GxP-compliant software for your document & quality management

Your path to digitalization

GxP-compliant software for your document & quality management

Control of recordings
and archiving

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Ar­chi­ve your do­cu­ments with d.3 life sci­en­ces, our so­lu­ti­on suite, which is ba­sed on the pro­ven d.3ecm by 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.

Espe­cial­ly for GxP re­qui­re­ments we have ex­pan­ded our ar­chi­ve sys­tem by elec­tro­nic si­gna­tu­re so­lu­ti­ons ac­cord­ing to FDA CFR Part 11 and EU GMP gui­de­li­nes an­nex 11. Thus, you can e.g. re­lease your batch do­cu­men­ta­ti­on and keep your batch re­cord electronically.

Document control 

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Our so­lu­ti­ons are spe­cia­li­zed in the life cy­cle of your spe­ci­fi­ca­ti­on do­cu­ments and forms. If you still re­qui­re pa­per prin­touts, we also con­trol the­se with the help of our con­trol­led print.

All do­cu­ments are ma­na­ged elec­tro­ni­cal­ly from crea­ti­on un­til their im­ple­men­ta­ti­on. 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 area.

accompanying production
QM processes

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Con­trol pro­ces­ses such as Com­p­laints, De­via­ti­on Con­trol, Cor­rec­ti­ve And Pre­ven­ti­ve Ac­tions (CAPA) and Chan­ge Con­trol with our di­gi­tal workflows. 

Our so­lu­ti­ons sup­port you in the crea­ti­on of re­ports like e.g. PQR. Ea­si­ly crea­te sta­tis­tics on fre­quen­cy, cri­ti­ca­li­ty or lead time of your QM processes.

Pro­vi­ded they are aut­ho­ri­zed, also em­ployees who are not in­vol­ved in the pro­cess, have an over­view of the cur­rent pro­ces­ses. Thus, you in­cre­a­se trans­pa­ren­cy and the in­for­ma­ti­ve va­lue in your company.

Control of recordings and archiving

Ar­chi­ve your do­cu­ments with d.3 life sci­en­ces, our so­lu­ti­on suite, which is ba­sed on the pro­ven d.3ecm by 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.

Espe­cial­ly for GxP re­qui­re­ments we have ex­pan­ded our ar­chi­ve sys­tem by elec­tro­nic si­gna­tu­re so­lu­ti­ons ac­cord­ing to FDA CFR Part 11 and EU GMP gui­de­li­nes an­nex 11. Thus, you can e.g. re­lease your batch do­cu­men­ta­ti­on and keep your batch re­cord electronically.

Document control

Our so­lu­ti­ons are spe­cia­li­zed in the life cy­cle of your spe­ci­fi­ca­ti­on do­cu­ments and forms. If you still re­qui­re pa­per prin­touts, we also con­trol the­se with the help of our con­trol­led print.

All do­cu­ments are ma­na­ged elec­tro­ni­cal­ly from crea­ti­on un­til their im­ple­men­ta­ti­on. 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 area.

QM processes accompanying production

Con­trol pro­ces­ses such as Com­p­laints, De­via­ti­on Con­trol, Cor­rec­ti­ve And Pre­ven­ti­ve Ac­tions (CAPA) and Chan­ge Con­trol with our di­gi­tal workflows.

Our so­lu­ti­ons sup­port you in the crea­ti­on of re­ports like e.g. PQR. Ea­si­ly crea­te sta­tis­tics on fre­quen­cy, cri­ti­ca­li­ty or lead time of your QM processes.

Pro­vi­ded they are aut­ho­ri­zed, also em­ployees who are not in­vol­ved in the pro­cess, have an over­view of the cur­rent pro­ces­ses. Thus, you in­cre­a­se trans­pa­ren­cy and the in­for­ma­ti­ve va­lue in your company.

We sol­ve real problems

Your path to digitalization

Emblem for the software solution Document Control

Document Control

Whe­ther work / pro­cess in­st­ruc­tions (SOPs), pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons or other ty­pes of do­cu­ments — you can crea­te, re­vi­se and sign them all di­gi­tal­ly with this module.

Emblem for the software solution Training Management

Training Management

Ex­tend the “Do­cu­ment Con­trol” mo­du­le to ac­tively plan and re­cord the qua­li­fi­ca­ti­ons of your em­ployees with our trai­ning management.

Emblem for the software solution E-Learning

E‑Learning

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

Emblem for the software solution Document Control

Document Control

Whe­ther work / pro­cess in­st­ruc­tions (SOPs), pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons or other ty­pes of do­cu­ments — you can crea­te, re­vi­se and sign them all di­gi­tal­ly with this module.

Emblem for the software solution Training Management

Training Management

Ex­tend the “Do­cu­ment Con­trol” mo­du­le to ac­tively plan and re­cord the qua­li­fi­ca­ti­ons of your em­ployees with our trai­ning management.

Emblem for the software solution E-Learning

E‑Learning

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

Emblem for the software solution QM Workflows

QM Workflows (Complaint | DC | CAPA | CC)

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

Emblem for the software solution QM Workflows

QM Workflows (Complaint | DC | CAPA | CC)

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

Emblem for the software solution Technical Documentation

Technical Documentation

Crea­te and up­date your tech­ni­cal do­cu­men­ta­ti­on, e.g. in ac­cordance with the re­qui­re­ments of the Me­di­cal De­vice Re­gu­la­ti­on (MDR).

Emblem for the software solution Contract Management

Contract Management

Keep track of your con­tracts. Let us re­mind you about key dates such as ter­mi­na­ti­on op­ti­ons or re­ne­wal op­ti­ons in a mul­ti-sta­ge procedure.

Emblem for the software solution Technical Documentation

Technical Documentation

Crea­te and up­date your tech­ni­cal do­cu­men­ta­ti­on, e.g. in ac­cordance with the re­qui­re­ments of the Me­di­cal De­vice Re­gu­la­ti­on (MDR).

Emblem for the software solution Contract Management

Contract Management

Keep track of your con­tracts. Let us re­mind you about key dates such as ter­mi­na­ti­on op­ti­ons or re­ne­wal op­ti­ons in a mul­ti-sta­ge procedure.

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Customers trust d.velop life sciences

The qua­li­ty of our work has many na­mes. In the fol­lowing you will find a small ex­cerpt from our cus­to­mer list of about 120 com­pa­nies from va­rious in­dus­tries. We would like to thank our cus­to­mers for their con­fi­dence in us and our solutions.

Cus­to­mer reviews

What do our customers say about us?

2000
Year of foundation
~ 80
Life Sci­en­ces Customers
40000
ever­y­day users

Do you want to take your business to the next level?

Lea­ve a mes­sa­ge. We will get back to you!

In the meeting room, the female executive shows the male investor a digital tablet computer.