Be it work/process in­st­ruc­tions (SOPs), pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons, ope­ra­ting in­st­ruc­tions, con­tracts or any other do­cu­ment ty­pes — you crea­te, re­vi­se and sign them all elec­tro­ni­cal­ly with our “Do­cu­ment Con­trol” mo­du­le. The do­cu­ment cir­cu­la­ti­on is de­ter­mi­ned by con­fi­gu­ra­ti­on. Dif­fe­rent (sin­gle or mul­ti­le­vel) do­cu­ment cir­cu­la­ti­ons can be stored for each do­cu­ment tem­pla­te. Thus it can be cu­sti­mi­zed to your needs and pro­ce­du­res. The sys­tem au­to­ma­ti­cal­ly as­signs cor­re­spon­ding “Pe­rio­dic Re­view” tasks to the ap­pro­pria­te em­ployees. The in­te­gra­ted re­min­der and es­ca­la­ti­on ma­nage­ment sys­tem si­gnals when dead­lines and tasks are ex­cee­ded. The par­ti­ci­pa­ti­on in the au­to­ma­tic do­cu­ment cir­cu­la­ti­on is con­fir­med by the elec­tro­nic and GxP-com­pli­ant si­gna­tu­re. In­te­gra­ted au­dit trails for every do­cu­ment in­cre­a­se traceability.

How do you benefit from the Document Control software?

Digital management

Di­gi­tal­ly ma­na­ge your spe­ci­fi­ca­ti­on do­cu­ments (e.g. work and pro­cess in­st­ruc­tions, test spe­ci­fi­ca­ti­ons, hy­gie­ne plans), forms, con­tracts and other do­cu­ment types.

Completion at the touch of a button

Hand­le the dis­tri­bu­ti­on of do­cu­ments and the si­gna­tu­re cir­cu­la­ti­on di­gi­tal­ly at the push of a but­ton and fo­cus on your core business.

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. 

Minimization of process runtimes

Save time by mi­ni­mi­zing pro­cess run­ti­mes for the crea­ti­on, re­vi­si­on, re­lease and dis­tri­bu­ti­on of your spe­ci­fi­ca­ti­on documents.

Reduction of resources

Re­du­ce un­ne­cessa­ry prin­touts and pa­per on your desk. This spa­res the en­vi­ron­ment, your ner­ves and your money.

Central information platform

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

Constant availability

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

Some features of the Document Control

  • Crea­ti­on of regulated/controlled do­cu­ments wi­t­hin the sys­tem ba­sed on ap­pro­ved templates
  • The tem­pla­tes may also be con­trol­led documents.
  • Ma­nage­ment of spe­ci­fi­ca­ti­ons and form sheets
  • Di­gi­tal do­cu­ment si­gna­tu­re using in­te­gra­ted GxP-com­pli­ant si­gna­tu­re — pu­re­ly software-based
  • Full-text se­arch ba­sed on do­cu­ment con­tent and do­cu­ment at­tri­bu­tes (meta data)
  • In­di­vi­du­al and dy­na­mic for­ced watermark
  • Easy crea­ti­on of re­port lists
  • Con­trol­led and log­ged printing
  • Com­pa­ri­son of do­cu­ment ver­si­ons and vi­sua­liz­a­ti­on of differences
  • In­te­gra­ted ar­chi­ving on the ba­sis of d.3ecm system
  • Win­dows and Web-Frontend
  • Pe­rio­dic review

Which regulations must be observed for controlled documents?

Would you like a live webcast of our software?

Get a live in­sight into the pos­si­bi­li­ties of the Do­cu­ment Con­trol in just 45 mi­nu­tes with a sam­ple use case. Learn how you can elec­tro­ni­cal­ly crea­te, re­vi­se and sign your work/process in­st­ruc­tions (SOPs), pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons, ope­ra­ting in­st­ruc­tions, con­tracts or any other do­cu­ment ty­pes by me­ans of the so­lu­ti­ons of d.velop Life Sciences.

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 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.

A do­cu­ment is as­si­gned to an aut­hor who is re­ser­ved for edi­t­ing. Howe­ver, the aut­hor­s­hip can be trans­fer­red to ano­t­her em­ployee so that he or she can add fur­ther con­tent if necessary.

Using a num­be­ring sche­me a uni­que num­ber can be as­si­gned to every do­cu­ment in the d.3 life sci­ence cli­ent. Hier­ar­chi­cal num­be­ring is also avail­ab­le here, which has an ef­fect on the re­lease pro­ces­ses. For ex­amp­le, an at­tach­ment crea­ted with a hier­ar­chi­cal num­be­ring sys­tem  can only be re­leased if the su­per­or­di­na­te do­cu­ment is released.

One or more fur­ther ap­p­li­ca­ble do­cu­ments and/or at­tach­ments can be as­si­gned to a con­trol­led do­cu­ment. They are lis­ted in the document’s pro­per­ties and in the pre­view and can also be ac­ces­sed di­rect­ly here.

You can con­fi­gu­re that the aut­hor of a do­cu­ment re­cei­ves a note when a do­cu­ment or at­tach­ment is re­leased in a new version.

With ap­pro­pria­te aut­ho­riz­a­ti­on, an em­ployee can print con­trol­led do­cu­ments. Du­ring con­trol­led prin­ting, he or she selects the extent to which the do­cu­ment should be prin­ted (ad­di­tio­nal pa­ges with in­for­ma­ti­on on the au­dit trail, elec­tro­nic si­gna­tures, etc.). He or she must spe­ci­fy a re­a­son for prin­ting and the prin­tout is log­ged in the properties.

If the prin­tout is re­por­ted as re­tur­ned / de­s­troy­ed, this is no­ted in the sys­tem using the func­tion ‘Prin­tout confirmation’.

An elec­tro­nic si­gna­tu­re is im­ple­men­ted for all ac­tions re­qui­ring si­gna­tures (do­cu­ment cir­cu­la­ti­on, read-and-un­ders­tood tasks, etc.). It meets the re­qui­re­ments of the FDA and the GMP gui­de­li­nes and sub­sti­tu­tes for the per­so­nal si­gna­tu­re on a prin­ted do­cu­ment. This func­tion en­ab­les re­spon­si­ble per­sons to pro­vi­de the ne­cessa­ry si­gna­tures even at a di­stance. Each si­gna­tu­re is re­cor­ded in the au­dit trail and prin­ted on an ad­di­tio­nal page with the document.

Con­trol­led do­cu­ments are ma­na­ged in a mi­nor and ma­jor ver­sio­ning. The­re may be mul­ti­ple edi­t­ing ver­si­ons if  has re­jec­ted the check/approval/release in the do­cu­ment cir­cu­la­ti­on. The aut­hor crea­tes a new pro­ces­sing ver­si­on and re­starts the si­gna­tu­re cir­cu­la­ti­on. All ver­si­ons of a con­trol­led do­cu­ment can be view­ed by aut­ho­ri­zed users. A di­rect do­cu­ment com­pa­ri­son of two ver­si­ons is also avail­ab­le here.

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