Deviation Control

Deviation Management software

»Deviation Control«

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Illustration of a notebook on which the QM-workflows of d.velop Life Sciences are mapped, Complaint, Deviation Control, CAPA, Change Control
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Con­trol your pro­duc­tion-re­la­ted QM pro­ces­ses such as de­via­ti­on con­trol 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.

How can you benefit from the Deviation Control software solution?

Data integrity 

De­via­ti­on re­ports are no lon­ger lost be­cau­se they are stored elec­tro­ni­cal­ly from the be­gin­ning. You also pro­tect your data from un­wan­ted in­ter­fe­rence of un­aut­ho­ri­zed users and from de­st­ruc­ti­ve forces. 

Process safety 

Af­ter each step, the work­flow sys­tem en­su­res that the de­via­ti­on is for­war­ded to the per­son in char­ge. 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. 

Individual configuration 

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

Constant availability 

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

Traceability 

De­via­ti­on re­ports can be lin­ked to other mo­du­les such as Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tions (CAPA) and Chan­ge Ma­nage­ment (CC). Thus a trace­ab­le chain of in­ter­re­la­ted in­di­vi­du­al pro­ces­ses is created. 

More efficient process runtimes 

Our cus­to­mers achie­ve si­gni­fi­cant­ly lower pro­cess run­ti­mes when using the di­gi­tal so­lu­ti­on for de­via­ti­on management. 

Transparency 

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

Central information platform 

Use the d.3ecm sys­tem as your cen­tral in­for­ma­ti­on plat­form on which you can re­trie­ve all your data on short notice. 

Reports 

Crea­te re­ports and sta­tis­tics about your de­via­ti­ons, e.g. as sup­port for your PQR. 

Some features of Deviation Management
  • Au­to­ma­tic PDF crea­ti­on and sto­rage of the form in the eDMS af­ter each step
  • Au­to­ma­tic clas­si­fi­ca­ti­on of the de­via­ti­on ba­sed on the me­ta­da­ta en­t­e­red in the form
  • Re­fe­ren­cing mas­ter data from your ERP system
  • Ad­ding do­cu­ments, such as di­gi­tal pho­tos, to your DC form
  • In­itia­ti­on of the in­di­vi­du­al tasks for the fur­ther pro­ces­sing of the workflow
  • Es­ca­la­ti­on messages both wi­t­hin the sys­tem and by e‑mail
  • In­te­gra­ted ab­sence management

Our Deviation Control process complies with the following regulations

We would like to present you some features already
Illustration of a notebook on which the QM-workflows of d.velop Life Sciences are mapped, Complaint, Deviation Control, CAPA, Change Control
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 | de­via­ti­on control

What is a De­via­ti­on Con­trol pro­cess?
The pur­po­se of the De­via­ti­on Con­trol pro­cess is to en­su­re that pro­ducts, pro­ces­ses, at­tach­ments and do­cu­ments that do not com­ply with the de­fi­ned qua­li­ty spe­ci­fi­ca­ti­ons are iden­ti­fied, eva­lua­ted and sub­jec­ted to a de­cisi­on on how to pro­ceed, and that the mea­su­res ta­ken are im­ple­men­ted. Af­fec­ted are pro­ducts and pro­ces­ses, ma­chi­nes and sys­tems that show a de­via­ti­on or mal­func­tion as well as de­via­ti­ons from re­gu­la­ti­ons, es­tab­lis­hed pro­ce­du­res and spe­ci­fi­ca­ti­ons that may have an im­pact on pro­duct quality.

The scope of ap­p­li­ca­ti­on concerns

  • Pro­duc­tion
  • Qua­li­ty control
  • Qua­li­ty assurance
  • QM Of­fi­cer
  • Qua­li­fied per­son (QP)
  • Ga­le­nics
Au­dit Trail

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

Form

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. Cau­se de­ter­mi­na­ti­on, 3. Risk con­si­de­ra­ti­on, 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
The re­cord­ing of a de­via­ti­on can be done by any em­ployee. Af­ter the re­le­vant data has been en­t­e­red by an em­ployee, the per­son who will pro­cess the cau­ses is de­ter­mi­ned au­to­ma­ti­cal­ly or can be selec­ted ma­nu­al­ly, de­pen­ding on the con­fi­gu­ra­ti­on . For ex­amp­le, the pro­cess can be sent to the head of the or­ga­niz­a­tio­nal unit (e.g. de­part­ment head). If, for ex­amp­le, the em­ployee is the head of the or­ga­niz­a­tio­nal unit, he or she is au­to­ma­ti­cal­ly the re­ci­pi­ent of the cau­se de­ter­mi­na­ti­on pro­cess step.

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. 

To the Live-WebCast

33 Good reasons for a cooperation with d.velop LS

You are 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 as well as other ge­ne­ral re­a­sons that dis­tin­guish us. 

To the reasons
Frequently asked questions (FAQs) about Deviation Control
When working on a pro­cess step, only this step can be pro­ces­sed, but the other pro­cess steps are still visible.
In the work­flow ad­mi­nis­tra­ti­on, you can con­fi­gu­re the na­mes of the pro­cess steps, field na­mes and datasets.
The De­via­ti­on Con­trol 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 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.
The es­sen­ti­al data of a De­via­ti­on Con­trol is trans­fer­red to the at­tri­bu­tes of the data re­cord. This al­lows you to se­arch and ana­ly­ze the De­via­ti­on Con­trols you have crea­ted. The ana­ly­ses can be ex­por­ted as PDF, EXCEL or WORD documents.
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.
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.
Ha­ving en­t­e­red a mea­su­re, you can save it as a tem­pla­te in the mea­su­re ta­ble. The tem­pla­tes are avail­ab­le for in­ser­ti­on in a De­via­ti­on Con­trol. The due date for the mea­su­re is cal­cu­la­ted ba­sed on the du­ra­ti­on en­t­e­red in the template.
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.
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 De­via­ti­on Con­trol un­der ‘At­tach­ments’ by all pro­cess par­ti­ci­pants. You can con­fi­gu­re which file ty­pes can be saved as at­tach­ments and how lar­ge the files can be.

Customer review on the Deviation Management

to the re­fe­rence overview

“We have been a cus­to­mer from the very be­gin­ning and d.velop Life Sci­en­ces sup­ports us re­li­ab­ly and sus­tainab­ly with their pro­ducts and thus hel­ps us to fur­ther de­ve­lop our QMS and to im­ple­ment elec­tro­nic so­lu­ti­ons / work­flows com­ply­ing with the re­qui­re­ments for data integrity.”

Sil­ke SchwiertzHead of QM/QA/QP (MEDICE Arz­nei­mit­tel Püt­ter GmbH & Co. KG)
Silke Schwiertz

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