CHANGE MANAGEMENT SOFTWARE

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.

A ch­an­ge con­trol form is a cru­cial do­cu­ment in the con­text of ch­an­ge ma­nage­ment and con­ta­ins es­sen­ti­al in­for­ma­ti­on, in­clu­ding a de­tail­ed de­scrip­ti­on of the ch­an­ge, the un­der­ly­ing re­asons, the sec­tions af­fec­ted and the ne­ces­sa­ry ap­pr­ovals. It ser­ves as struc­tu­red do­cu­men­ta­ti­on in the ch­an­ge con­trol pro­cess and en­su­res that all re­le­vant ap­pr­ovals and checks are com­ple­ted be­fo­re the ch­an­ge is im­ple­men­ted in practice.

Alt­hough ch­an­ge con­trol and ch­an­ge ma­nage­ment are clo­se­ly lin­ked, they have dif­fe­rent fo­cu­ses that are of cru­cial im­portance in pro­duc­tion. Ch­an­ge Con­trol fo­cu­ses on the sys­te­ma­tic for­ma­liza­ti­on and do­cu­men­ta­ti­on of ch­an­ges. The aim is to en­su­re that all ch­an­ges are careful­ly eva­lua­ted and ap­pro­ved. This is done th­rough spe­ci­fic pro­ce­du­res and forms ai­med at en­su­ring con­sis­ten­cy and compliance.

Ch­an­ge ma­nage­ment is a com­pre­hen­si­ve con­cept that en­com­pas­ses the sys­te­ma­tic plan­ning, im­ple­men­ta­ti­on and mo­ni­to­ring of ch­an­ges in pro­ces­ses, tech­no­lo­gies and or­ga­niza­tio­nal struc­tures. In pro­duc­tion, ch­an­ge ma­nage­ment plays a de­cisi­ve role in the in­tro­duc­tion of new tech­no­lo­gies and soft­ware sys­tems. It en­su­res that all em­ployees are ade­qua­te­ly pre­pared and trai­ned to en­su­re a smooth tran­si­ti­on and op­ti­mi­ze the ef­fi­ci­en­cy of processes.

Ch­an­ge con­trol and ch­an­ge ma­nage­ment tog­e­ther form a com­pre­hen­si­ve frame­work for ch­an­ge ma­nage­ment in pro­duc­tion. Ch­an­ge Con­trol en­su­res struc­tu­ral in­te­gri­ty and com­pli­ance with re­gu­la­to­ry re­qui­re­ments, while ch­an­ge ma­nage­ment pro­mo­tes the smooth and ef­fi­ci­ent im­ple­men­ta­ti­on of changes.