Document Control

Document Control software

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Illustration of a notebook on which the document control of d.velop Life Sciences is displayed
Get con­sul­tancy now

Whe­ther work / pro­cess in­st­ruc­tions (SOPs), pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons, ope­ra­ting in­st­ruc­tions, con­tracts or any other ty­pes of do­cu­ments — you can crea­te, re­vi­se and sign them all elec­tro­ni­cal­ly with our “Do­cu­ment Con­trol” mo­du­le. In the pro­cess, the do­cu­ment cir­cu­la­ti­on is set through con­fi­gu­ra­ti­on. Dif­fe­rent (sin­gle or mul­ti­le­vel) do­cu­ment cir­cu­la­ti­ons can be stored for each do­cu­ment tem­pla­te. Thus, it can be cus­to­mi­zed to your needs and pro­ce­du­res. The sys­tem au­to­ma­ti­cal­ly as­signs cor­re­spon­ding “Pe­rio­dic Re­view” tasks to the ap­pro­pria­te em­ployees. The in­te­gra­ted re­min­der and es­ca­la­ti­on ma­nage­ment sys­tem no­ti­fies when dead­lines are ex­cee­ded and tasks are past their due date. 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 can 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. 

Dispatch at the touch of a button 

Di­gi­tal­ly hand­le the do­cu­ment dis­tri­bu­ti­on and the si­gna­tu­re cir­cu­la­ti­on at the touch 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 of 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 pre­ser­ves the en­vi­ron­ment and your ner­ves as well as saves you money. 

Central information platform 

Use the d.3ecm sys­tem as your cen­tral in­for­ma­ti­on plat­form on which you can re­trie­ve all your data on 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 re­leased templates
  • The tem­pla­tes may also be con­trol­led documents
  • Ma­nage­ment of spe­ci­fi­ca­ti­on do­cu­ments 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 com­pul­so­ry watermark
  • Easy crea­ti­on of re­port lists
  • Con­trol­led and log­ged printing
  • Com­pa­ri­son of do­cu­ment ver­si­ons and vi­sua­liz­a­ti­on of differences
  • In­te­gra­ted ar­chi­ving on the ba­sis of the d.3ecm system
  • Win­dows and web frontend
  • Pe­rio­dic review

Which regulations must be observed for controlled documents?
  • ISO 9001:2015, Chap­ter 7.5
  • ISO 13485:2016, Chap­ter 4
  • FDA 21 CFR Part 11
  • EU GMP Gui­de, An­nex 11
  • WHO gui­de­li­nes on good prac­ti­ces in data and re­cord management
  • EFG-Vo­tum V11002: Re­qui­re­ments re­gar­ding the elec­tro­nic data storage
  • EFG-Vo­tum V11003: Re­qui­re­ments re­gar­ding elec­tro­nic si­gna­tures and initials

Get to know our software better
Illustration of a notebook on which the document control of d.velop Life Sciences is displayed
Do­cu­ments

All do­cu­ments and their pro­per­ties that match your se­arch cri­te­ria wi­t­hin the DMS se­arch are dis­play­ed here.

The d.3 life sci­ence cli­ent icon in the up­per left cor­ner opens the menu. If you choo­se a menu or sub­me­nu item, the cor­re­spon­ding re­sults list is dis­play­ed in the Over­view window.

Drop Zone

Con­trol­led and non-con­trol­led do­cu­ments as well as any do­cu­ment ty­pes and file for­mats can be stored by drag & drop via the Drop Zone.

Rea­ding Pane

For each do­cu­ment, a pre­view can be dis­play­ed in the fle­xi­b­ly cus­to­miz­ab­le rea­ding pane. 

Rib­bon

The ap­p­li­ca­ti­on win­dow of the d.3 life sci­ence cli­ent dis­plays the fol­lowing menu items de­pen­ding on the user, li­cen­sed mo­du­le and authorization:

  • DMS
  • My QM
  • Pro­cess Participation
  • Ad­mi­nis­tra­ti­on
  • EQM
  • Con­tract Management
  • HRM
Do­cu­ment status

The do­cu­ment sta­tus dif­fe­ren­tia­tes between:

  • Pro­ces­sing (red)
  • In cir­cu­la­ti­on (yel­low)
  • Re­leased (green)
  • Wi­th­drawn (blue)
  • Trai­ning pha­se (pur­p­le)
DMS Se­arch

Do­cu­ments can be found using va­rious se­arch cri­te­ria and at­tri­bu­tes. The se­arch re­sult is dis­play­ed in a re­sults list on the right side in a tab. Of cour­se, a full-text se­arch as well as a se­arch via vi­su­al ele­ments is also possible. 

