Document Control

For the ad­mi­nis­tra­ti­on of QM do­cu­ments, the d.3 life sci­ence cli­ent can ma­na­ge the three do­cu­ment ca­te­go­ries ‘QM ma­nu­al, pro­cess in­st­ruc­tion and work in­st­ruc­tion’. The­se three do­cu­ment ca­te­go­ries show dif­fe­rent hier­ar­chi­cal le­vels of the QM do­cu­men­ta­ti­on. The QM ma­nu­al in­clu­des ge­ne­ral do­cu­ments like for ex­amp­le po­li­ci­es. For a more de­tail­ed de­scrip­ti­on of pro­cess in­st­ruc­tions, the QM ma­nu­al re­fers to the two hier­ar­chi­cal le­vels below.

The do­cu­ment cir­cu­la­ti­ons (e.g. re­view, ap­pro­val, re­lease, trai­ning, en­act­ment) can be fle­xi­b­ly con­fi­gu­red and ad­ap­ted to the re­qui­re­ments of the com­pa­ny. The cir­cu­la­ti­on is lin­ked to the do­cu­ment tem­pla­te, so a dif­fe­rent cir­cu­la­ti­on could be de­fi­ned for each template.

For the in­di­vi­du­al steps, you can de­ter­mi­ne whe­ther and which em­ployees and/or em­ployee pro­files can be selec­ted. You can de­ter­mi­ne whe­ther a mi­ni­mum or ma­xi­mum num­ber of peop­le are in­vol­ved in a step and spe­ci­fy a spe­ci­fic person/profile or make it mandatory.

The en­act­ment is al­ways the last step in a do­cu­ment cir­cu­la­ti­on and is usual­ly per­for­med au­to­ma­ti­cal­ly at the end of the sche­du­led trai­ning pha­se. It is howe­ver also pos­si­ble to per­form the en­act­ment manually.

In a do­cu­ment cir­cu­la­ti­on you can de­ci­de if you want to send a task for a pe­rio­dic re­view. If a pe­rio­dic check is plan­ned, the re­lea­ser re­cei­ves a pro­po­sed date ba­sed on the con­fi­gu­ra­ti­on (e.g. 2 ye­ars af­ter the en­act­ment) and a task for the pe­rio­dic re­view is sent with the ap­pro­pria­te lead time.

The task for the pe­rio­dic re­view can be sent to dif­fe­rent per­sons or ac­ti­vi­ty pro­files (e.g. ve­ri­fier, ap­pro­ver, releaser).

In­de­pendent­ly of the ad­di­tio­nal func­tions in ‘Em­ployee Qua­li­fi­ca­ti­on Ma­nage­ment’, you can de­fi­ne a do­cu­ment dis­tri­bu­ti­on list, on the ba­sis of which the ‘Bin­ding for list’ is crea­ted for a do­cu­ment. If do­cu­ment dis­tri­bu­ti­on is used, a first dis­tri­bu­ti­on list is spe­ci­fied in the do­cu­ment cir­cu­la­ti­on. With the first dis­tri­bu­ti­on list you select tho­se users who, af­ter re­lease of the do­cu­ment, will re­cei­ve the task for the read-and-un­ders­tood trai­ning. In con­nec­tion with the pro­ces­sing of this task, a sub-dis­tri­bu­ti­on op­ti­on is avail­ab­le. The em­ployee can dis­tri­bu­te the do­cu­ment to other em­ployees in con­nec­tion with the read-and-un­ders­tood training.