DOCUMENT CONTROL SOFTWARE

Efficient software for your document control

Di­gi­tal do­cu­ment con­trol en­su­res com­pli­ance with re­gu­la­to­ry re­qui­re­ments and im­pro­ves the trans­pa­ren­cy and tracea­bi­li­ty of your do­cu­men­ta­ti­on-ba­sed processes.

Ma­na­ge con­trol­led do­cu­ments ef­fi­ci­ent­ly and securely 

Com­pli­ance with your re­gu­la­to­ry requirements 

Make busi­ness pro­ces­ses fu­ture-pro­of and digital 

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» dls | do­cu­ment control «

Control your documents with the module “document control”

Our soft­ware so­lu­ti­on “dls | do­cu­ment con­trol” en­ables you to crea­te, re­vi­se, and sign a wide ran­ge of do­cu­ment ty­pes com­ple­te­ly di­gi­tal­ly, in­clu­ding SOPs, work and pro­cess in­s­truc­tions, test spe­ci­fi­ca­ti­ons, ope­ra­ting in­s­truc­tions, gui­de­lines, ma­nu­fac­tu­ring do­cu­ments, con­tracts, and more. The do­cu­ment cir­cu­la­ti­on is con­fi­gu­red fle­xi­bly so that dif­fe­rent do­cu­ment cir­cu­la­ti­ons (sin­gle or mul­ti-le­vel) can be de­fi­ned de­pen­ding on the do­cu­ment tem­p­la­te. The sys­tem au­to­ma­ti­cal­ly as­signs “Pe­ri­odic re­view” tasks to the re­spec­ti­ve em­ployees. Missed dead­lines and pen­ding tasks are in­di­ca­ted by an in­te­gra­ted re­min­der and es­cala­ti­on ma­nage­ment sys­tem. Par­ti­ci­pa­ti­on in the au­to­ma­ted ap­pr­oval pro­cess is con­firm­ed by an elec­tro­nic and GxP-com­pli­ant si­gna­tu­re. Mo­reo­ver, in­te­gra­ted au­dit trails in­crease the tracea­bi­li­ty and trans­pa­ren­cy of each document.

How can you benefit from the Document Control software?

Digital Document 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 

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 un­aut­ho­ri­sed users and from de­s­truc­ti­ve forces. 

Individual configuration 

Let the mo­du­les be con­fi­gu­red ac­cor­ding to your needs and pre­fe­ren­ces to sim­pli­fy the on­boar­ding trai­ning of your colleagues. 

Minimization of process runtimes 

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

Reduction of resources 

Re­du­ce un­neces­sa­ry prin­ting and pa­per on your desk to pro­tect the en­vi­ron­ment, avo­id stress, and save money. 

Central information platform 

Use d.velop do­cu­ments (form­er­ly d.3ecm) as your cen­tral in­for­ma­ti­on plat­form to ac­cess your data at any time. 

Constant availability 

Ac­cess your data at any time and from anywhere. 

Optimize processes with document control

Get to know our document control software better

Illustration of a notebook on which the document control of Digital Life Sciences is mapped
Do­cu­ments

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

The menu is ope­ned via the dls | eQMS icon in the top left-hand cor­ner. If you choo­se a menu or sub­me­nu item, the cor­re­spon­ding re­sult 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 cus­to­mi­sable re­a­ding pane.

Rib­bon

De­pen­ding on the user, li­cen­sed mo­du­le, and aut­ho­ri­sa­ti­on, the fol­lo­wing menu items are available in the dls | eQMS ap­pli­ca­ti­on window:

Do­cu­ment status

The do­cu­ment sta­tus dif­fe­ren­tia­tes between:

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

Do­cu­ments can be found using va­rious search cri­te­ria and at­tri­bu­tes. The search re­sult is dis­play­ed in a re­sult 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 insight into document control software?

Get a per­so­nal live in­sight into the many pos­si­bi­li­ties of do­cu­ment con­trol in just 45 mi­nu­tes using an il­lus­tra­ti­ve use case. Find out how you can use Di­gi­tal Life Sci­en­ces so­lu­ti­ons to elec­tro­ni­cal­ly crea­te, re­vi­se, and di­gi­tal­ly sign your work and pro­cess in­s­truc­tions (SOPs), pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons, ope­ra­ting in­s­truc­tions, con­tracts, or any other type of document.

Some features of the Document Control

Which regulations must be observed for controlled documents?