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.

To the Live-WebCast

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 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 re­pro­du­ce dif­fe­rent hier­ar­chi­cal le­vels of the QM do­cu­men­ta­ti­on. The QM ma­nu­al in­clu­des uni­ver­sal­ly va­lid do­cu­ments such as po­li­ci­es, for ex­amp­le, and re­fers to the other two un­der­ly­ing hier­ar­chy ty­pes for a de­tail­ed de­fi­ni­ti­on of ope­ra­ting instructions.
Do­cu­ment cir­cu­la­ti­ons (e.g. re­view, ap­pro­val, re­lease, trai­ning, ent­ry into for­ce) can be fle­xi­b­ly con­fi­gu­red and ad­ap­ted to your com­pa­ny re­qui­re­ments. The cir­cu­la­ti­on is lin­ked to the do­cu­ment tem­pla­te, so a dif­fe­rent cir­cu­la­ti­on could be de­fi­ned for each template.
You can de­ter­mi­ne whe­ther and which em­ployees and/or em­ployee pro­files can be selec­ted in each in­di­vi­du­al step. You can also de­ter­mi­ne whe­ther a mi­ni­mum or ma­xi­mum num­ber of peop­le are in­vol­ved in a step and spe­ci­fy a par­ti­cu­lar person/profile or make it mandatory.
The ent­ry into for­ce is al­ways the last step in a do­cu­ment cir­cu­la­ti­on and usual­ly ta­kes place au­to­ma­ti­cal­ly at the end of the sche­du­led trai­ning pha­se. It is howe­ver also pos­si­ble to put the do­cu­ments into for­ce manually.
In a do­cu­ment cir­cu­la­ti­on you can de­ci­de if you want to have a pe­rio­dic re­view task sent. If a pe­rio­dic re­view is plan­ned, the re­lea­ser re­cei­ves a date pro­po­sal ba­sed on the con­fi­gu­ra­ti­on (e.g. 2 ye­ars af­ter the ent­ry into for­ce) and a pe­rio­dic re­view task is sent ap­pro­pria­te­ly in advance.

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

In­de­pendent­ly of the ad­di­tio­nal func­tions in the ‘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. In the first dis­tri­bu­ti­on list you select tho­se users who will re­cei­ve the task for the read-and-un­ders­tood trai­ning af­ter the do­cu­ment is re­leased. 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.
By me­ans of a num­be­ring sche­me a uni­que num­ber can be as­si­gned to each 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 pro­per­ties and in the pre­view and can also be ac­ces­sed di­rect­ly here. You can con­fi­gu­re that the aut­hor of a do­cu­ment re­cei­ves a no­ti­fi­ca­ti­on when a fur­ther ap­p­li­ca­ble 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 au­dit trail in­for­ma­ti­on, elec­tro­nic si­gna­tures etc.). A prin­ting re­a­son must be spe­ci­fied 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 ‘Con­fir­ma­ti­on of Prin­tout Return’.
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 re­pla­ces 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 the review/approval/release has been re­jec­ted in the do­cu­ment cir­cu­la­ti­on. The aut­hor crea­tes a new edi­t­ing ver­si­on and re­starts the cir­cu­la­ti­on. All ver­si­ons of a con­trol­led do­cu­ment can be view­ed by aut­ho­ri­zed users. A di­rect do­cu­ment com­pa­ri­son of two ver­si­ons is also avail­ab­le here.

Customer review on the Document Control

to the re­fe­rence overview

“Ye­ars ago, we used to track the sta­tus of do­cu­ments such as work in­st­ruc­tions, em­ployee qua­li­fi­ca­ti­on re­cords and batch re­ports using an Ac­cess da­ta­ba­se or on pa­per. Howe­ver, it was te­dious to keep the do­cu­ments up to date and to ma­na­ge them in an au­dit-com­pli­ant man­ner. In 2012, we swit­ched to the di­gi­tal do­cu­ment con­trol of d.velop Life Sci­en­ces, which was a quan­tum leap. To­day we can crea­te, find, edit and agree upon do­cu­ments much fas­ter. This saves working time and costs.”

Björn Box­ham­merHead of Qua­li­ty As­suran­ce & IT (Ho­möo­pa­thi­sches La­bo­ra­to­ri­um Alex­an­der Pflü­ger GmbH & Co. KG)
Björn Boxhammer

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