Controlled Documents — GxP-compliant digitization solutions from d.velop Life Sciences GmbH

d.velop Life Sci­en­ces GmbH is your part­ner for GxP-com­pli­ant do­cu­men­ta­ti­on so­lu­ti­ons in the phar­maceu­ti­cal in­dus­try, me­di­cal tech­no­lo­gy, dia­gnostics, he­alth­ca­re sec­tor, food in­dus­try, con­tract ma­nu­fac­tu­ring and steel industry.

Be it Do­cu­ment Con­trol , De­via­ti­on Ma­nage­ment (DC)CAPAPro­cess Do­cu­men­ta­ti­onDi­gi­tal Per­son­nel FileTrai­ning Ma­nage­mentChan­ge Ma­nage­ment (CC) or Con­tract Ma­nage­ment – our so­lu­ti­ons are to be un­ders­tood as a com­ple­men­ta­ry sup­ple­ment to d.3 and pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses of ma­nu­fac­tu­ring / pro­duc­tion and qua­li­ty management.

Find out more about GxP-com­pli­ant di­gi­tiz­a­ti­on op­ti­ons for your do­cu­ments here.

The fo­cus of our di­gi­tiz­a­ti­on so­lu­ti­ons  is on the con­trol of re­cords and ar­chi­ving, the con­trol of do­cu­ments, as well as on QM pro­ces­ses ac­com­pany­ing pro­duc­tion. Whe­ther con­trol­led do­cu­ments, di­gi­tal plan­ning and do­cu­men­ta­ti­on of the qua­li­fi­ca­ti­on le­vel of your em­ployees, di­gi­tiz­a­ti­on of your ISO pro­ces­ses, di­gi­tal con­tract ma­nage­ment, the pro­cess do­cu­men­ta­ti­on mo­du­le or elec­tro­nic ma­nage­ment and ar­chi­ving of your ma­nu­fac­tu­ring do­cu­men­ta­ti­on — our pro­ducts have al­rea­dy been in­tro­du­ced and suc­cess­ful­ly va­li­da­ted in nu­me­rous companies.

Mo­reo­ver, our pro­ducts have been suc­cess­ful­ly­au­di­ted in TÜV au­dits ac­cord­ing to the gui­de­li­nes of ISO stan­dards 9001 and 13485 and in in­spec­tions by the re­gio­nal coun­cil (Ger­ma­ny). We are plea­sed to have a cus­to­mer base of over 70 cus­to­mers. The ma­jo­ri­ty of our cus­to­mers are pro­jects from the life sci­en­ces sec­tor that re­qui­re va­li­da­ti­on.

Controlled Documents — electronic document management minimizes process times

Every day, we deal with a lar­ge num­ber of dif­fe­rent do­cu­ments, while fur­ther­mo­re, a mass of in­for­ma­ti­on is ge­ne­ra­ted that needs to be pro­ces­sed quick­ly and re­li­ab­ly. In the pro­cess, count­less do­cu­ments are crea­ted, ve­ri­fied, edi­ted, dis­tri­bu­t­ed, stored or de­s­troy­ed. It’s good if the­re are ru­les for do­cu­ment con­trol and you can ma­na­ge ever­ything in your com­pa­ny di­gi­tal­ly.

With our di­gi­tiz­a­ti­on so­lu­ti­ons you can ma­na­ge your spe­ci­fi­ca­ti­on do­cu­ments such as work and pro­cess in­st­ruc­tions, test spe­ci­fi­ca­ti­ons, hy­gie­ne plans and ope­ra­ting in­st­ruc­tions as well as forms, con­tracts and other do­cu­ment ty­pes ful­ly elec­tro­ni­cal­ly. This al­lows you to si­gni­fi­cant­ly re­du­ce pro­cess run­ti­mes for the crea­ti­on, re­vi­si­on, re­lease and dis­tri­bu­ti­on of your stan­dard do­cu­ments — the si­gna­tu­re cir­cu­la­ti­on and dis­tri­bu­ti­on of do­cu­ments is done at the push of a but­ton. In ad­di­ti­on, red­un­dant prin­touts can be re­du­ced and at the same time the en­vi­ron­ment and ner­ves are spa­red.

Op­ti­mi­ze the ma­nage­ment of spe­ci­fi­ca­ti­on do­cu­ments and forms — re­gu­la­ted / con­trol­led do­cu­ments are crea­ted wi­t­hin the sys­tem ba­sed on ap­pro­ved tem­pla­tes. The tem­pla­tes may also be con­trol­led do­cu­ments, themselves.

