step and pro­vi­ded with the re­le­vant ent­ries and data. Fiel­ds with a blue back­ground are man­da­to­ry. Pre­de­fi­ned va­lue sets and drop-down func­tions make it easy for users to fill out the form.

Pro­cess Steps

Af­ter pro­ces­sing the in­di­vi­du­al steps (1. In­itia­ti­on, 2. In­iti­al as­sess­ment, 3. De­fi­ni­ti­on of mea­su­res, etc.), the work­flow sys­tem au­to­ma­ti­cal­ly sends tasks and messages to the re­spon­si­ble agents or work­flow par­ti­ci­pants. Once all steps have been pro­ces­sed, the work­flow is con­si­de­red complete.

1st Step: In­itia­ti­on
In this step, the in­itia­tor spe­ci­fies the ge­ne­ral data, the sen­der and the pro­duct con­cer­ned. If sti­pu­la­ted for the selec­ted pro­duct type, the step plan of­fi­cer will be involved.

Would you like a live insight into the software?

Get a live in­sight into the pos­si­bi­li­ties of the pro­duc­tion-re­la­ted QM pro­ces­ses in just 45 mi­nu­tes with a sam­ple use case. Learn how you can use the so­lu­ti­ons of d.velop Life Sci­en­ces to op­ti­mi­ze your pro­duc­tion-re­la­ted QM pro­ces­ses such as com­p­laints (Com­p­laint), de­via­ti­on re­ports (De­via­ti­on Con­trol), cor­rec­ti­ve and pre­ven­ti­ve ac­tions (CAPA) or chan­ge con­trols (Chan­ge Con­trol) with our di­gi­tal workflows.

Some features of Complaint Management

What regulations must be observed in the Complaint Process?

33 Good reasons for a cooperation with d.velop LS

You’re not con­vin­ced yet? Find out about 33 good re­a­sons spea­king for a coope­ra­ti­on with d.velop Life Sci­en­ces GmbH. We will show you re­a­sons from the provider’s point of view, from the soft­ware point of view and other ge­ne­ral re­a­sons that dis­tin­guish us. 

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Com­p­laint is a mo­du­le of the d.velop Life Sci­en­ces so­lu­ti­on suite. Each pro­duct is power­ful on its own, but when used tog­e­ther they are even better.

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Frequently asked questions (FAQs) about Complaint

The Com­p­laint pro­cess flow has been de­si­gned in ac­cordance with the GxP re­gu­la­ti­ons and crea­ted in con­sul­ta­ti­on with QM ex­perts. Against the back­ground of the va­li­da­ti­on do­cu­men­ta­ti­on, the pro­cess steps are the­re­fo­re man­da­to­ry. Howe­ver, each pro­cess step con­tains a ‘Cus­tom Pa­nel’, which can be used to dis­play fur­ther in­for­ma­ti­on or in­itia­te actions.

In the work­flow ad­mi­nis­tra­ti­on, you can con­fi­gu­re the na­mes of the pro­cess steps, field na­mes and datasets.

When working on a pro­cess step, only this step can be pro­ces­sed, but the other pro­cess steps are still visible.

The es­sen­ti­al data of a Com­p­laint is trans­fer­red to the at­tri­bu­tes of the data re­cord. This al­lows you to se­arch and ana­ly­ze the Com­p­laints you have crea­ted. The ana­ly­ses can be ex­por­ted as PDF, EXCEL or WORD documents.

In all pro­cess steps that fol­low the in­itia­ti­on, you can for­ward the pro­cess step to ano­t­her per­son. The recipient’s aut­ho­riz­a­ti­on is che­cked du­ring the selection.

Pro­duct de­fects af­fect cus­to­mer sa­tis­fac­tion and can also pose a risk to he­alth and safe­ty. Com­p­laint ma­nage­ment is the­re­fo­re a cen­tral ele­ment of qua­li­ty ma­nage­ment: Re­por­ted com­p­laints are sys­te­ma­ti­cal­ly re­cor­ded and pro­ces­sed. A com­p­laint ma­nage­ment soft­ware par­ti­al­ly au­to­ma­tes the ma­nage­ment pro­cess and hand­les com­p­laints ef­fi­ci­ent­ly. It also pro­vi­des a va­rie­ty of me­thods and tools to re­cord in­co­m­ing com­p­laints, iden­ti­fy their cau­ses, eli­mi­na­te them and pre­vent them in the fu­ture. This mi­ni­mi­zes the risk of re­pea­ting er­rors and re­du­ces the as­so­cia­ted cos­ts. The aim is to achie­ve a sus­tainab­le im­pro­ve­ment in pro­duct quality.

