Our software solution for your document & quality management 

Mo­du­lar. Ho­listic. Effective.

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Our di­gi­ta­liz­a­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty management.

The ba­sis of the d.3 life sci­en­ces sys­tem is a ho­listic ECM/DMS sys­tem. All soft­ware so­lu­ti­ons can be in­tro­du­ced as mo­du­lar buil­ding blocks and can be ex­pan­ded like a buil­ding block mo­del to a com­ple­te GxP-com­pli­ant eQMS suite. The buil­ding blocks high­ligh­ted in blue il­lus­tra­te this aspect.

The ECM/DMS sys­tem can also be ex­ten­ded to in­clu­de non-GxP ap­p­li­ca­ti­ons and can be lin­ked to your exis­ting ERP sys­tem (e.g. SAP), thus en­ab­ling you to im­ple­ment al­most all do­cu­ment-ba­sed pro­ces­ses in your company.

What is be­hind the solutions?

Get a compact short overview

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.

Frequently asked questions (FAQ’s) about the quality management system

As an an­s­wer, the Ger­man GMP re­gu­la­ti­ons, AMWHV, help us: The qua­li­ty ma­nage­ment sys­tem (QM sys­tem) is a sys­tem that in­clu­des qua­li­ty as­suran­ce, good ma­nu­fac­tu­ring prac­ti­ce or good work prac­ti­ce, in­clu­ding qua­li­ty con­trol and pe­rio­dic pro­duct qua­li­ty re­view (PQR) (§ 2 Definitions).

§3 Qua­li­ty ma­nage­ment sys­tem, good ma­nu­fac­tu­ring prac­ti­ce and good pro­fes­sio­nal practice

Com­pa­nies and fa­ci­li­ties must im­ple­ment a com­pa­ny qua­li­ty ma­nage­ment sys­tem (QM sys­tem) that cor­re­sponds to the type and scope of the ac­ti­vi­ties per­for­med. The QM sys­tem shall in­clu­de good ma­nu­fac­tu­ring prac­ti­ce in the ca­ses re­fer­red to in pa­ra­graph 2 and good pro­fes­sio­nal prac­ti­ce in the ca­ses re­fer­red to in pa­ra­graph 3, and shall pro­vi­de for the ac­ti­ve par­ti­ci­pa­ti­on of the ma­nage­ment of the es­tab­lish­ments and fa­ci­li­ties and of the per­son­nel of the va­rious sec­tors con­cer­ned. All are­as in­vol­ved in es­tab­li­shing, main­tai­ning and im­ple­men­ting the qua­li­ty ma­nage­ment sys­tem must have com­pe­tent per­son­nel and sui­ta­ble and suf­fi­ci­ent pre­mi­ses and equip­ment. The qua­li­ty ma­nage­ment sys­tem must be ful­ly do­cu­men­ted and its pro­per func­tio­n­ing de­mons­tra­ted (§ 1).

Cer­ti­fied com­pa­nies have long been the norm in ma­nu­fac­tu­ring and in­dus­tries with many pro­duc­tion steps. Howe­ver, it is also a fact that it’s in­cre­a­singly used in the ser­vice sec­tor. Ma­na­gers have un­ders­tood that pro­cess and “pro­duct” qua­li­ty are also me­thods in this area to dif­fe­ren­tia­te their own pro­duct from that of the com­pe­ti­ti­on. Fur­ther­mo­re, pro­cess qua­li­ty is an ef­fec­ti­ve way to avoid the cost of er­rors. That is why more and more com­pa­nies in the ser­vice sec­tor are re­ly­ing on the DIN EN ISO 9001 qua­li­ty ma­nage­ment stan­dard. The more spe­ci­fic the in­dus­try, the more spe­ci­fic the stan­dard. For ex­amp­le, la­bo­ra­to­ries have an ISO 17025 sys­tem, the au­to­mo­ti­ve in­dus­try has the IATF 16949 stan­dard, and me­di­cal de­vice ma­nu­fac­tu­rers have the ISO 13485 stan­dard. The­se ex­em­pla­ry stan­dards are all de­ri­ved from ISO 9001. Howe­ver, due to their re­spec­ti­ve fiel­ds, they of­ten have more ex­ten­si­ve re­qui­re­ments and more spe­ci­fic bases.

A qua­li­ty ma­nage­ment sys­tem (QMS) has many ad­van­ta­ges. It can lead to cost sa­vings and fa­ci­li­ta­te mar­ket ac­cess. A qua­li­ty ma­nage­ment sys­tem hel­ps com­pa­nies in the fol­lowing es­sen­ti­al aspects:

  • Im­pro­ved mar­ket ac­cess: In a glo­ba­li­zed mar­ket en­vi­ron­ment, a com­pa­ny with a cer­ti­fied QMS can de­mons­tra­te that qua­li­ty and pro­cess safe­ty are sys­te­ma­ti­cal­ly ad­dres­sed. In some in­dus­tries, such as the au­to­mo­ti­ve in­dus­try, such a cer­ti­fi­ca­te is a man­da­to­ry re­qui­re­ment for busi­ness transactions.
  • Bet­ter qua­li­ty at lower cost: Qua­li­ty ma­nage­ment en­su­res qua­li­ty as ear­ly as pos­si­ble in the de­ve­lo­p­ment pro­cess. Ear­ly de­tec­tion of de­fects is much more cost ef­fec­ti­ve com­pa­red to de­tec­tion du­ring fi­nal inspection.
  • Cost sa­vings: The com­pa­ny saves mo­ney by pro­du­cing less was­te. This re­du­ces the cost of purcha­sing raw ma­te­ri­als and dis­po­sing of waste.
  • Sys­te­ma­tic qua­li­ty thin­king among em­ployees: A QMS al­lows all em­ployees of a com­pa­ny (not only the qua­li­ty as­suran­ce ex­perts) to be in­vol­ved in qua­li­ty assurance.
  • Trans­pa­rent busi­ness pro­ces­ses: Ope­ra­tio­nal pro­ces­ses are do­cu­men­ted and de­scri­bed. This makes them trans­pa­rent and ea­sier to re­view for im­pro­ve­ment op­por­tu­nities. It also makes it ea­sier to iden­ti­fy and eli­mi­na­te problems.
  • Sus­tainab­le stan­dard: Qua­li­ty ma­nage­ment sys­tems help to se­cu­re the achie­ved op­ti­miz­a­ti­ons in the long term by ma­king the im­pro­ved pro­ce­du­res and pro­ces­ses “stan­dard prac­ti­ce” and thus the norm.
  • Bet­ter know-how trans­fer: Do­cu­men­ted and de­scri­bed work­flows and pro­ces­ses en­ab­le a more ef­fi­ci­ent and ef­fec­ti­ve trans­fer of ope­ra­tio­nal know-how. This makes it ea­sier to train new em­ployees, for example.

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