ISO 9001:2015, Chap­ter 7.5

ISO 13485:2016, Chap­ter 4 

EU GMP Gui­de, An­nex 11 

WHO Gui­de­lines on Good Prac­ti­ces in Data and Re­cord Management 

EFG-Vo­tum V11002: Re­qui­re­ments re­gar­ding elec­tro­nic data storage 

EFG-Vo­tum V11003: Re­qui­re­ments re­gar­ding elec­tro­nic si­gna­tures and initials 

33 Good reasons to work with Digital LS

You are not con­vin­ced yet? Find out about 33 good re­asons spea­king for a co­ope­ra­ti­on with Di­gi­tal 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.

Customer review on the Document Control

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Do­cu­ment con­trol is a com­po­nent of the Di­gi­tal Life Sci­en­ces so­lu­ti­on suite. Each pro­duct is powerful on its own, but when used tog­e­ther they are even better.

Emblem for the software solution training management

Training Management software

Ex­tend the mo­du­le “Do­cu­ment Con­trol” to ac­tively plan and log your em­ployees’ qua­li­fi­ca­ti­ons with our trai­ning ma­nage­ment software.

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E‑learning software

Use the new “E‑learning” soft­ware to train your em­ployees di­gi­tal­ly. Crea­te e‑learnings ac­cor­ding to your wis­hes using Mi­cro­soft Power­Point or in­te­gra­te exis­ting presentations.

Emblem for the software solution QM processes

QM processes (Complaint | DC | CAPA | CC)

Di­gi­ta­li­se your ISO pro­ces­ses. Con­trol your pro­duc­tion-re­la­ted QM pro­ces­ses using di­gi­tal workflows.

Frequently asked questions (FAQs) about Document Control

For the ma­nage­ment of QM do­cu­ments, the dls | eQMS can ma­na­ge the th­ree do­cu­ment ca­te­go­ries ‘QM ma­nu­al’, ‘Pro­cess in­s­truc­tions’ and ‘Work in­s­truc­tions’. 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, set­ting ef­fec­ti­ve) can be fle­xi­bly con­fi­gu­red and ad­apt­ed to your com­pa­ny re­qui­re­ments. The do­cu­ment cir­cu­la­ti­on is lin­ked to the do­cu­ment tem­p­la­te; thus, a dif­fe­rent do­cu­ment 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.

Set­ting a do­cu­ment ef­fec­ti­ve is al­ways the last step in a do­cu­ment cir­cu­la­ti­on and usual­ly ta­kes place au­to­ma­ti­cal­ly at the end of the sche­du­led trai­ning pe­ri­od. Ho­we­ver, it is also pos­si­ble to set do­cu­ments ma­nu­al­ly effective.

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 do­cu­ment has been set ef­fec­ti­ve) and a pe­ri­odic re­view task is sent ap­pro­pria­te­ly in advance.

The task for the pe­ri­odic re­view can be sent to dif­fe­rent per­sons or ac­ti­vi­ty pro­files (e.g. re­view­ers, ap­pro­vers, releasers).

In­de­pendent­ly of the ad­di­tio­nal fea­tures in the ‘trai­ning ma­nage­ment’, you can store a do­cu­ment dis­tri­bu­ti­on list on the ba­sis of which the ‘Bin­ding for list’ for a do­cu­ment is crea­ted. If do­cu­ment dis­tri­bu­ti­on is used, a first dis­tri­bu­ti­on list is spe­ci­fied in the do­cu­ment cir­cu­la­ti­on. In the first dis­tri­bu­ti­on list, tho­se em­ployees are sel­ec­ted 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.

Do­cu­ment con­trol im­pro­ves the life­cy­cle of do­cu­ments and re­cords by en­su­ring that all do­cu­ments and in­for­ma­ti­on are con­trol­led sys­te­ma­ti­cal­ly and ef­fi­ci­ent­ly. A DMS sup­ports the­se pro­ces­ses by or­ga­ni­s­ing the en­ti­re life­cy­cle from the crea­ti­on and ar­chi­ving to the dis­po­sal of do­cu­ments and re­cords. This leads to im­pro­ved do­cu­men­ta­ti­on and seam­less in­te­gra­ti­on into the company’s qua­li­ty management.

Do­cu­ment con­trol is es­sen­ti­al for the ma­nage­ment of in­for­ma­ti­on and ch­an­ges, as it en­su­res that all do­cu­ments and in­for­ma­ti­on are cor­rect­ly do­cu­men­ted and mo­ni­to­red. With a DMS, ch­an­ges and im­portant re­cords can be tra­cked seam­less­ly, which in­crea­ses the qua­li­ty of the in­for­ma­ti­on. This is cru­cial for re­lia­ble qua­li­ty ma­nage­ment and helps the com­pa­ny to en­su­re a high le­vel of ac­cu­ra­cy and con­sis­ten­cy in its processes.

