From in­di­vi­du­al do­cu­ments to our do­cu­ment ma­nage­ment sys­tem and pro­cess-ori­en­ted dos­sier ma­nage­ment — our mo­du­le “d.velop life sci­en­ces | tech­ni­cal do­cu­ments” sup­ports and sim­pli­fies the crea­ti­on and up­dating of your tech­ni­cal do­cu­men­ta­ti­on, e.g. in the con­text of the re­qui­re­ments of the Me­di­cal De­vice Re­gu­la­ti­on (MDR). Our pro­cess-ori­en­ted dos­sier ma­nage­ment is ver­sa­ti­le, e.g. also for the crea­ti­on of site mas­ter files, tool log­books, drug mas­ter files, QM do­cu­men­ta­ti­on, pro­ject fol­ders, va­li­da­ti­on do­cu­men­ta­ti­on and much more.

How do you benefit from the Technical Documentation software?

Di­gi­tal management

Make ma­nu­al do­cu­men­ta­ti­on of dos­siers a thing of the past — in­s­tead, ma­na­ge them com­ple­te­ly digitally.

Struc­tu­red data maintenance

Let un­ti­dy file ser­vers with mul­ti­ple sto­rage lo­ca­ti­ons and red­un­dant fol­der struc­tures be a thing of the past.

In­cre­a­sed data security

Pro­tect your data from un­wan­ted ac­tions of un­aut­ho­ri­zed users as well as from de­st­ruc­ti­ve for­ces and stop worry­ing about im­mi­nent data loss.

In­di­vi­du­al configuration 

Let the mo­du­les be con­fi­gu­red ac­cord­ing to your wis­hes and pre­fe­ren­ces to fa­ci­li­ta­te the on­boar­ding trai­ning for your colleagues. 

Com­pli­an­ce with Me­di­cal De­vice Regulation 

Di­gi­tal­ly crea­te and up­date your tech­ni­cal do­cu­men­ta­ti­on wi­t­hin the re­qui­re­ments of the Me­di­cal De­vice Regulation.

Mi­ni­miz­a­ti­on of runtimes

Mi­ni­mi­ze pro­cess run­ti­mes for crea­ting, re­vi­sing and ap­pro­ving your dos­siers and re­du­ce un­ne­cessa­ry time spent on se­ar­ching and com­pi­ling the la­test documents.

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. 

Here are some features of the Technical Documentation

  • Ma­na­ge tem­pla­tes for dif­fe­rent struc­tures of your dossiers
  • Ma­na­ge tasks for the edi­tors of in­di­vi­du­al chap­ters of a dos­sier (work­flow)
  • Seam­less­ly in­te­gra­te into our Do­cu­ment Con­trol module
  • Check the com­ple­teness of your dossiers
  • Check the cur­rent edi­t­ing sta­tus of your dossier
  • Crea­te ver­si­ons of your dos­siers and ac­cess old ver­si­ons easily
  • Crea­te comments with dif­fe­rent priorities
  • Ex­port the en­t­i­re dos­sier or selec­ted parts as a PDF or ZIP file
  • Print the en­t­i­re dos­sier or selec­ted parts of it
  • Use the in­te­gra­ted elec­tro­nic and GxP-com­pli­ant si­gna­tu­re as well as au­dit trail functions
  • Clas­si­fi­ca­ti­on of dos­siers via at­tri­bu­tes in the d.3ecm system

Regulatory requirements for Technical Documentation

  • ISO 13485 MPG
  • Me­di­cal De­vice Re­gu­la­ti­on (MDR) — EU Di­rec­ti­ve MDR 2017/745

Would you like a live insight into the software?

Get a live in­sight into the pos­si­bi­li­ties of im­ple­men­ting a pro­cess-ori­en­ted dos­sier ma­nage­ment by me­ans of a sam­ple use case in only 45 mi­nu­tes. Learn how our so­lu­ti­on can sup­port and sim­pli­fy the crea­ti­on and up­dating of your tech­ni­cal do­cu­men­ta­ti­on wi­t­hin the re­qui­re­ments of the Me­di­cal De­vice Re­gu­la­ti­on (MDR).

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 Technical Documentation

Tem­pla­tes are avail­ab­le for fre­quent­ly used do­cu­men­ta­ti­on, e.g. ac­cord­ing to An­nex II of the MDR 2017/745. On the ba­sis of a struc­tu­re used by you, you can also amend tem­pla­tes yourself or have them crea­ted as part of the in­tro­duc­tion of the module.

You can cus­to­mi­ze chap­ter struc­tures and dos­sier tem­pla­tes or crea­te your own.

Using the tasks ‘Place­hol­ders’ and ‘Do­cu­ment crea­ti­on’ you spe­ci­fy which do­cu­ments the dos­sier must con­tain be­fo­re it can be released.

Do­cu­ments from your desk­top or from the file di­rec­to­ry can be used in the dos­sier. They are stored in the do­cu­ment ma­nage­ment sys­tem and used from the­re in one or more dossiers.

For each dos­sier, a main per­son re­spon­si­ble is iden­ti­fied, who also re­cei­ves the re­min­ders for com­ple­ti­on or pe­rio­dic re­view. In­di­vi­du­al chap­ters of the struc­tu­re can be trans­fer­red to a per­son par­ti­al­ly re­spon­si­ble for processing.

Do­cu­ments are ad­ded once to the con­tents list of the dos­sier and can then be in­ser­ted at several po­si­ti­ons in the struc­tu­re. Do­cu­ments can also be used in several dossiers.

When a dos­sier is re­leased, the ver­si­on is ‘fro­zen’, chan­ges are only pos­si­ble in a sub­se­quent ver­si­on. With the over­view ‘Ver­si­on sta­tu­ses’ you get an over­view of the do­cu­ment ver­si­ons. To ad­opt new ver­si­ons, crea­te a new ver­si­on of the dos­sier and de­ci­de which ver­si­on of the do­cu­ments to adopt.

For do­cu­ments ad­ded to the dos­sier as at­tach­ments, the va­lid re­lease ver­si­on is al­ways used.

Prin­ting of do­cu­ments is pos­si­ble, the func­tion de­pends on the spe­ci­fi­ca­ti­ons from the do­cu­ment ma­nage­ment sys­tem (con­trol­led — not controlled).

Ex­port as ZIP ar­chi­ve or PDF file is pos­si­ble for the who­le dos­sier or for selec­ted chap­ters / documents.

For the ZIP file, the pro­tec­tion is pre­set with a pass­word. Fur­ther­mo­re, you can pre­set the crea­ti­on of PDF/A files to pre­vent prin­ting and co­py­ing and en­ter a wa­ter­mark for each export.

The ac­tions are re­cor­ded in the au­dit trail of the dos­sier, in­clu­ding the out­put as a ZIP or PDF file and the ex­port of in­di­vi­du­al do­cu­ments. The au­dit trail stores the date and time of an ac­ti­vi­ty for the ac­tions lis­ted be­low. Mo­reo­ver, the ID of the user trig­ge­ring the ac­ti­vi­ty is stored in the au­dit trail entry.

Do­cu­ments can be in­ser­ted into the dos­sier re­gard­less of the file for­mat (PDF, MS Word, Ex­cel, Power­Point, PNG, JPG, TIFF, Visio)

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The Tech­ni­cal Do­cu­men­ta­ti­on is a com­po­nent of the d.velop life Sci­en­ces so­lu­ti­on suite. Each pro­duct is power­ful on its own, but when used tog­e­ther they are even better.

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 QM Workflows

QM Workflows (Complaint | DC | CAPA | CC)

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

Quick contact

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