Com­p­laint en­ab­les the se­cu­re, struc­tu­red and ef­fi­ci­ent pro­ces­sing of com­p­laints using elec­tro­nic si­gna­tures and stan­dar­di­zed work­flows. This crea­tes trans­pa­ren­cy, do­cu­ments the de­cisi­ve pro­ces­sing steps and makes every com­p­laint trace­ab­le. In this way, pos­si­ble ir­re­gu­la­ri­ties can no lon­ger be over­loo­ked in the fu­ture. Ear­ly warning in­di­ca­tors and dif­fe­ren­tia­ted es­ca­la­ti­on me­cha­nisms are also pro­ving use­ful. Re­spon­si­ble par­ties are no­ti­fied ac­cord­ing to their role so that the com­p­laint pro­cess is con­ti­nuous­ly mo­ni­to­red. In ad­di­ti­on, work­flows can be fle­xi­b­ly ad­ap­ted to spe­ci­fic com­pa­ny sce­n­a­ri­os. This en­su­res com­pli­an­ce with ap­p­li­ca­ble in­dus­try stan­dards and re­gu­la­ti­ons, such as ISO 9001 or ISO 13485.

In con­trol­led en­vi­ron­ments, the role of com­p­laints is of par­ti­cu­lar im­por­t­ance. FDA re­gu­la­ti­ons and ISO stan­dards re­qui­re a for­mal com­p­laint ma­nage­ment sys­tem. Ef­fec­ti­ve com­p­laint ma­nage­ment is im­portant for in­forming su­per­vi­sors or re­gu­la­tors of qua­li­ty is­su­es. Con­trol­led com­pa­nies need to be able to re­sol­ve the­se is­su­es quickly.

In princip­le, a pro­cess step is com­ple­ted with an elec­tro­nic si­gna­tu­re and can no lon­ger be cor­rec­ted. With the func­tion ‘Step back’ the pro­cess can be re­tur­ned to a pre­vious pro­cess step. The user who has com­ple­ted this step re­cei­ves it again for edi­t­ing and the pro­cess con­ti­nues from this step. Any re­turn to a pre­vious step is re­cor­ded in the au­dit trail.

It can be con­fi­gu­red so that the pro­cess can be can­cel­led at any pro­cess step. For the can­cel­la­ti­on, it is re­qui­red to in­di­ca­te a re­a­son in a man­da­to­ry field. Only the coor­di­na­tor of the pro­cess is al­lo­wed to cancel.

If ad­di­tio­nal files are re­qui­red for a pro­cess, at­tach­ments can be uploa­ded in all pro­cess steps and lin­ked to the cur­rent pro­cess. The at­tach­ments are stored un­der a cor­re­spon­ding do­cu­ment type in the DMS and can be view­ed in the com­p­laint un­der ‘At­tach­ments’ by all pro­cess par­ti­ci­pants. You can con­fi­gu­re which file ty­pes can be saved as at­tach­ments and how lar­ge the files can be.

In the ad­mi­nis­tra­ti­on, time spe­ci­fi­ca­ti­ons can be en­t­e­red for each pro­cess step. Re­min­der messages are sent be­fo­re the pro­cess steps are due. The re­min­der mes­sa­ge is sent to the pro­ces­sor of the task, the coor­di­na­tor and the con­fi­gu­red group that is to be in­for­med about the re­min­der (for ex­amp­le, QA). A re­min­der is sent with the con­fi­gu­red subject.

Ha­ving en­t­e­red a mea­su­re, you can save it as a tem­pla­te in the mea­su­re ta­ble. The tem­pla­tes are avail­ab­le for in­ser­ti­on in a Com­p­laint. The due date for the mea­su­re is cal­cu­la­ted ba­sed on the du­ra­ti­on en­t­e­red in the template.

In com­bi­na­ti­on with the De­via­ti­on Con­trol, CAPA and Chan­ge Con­trol work­flows, the com­p­laint ma­nage­ment soft­ware “Com­p­laint” hand­les the en­t­i­re pro­blem re­so­lu­ti­on pro­cess, from re­por­ting to ef­fec­ti­ve­ness tes­ting to the com­p­laint com­ple­ti­on. For ex­amp­le, ap­pro­pria­te cor­rec­ti­ve or pre­ven­ti­ve ac­tions can be crea­ted di­rect­ly from iden­ti­fied de­fi­ci­en­ci­es. The Com­p­laint soft­ware thus si­gni­fi­cant­ly in­cre­a­ses the ef­fi­ci­en­cy of qua­li­ty-re­la­ted pro­ces­ses and con­tri­bu­tes to a si­gni­fi­cant re­duc­tion in the cos­ts of qua­li­ty incidents.

Wi­t­hin com­p­laint pro­ces­sing, an in­iti­al as­sess­ment of the si­tua­ti­on or case/problem can be map­ped by the company’s own em­ployees. In the fur­ther cour­se, mea­su­res can be de­fi­ned which con­se­quent­ly con­tri­bu­te to pro­blem sol­ving and thus to com­p­laint sti­mu­la­ti­on af­ter they have been pro­ces­sed. The­se are im­portant steps to lo­ca­te re­spon­si­bi­li­ties and de­cisi­ons and to avoid er­rors in the pro­cess chain. Ul­ti­mate­ly, the abi­li­ty to ask ques­ti­ons di­gi­tal­ly wi­t­hin the pro­cess and re­cei­ve feed­back in a short time also pro­ves to be a gre­at op­por­tu­ni­ty for companies.

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