You can now sign do­cu­ments elec­tro­ni­cal­ly — our in­te­gra­ted GxP-com­pli­ant si­gna­tu­re so­lu­ti­on is pu­re­ly soft­ware-ba­sed. Our di­gi­tal so­lu­ti­ons for do­cu­ment con­trol also en­ab­le pe­rio­dic re­views and the con­ve­ni­ent crea­ti­on of re­port lists. All do­cu­ments re­cei­ve an in­di­vi­du­al and dy­na­mic for­ced wa­ter­mark — also a con­trol­led and log­ged prin­tout is avail­ab­le. Our di­gi­tiz­a­ti­on so­lu­ti­ons en­ab­le full text se­ar­ches ba­sed on do­cu­ment con­tent and do­cu­ment at­tri­bu­tes (me­ta­da­ta) as well as in­te­gra­ted ar­chi­ving ba­sed on the d.3ecm system.

Solutions for document control

Our d.3 so­lu­ti­ons can­not only be used for QM pro­ces­ses — we of­fer you in­no­va­ti­ve so­lu­ti­ons for do­cu­ment con­trol which can be ad­ap­ted to the life cy­cle of your spe­ci­fi­ca­ti­on do­cu­ments and forms.

From crea­ti­on to your can­cel­la­ti­on, all do­cu­ments are pas­sed elec­tro­ni­cal­ly through the soft­ware. Ap­pro­val work­flows with elec­tro­nic si­gna­tures as well as the pu­bli­ca­ti­on and dis­tri­bu­ti­on of do­cu­ments can be in­te­gra­ted. The con­sis­tent in­te­gra­ti­on of our trai­ning mo­du­le com­ple­tes your di­gi­tiz­a­ti­on strategy.

Our do­cu­ment con­trol sys­tem meets the fol­lowing re­gu­la­to­ry requirements:

  • ISO 9001:2015, Chap­ter 7.5
  • ISO 13485:2016, Chap­ter 4
  • FDA 21 CFR Part 11
  • EU-GMP gui­de­li­ne, An­nex 11
  • WHO: “Gui­d­ance Do­cu­ment on Good Data and Re­cord Ma­nage­ment Practices”
  • EFG-Vo­tum V11002: Re­qui­re­ments re­gar­ding the elec­tro­nic data storage
  • EFG-Vo­tum V11003: Re­qui­re­ments re­gar­ding elec­tro­nic si­gna­tures and initials

Do you have ques­ti­ons about con­trol­led do­cu­ments and our di­gi­tiz­a­ti­on so­lu­ti­ons? Then con­ta­ct us — our ex­pe­ri­en­ced col­leagues will be hap­py to ad­vi­se you in de­tail about the re­spec­ti­ve spe­cia­list area.

Comprehensive service

Ar­chi­ve your do­cu­ments with d.3 life sci­en­ces, our so­lu­ti­on suite which is built on the pro­ven d.3 ecm of d.velop AG. Re­gard­less if of­fers, in­voices, de­li­very no­tes, batch pro­ces­sing re­cords or test re­cords — all are stored in the cen­tral di­gi­tal ar­chi­ve, of cour­se in com­pli­an­ce with the re­gu­la­to­ry re­qui­re­ments like GoBD or GxP .

Our so­lu­ti­ons are spe­cia­li­zed on the life cy­cle of its spe­ci­fi­ca­ti­ons and form she­ets. If pa­per prin­touts are still re­qui­red, we check the­se with our con­trol­led prin­ting. Wi­t­hin the frame­work of do­cu­ment con­trol, all do­cu­ments are ma­na­ged elec­tro­ni­cal­ly from their crea­ti­on to their in­va­li­da­ti­on. Ap­pro­val work­flows with elec­tro­nic si­gna­tu­re are in­te­gra­ted just like the pu­bli­ca­ti­on and dis­tri­bu­ti­on of do­cu­ments. The sys­tem also ta­kes care of the trai­ning ma­nage­ment in terms of plan­ning and do­cu­men­ting the ade­qua­te trai­ning of your em­ployees for their re­spec­ti­ve task pane.

Pro­ces­ses such as De­via­ti­on Con­trolCor­rec­ti­ve and Pre­ven­ti­ve Ac­tions (CAPA) and Chan­ge Con­trol can be ea­si­ly con­trol­led with our elec­tro­nic workflows.

With us you can al­ways rely on pro­fes­sio­nal com­pe­tence and ex­cel­lent cus­to­mer ser­vice. We would be plea­sed to ad­vi­se you in de­tail about our d.3 so­lu­ti­on for qua­li­ty ma­nage­ment as well as our com­pre­hen­si­ve ser­vice portfolio.

Use d.3 for your  qua­li­ty ma­nage­ment and do­cu­ment-ba­sed pro­ces­ses as well — of cour­se, we are at your dis­po­sal for a de­tail­ed consultation.

Sim­ply con­ta­ct us — we will help you with ques­ti­ons and con­cerns in a com­pe­tent and friend­ly manner.

Con­vin­ce yourself of the nu­me­rous ad­van­ta­ges of our di­gi­ta­liz­a­ti­on so­lu­ti­ons !

Are you looking for a solution to control your documents?

Then take a look at our so­lu­ti­on now