Change Control

Change Management software

»Change 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
Get con­sul­tancy now

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.

What benefits does the Change Control software offer you?

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 of your colleagues. 

Process safety 

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

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. 

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 on short notice. 

Reports 

Crea­te re­ports and sta­tis­tics about your chan­ge controls. 

Some features of Change Management 
  • Clas­si­fi­ca­ti­on of the Chan­ge Con­trol pro­ces­ses ac­cord­ing to types
  • Eva­lua­ti­on of a CC ac­cord­ing to ap­pro­val, re­gis­tra­ti­on or GMP re­le­van­ce with con­se­quent de­aling in the dy­na­mic CC form
  • Dis­tri­bu­tor for plan­ning, pro­ces­sing and ap­pro­ving measures
  • Op­tio­nal re­turn in process
  • Log­ging of ac­ti­vi­ties in au­dit trail
  • Par­al­lel and se­ri­al sen­ding of tasks
  • Au­to­ma­tic PDF crea­ti­on and sto­rage of the form in the eDMS af­ter each step
  • Re­fe­ren­cing mas­ter data from your ERP system
  • Ad­ding do­cu­ments, such as di­gi­tal pho­tos, to your CC 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
  • In­itia­ti­on of a do­cu­ment chan­ge re­quest for a con­trol­led document

Regulations fulfilled by the Change Control process

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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
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 | chan­ge control

What is a Chan­ge Con­trol pro­cess?
The Chan­ge Con­trol pro­cess is used to en­su­re that chan­ges af­fec­ting pro­ducts, pro­ces­ses and sys­tems are car­ri­ed out in con­for­mi­ty with re­gu­la­to­ry and in­ter­nal spe­ci­fi­ca­ti­ons. The aim of this pro­cess is to pro­vi­de a sys­te­ma­tic, trace­ab­le chan­ges management.

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 & ca­te­go­riz­a­ti­on, 2. Eva­lua­ti­on of re­le­van­ce for ap­pro­val, 3. Eva­lua­ti­on of re­le­van­ce for re­gis­tra­ti­on, 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 in­itia­ti­on of the Chan­ge Con­trol is done by the pro­cess re­spon­si­ble of the con­cer­ned de­part­ment. He or she re­cords the re­le­vant data for Chan­ge Con­trol. The pro­cess is then for­war­ded to the ap­poin­ted Chan­ge Con­trol responsible.

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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. 

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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 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 the Chan­ge 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.
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. This al­lows you to se­arch and ana­ly­ze 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. The aim 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 also processes:

  • The sys­tem pa­ra­me­ters must be changed.
  • Parts or com­pon­ents of the plant must be renewed.
  • In­gre­dients or quan­ti­ties changed.
  • Clea­ning or tes­ting pro­ce­du­res changed.
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.
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.
When working on a pro­cess step, only this step can be pro­ces­sed, but the other pro­cess steps are still visible.
The Chan­ge 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 the phar­maceu­ti­cal in­dus­try, but also in me­di­ci­ne, the qua­li­fi­ca­ti­on is a pre­re­qui­si­te for a ma­nu­fac­tu­ring li­cen­se. 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.

Customer review on the Change Management

to the re­fe­rence overview

“d.velop Life Sci­en­ces GmbH has sup­por­ted us in the chan­geo­ver to a new elec­tro­nic qua­li­ty ma­nage­ment sys­tem in re­cord time with pro­fes­sio­na­lism and ex­per­ti­se. In the pro­cess, six in­de­pen­dent do­cu­ment ma­nage­ment sys­tems were trans­fer­red to a har­mo­ni­zed cen­tral d.3 eQMS. The sup­port for the im­ple­men­ta­ti­on of va­li­da­ti­on re­qui­re­ments for com­pu­te­ri­zed sys­tems ac­cord­ing to GxP and ISO re­qui­re­ments is ex­cel­lent. The mo­du­les “Do­cu­ment Con­trol”, “Em­ployee Qua­li­fi­ca­ti­on”, “De­via­ti­on Con­trol”, “CAPA” and “Chan­ge Con­trol” are used world­wi­de at SCHOTT AG and by in­te­gra­ting fur­ther tools in qua­li­ty ma­nage­ment the port­fo­lio could be im­pro­ved bey­ond do­cu­ment con­trol. We have struck up po­si­ti­ve ex­pe­ri­en­ces from the col­la­bo­ra­ti­on and will con­ti­nue the good part­ner coope­ra­ti­on with fur­ther topics.”

Chris­ti­ne Stru­belHead of Ma­nage­ment Sys­tems Qua­li­ty & EHS (SCHOTT AG)
Christine Strubel

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