Do­cu­ment con­trol con­tri­bu­tes to the ef­fec­ti­ve ar­chi­ving and ma­nage­ment of do­cu­ments and re­cords by im­ple­men­ting pro­ces­ses that en­su­re the cor­rect hand­ling and sto­rage of all do­cu­ments. A DMS en­ables com­pa­nies to ma­na­ge do­cu­ments and in­for­ma­ti­on cen­tral­ly, which sim­pli­fies ar­chi­ving and ma­nage­ment. This sup­ports do­cu­men­ta­ti­on and en­su­res that all do­cu­ments are cor­rect­ly con­trol­led and available th­roug­hout their en­ti­re lifecycle.

A do­cu­ment is as­si­gned to an aut­hor to whom editing is re­ser­ved. Ho­we­ver, aut­hor­ship can be trans­fer­red to an­o­ther em­ployee so that they can add fur­ther con­tent if necessary.

By me­ans of a num­be­ring sche­me, a uni­que num­ber can be as­si­gned to each do­cu­ment in the dls | eQMS. Hier­ar­chi­cal num­be­ring is also available here, which has an im­pact on the re­lease pro­ces­ses. For ex­am­p­le, an at­tach­ment crea­ted with a hier­ar­chi­cal num­be­ring sys­tem can only be re­leased if the hig­her-le­vel do­cu­ment has been 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 aut­ho­ri­sa­ti­on, an em­ployee can print con­trol­led do­cu­ments. Du­ring con­trol­led prin­ting, the em­ployee 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 fea­ture 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. Se­ve­ral pro­ces­sing ver­si­ons can exist if the review/approval/release was re­jec­ted in the do­cu­ment cir­cu­la­ti­on. The aut­hor crea­tes a new pro­ces­sing ver­si­on and re­starts the cir­cu­la­ti­on. All ver­si­ons of a con­trol­led do­cu­ment can be view­ed by aut­ho­ri­sed users. A di­rect do­cu­ment com­pa­ri­son of two ver­si­ons is also available here.

A DMS of­fers num­e­rous ad­van­ta­ges in the con­text of do­cu­ment con­trol by im­pro­ving pro­cess op­ti­mi­sa­ti­on and the ma­nage­ment of do­cu­ments and in­for­ma­ti­on. Elec­tro­nic ar­chi­ving and the cen­tral ma­nage­ment of re­cords enable com­pa­nies to make their do­cu­men­ta­ti­on more ef­fi­ci­ent and trans­pa­rent. A DMS sup­ports tracea­bi­li­ty and qua­li­ty ma­nage­ment by or­ga­ni­s­ing and ma­king ac­ces­si­ble all ch­an­ges and im­portant information.

Ef­fi­ci­ent do­cu­ment con­trol can si­gni­fi­cant­ly im­pro­ve know­ledge and in­for­ma­ti­on wi­thin the com­pa­ny by en­su­ring that all re­le­vant do­cu­ments and in­for­ma­ti­on are cor­rect­ly con­trol­led and do­cu­men­ted. A DMS fa­ci­li­ta­tes ac­cess to im­portant re­cords and in­for­ma­ti­on and stores ch­an­ges in a traceable man­ner. This pro­mo­tes in­ter­nal know­ledge, op­ti­mi­ses pro­ces­ses and im­pro­ves qua­li­ty ma­nage­ment, as all em­ployees al­ways have ac­cess to up-to-date and ac­cu­ra­te information.

Do­cu­ment con­trol plays a key role in the risk ma­nage­ment pro­cess, as it en­su­res that all re­le­vant in­for­ma­ti­on is sys­te­ma­ti­cal­ly con­trol­led and cen­tral­ly ad­mi­nis­te­red. Thanks to a cle­ar­ly struc­tu­red pro­cess, all do­cu­men­ted risks are pre­cis­e­ly re­cor­ded and cru­cial in­for­ma­ti­on is made available at all times. This or­ga­nis­ed ma­nage­ment of in­for­ma­ti­on helps to iden­ti­fy po­ten­ti­al risks at an ear­ly stage and in­itia­te ap­pro­pria­te me­a­su­res, ther­eby op­ti­mi­sing over­all risk management.

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