Con­trol your pro­duc­tion-re­la­ted QM pro­ces­ses such as chan­ge con­trols (CC) 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 do you benefit from the Change Control software?

Consideration of specifications 

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

Constant availability 

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

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 for your colleagues. 

Process safety 

The work­flow sys­tem en­su­res that the de­via­ti­on no­ti­fi­ca­ti­on is for­war­ded to the re­spec­ti­ve sub­ject mat­ter ex­pert af­ter each step. The es­ca­la­ti­on sys­tem ta­kes ef­fect in case of mis­sed deadlines. 

Reducing process costs 

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

Linking to other processes 

Chan­ge con­trols can be in­itia­ted, for ex­amp­le, from de­via­ti­on re­ports (De­via­ti­on Con­trol) or Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tions (CA­PAs).

Transparency 

Every aut­ho­ri­zed em­ployee sees the cur­rent sta­tus of all CC pro­ces­ses – 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 at short notice. 

Reports 

Crea­te re­ports and sta­tis­tics about your CCs 

Some features of Change Control 

Regulations fulfilled by the Change Control process

Would you like a live webcast of 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 (Com­p­laints), de­via­ti­on re­ports (De­via­ti­on Con­trol), Cor­rec­ti­ve And Pre­ven­ti­ve Ac­tions (CAPA) or chan­ge con­trols (Chan­ge Con­trol) with our di­gi­tal workflows

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.

Frequently asked questions (FAQs) about Change Control

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 Chan­ge Con­trol un­der ‘At­tach­ments’ for all pro­cess par­ti­ci­pants. You can con­fi­gu­re which file ty­pes can be saved as at­tach­ments and how lar­ge the files can be.
In the work­flow ad­mi­nis­tra­ti­on, you can con­fi­gu­re the na­mes of the pro­cess steps, field na­mes and datasets.
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.
The es­sen­ti­al data of a Chan­ge Con­trol is trans­fer­red to the at­tri­bu­tes of the data re­cord. You can use this to se­arch and crea­te eva­lua­tions of the Chan­ge Con­trols you have crea­ted. The ana­ly­ses can be ex­por­ted as PDF, EXCEL or WORD documents.
Ha­ving en­t­e­red a mea­su­re, you can save it as a tem­pla­te in the mea­su­re ta­ble. The tem­pla­tes are avail­ab­le for in­ser­ti­on in a Chan­ge Con­trol. The due date for the mea­su­re is cal­cu­la­ted ba­sed on the du­ra­ti­on en­t­e­red in the template.
Chan­ge Ma­nage­ment / Chan­ge Con­trol (CC) is a for­mal pro­cess wi­t­hin a qua­li­ty ma­nage­ment sys­tem. This aims is to en­su­re that all chan­ges to a pro­duct or pro­cess are car­ri­ed out in a con­trol­led and coor­di­na­ted man­ner and that the qua­li­ty of the pro­duct is main­tai­ned de­s­pi­te the change.

The equip­ment in the GMP clean­rooms must be qua­li­fied and the pro­ces­ses used must be va­li­da­ted. This me­ans that it is de­fi­ned and do­cu­men­ted in ad­van­ce which equip­ment is used in the ma­nu­fac­tu­re of a pro­duct, how the pro­cess pa­ra­me­ters are to be set, which in­gre­dients are re­qui­red, and much more. For ex­amp­le, chan­ges can be made to de­vices or even processes:

  • The sys­tem pa­ra­me­ters must be changed.
  • Parts or com­pon­ents of the plant must be renewed.
  • Chan­ges were ap­p­lied to in­gre­dients or quantities.
  • Chan­ges were ap­p­lied in clea­ning and tes­ting procedures.
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. Can­cel­ling is only al­lowd for the coor­di­na­tor of the process.
In all pro­cess steps that fol­low the in­itia­ti­on, you can for­ward the pro­cess step to ano­t­her per­son. The aut­ho­riz­a­ti­on of the re­ci­pi­ent is che­cked du­ring selection.
When edi­t­ing a pro­cess step, only this step can be edi­ted, but the other pro­cess steps are visible.
The chan­ge con­trol pro­cess flow has been struc­tu­red in ac­cordance with the GxP re­gu­la­ti­ons and crea­ted in con­sul­ta­ti­on with QM ex­perts. With re­fer­ehn­ce to 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 phar­maceu­ti­cal in­dus­try, but also in me­di­ci­ne, the qua­li­fi­ca­ti­on is a pre­re­qui­si­te for a li­cen­se to ma­nu­fac­tu­re. Si­gni­fi­cant chan­ges to qua­li­fied equip­ment al­ways re­sult in sub­se­quent re-qua­li­fi­ca­ti­on. Tho­se re­spon­si­ble must de­ci­de whe­ther chan­ges are ne­cessa­ry ba­sed on a risk ana­ly­sis. In ad­di­ti­on, the ques­ti­on must be an­s­we­red as to how the chan­ge af­fects the qua­li­ty of the pro­duct and which qua­li­fi­ca­ti­on tests must be repeated.
Com­pli­an­ce with par­ti­al re­gu­la­to­ry re­qui­re­ments is sim­pli­fied or made pos­si­ble in the first place, and the cor­re­spon­ding risks are mi­ni­mi­zed. Chan­ge pro­ces­ses are stan­dar­di­zed and trace­ab­le. Do­cu­men­ta­ti­on re­qui­re­ments can be met by de­fault. Em­ployees at dif­fe­rent sites can work on the same chan­ge wi­thout ha­ving to wait for do­cu­ments by mail.

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The Chan­ge Con­trol so­lu­ti­on is a com­po­nent 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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Document Control

Whe­ther work / pro­cess in­st­ruc­tions (SOPs), pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons or other ty­pes of do­cu­ments — you can crea­te, re­vi­se and sign them all di­gi­tal­ly with this module.

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Training Management

Ex­tend the “Do­cu­ment Con­trol” mo­du­le to ac­tively plan and re­cord the qua­li­fi­ca­ti­ons of your em­ployees with our trai­ning management.

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E‑learning

Use the new mo­du­le “E‑Learning” to train your em­ployees di­gi­tal­ly. Crea­te an e‑learning cour­se ac­cord­ing to your wis­hes using Mi­cro­soft Power­Point or in­te­gra­te exis­ting presentations.

Quick contact

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