Logo Amann Girrbach

Digital GxP-compliant technical documentation for medicinal products

“Fo­re­most, the fle­xi­bi­li­ty spo­ke for the d.velop so­lu­ti­on. From the very be­gin­ning, we could have the do­cu­ment ma­nage­ment sys­tem cus­to­mi­zed to our ex­pec­ta­ti­ons, ma­king it 100 per­cent sui­ta­ble for our pur­po­ses. Other ven­dors could not de­li­ver this in the same way.”

Darstellung des Logos von Amann Girrbach
Phil­ipp Wildgrube
Re­gu­la­to­ry Af­fairs Ma­na­ger at Amann Girrbach

Amann Girrbach

The Ger­man-Aus­tri­an en­ter­pri­se Amann Girr­bach sells me­di­cal pro­ducts glo­bal­ly. The cul­tures may be dif­fe­rent but all na­ti­ons have one thing in com­mon: Me­di­cinal pro­ducts must be flaw­less. Thus, Amann Girr­bach does not only have to en­su­re the ex­cel­lent qua­li­ty of its pro­ducts and ser­vices but the en­ter­pri­se also has to com­ply with the ju­s­ti­fia­bly high re­qui­re­ments of the re­spec­ti­ve re­gu­la­to­ry aut­ho­ri­ties. And the­se re­qui­re­ments have grown for years.

With more than 430 em­ployees world­wi­de, Amann Girr­bach ma­nu­fac­tures 10 pro­duct groups and the­r­e­fo­re has to do­cu­ment hundreds of work steps, re­cipes, mix­tu­re ra­ti­os, pro­ce­du­res and me­a­su­res for the qua­li­ty assu­rance. And this for va­rious aut­ho­ri­ties in dif­fe­rent count­ries. The tech­ni­cal do­cu­men­ta­ti­on must meet the gui­de­lines for good prac­ti­ce known un­der the key­word “GxP”.

In Ger­ma­ny, for ex­am­p­le, the TÜV Süd is va­li­da­ting me­di­cinal pro­ducts as well as the De­kra or the TÜV Nord. In the USA, the Food and Drug Ad­mi­nis­tra­ti­on (FDA) su­per­vi­ses the qua­li­ty of food and me­di­cinal pro­ducts with com­pa­ra­ble aut­ho­ri­ties in other count­ries. Dif­fe­rent coun­try, dif­fe­rent forms, dif­fe­rent re­qui­re­ments — and a high ef­fort for Amann Girr­bach to be able to of­fer va­rious me­di­cinal pro­ducts world­wi­de. Espe­ci­al­ly, as the tech­ni­cal do­cu­men­ta­ti­on has been con­duc­ted on pa­per in the past.

Picture of the headquarters of Amann Girrbach

Keeping the technical documentation for medicinal products up-to-date

“We are working on two pre­mi­ses in Kob­lach, Aus­tria and in Pforz­heim [Ger­ma­ny, the edi­tor]”, Phil­ipp Wild­gru­be, Re­gu­la­to­ry Af­fairs Ma­na­ger at Amann Girr­bach sta­tes. “Over time, it be­ca­me more and more chal­len­ging to keep the tech­ni­cal do­cu­men­ta­ti­on up-to-date.” Mo­reo­ver: “Using re­gu­lar mail, do­cu­ments took a long time to get from one site to the next.”

Fur­ther­mo­re, Amann Girr­bach loo­ked for part­ner for the di­gi­tal im­ple­men­ta­ti­on of their tech­ni­cal do­cu­men­ta­ti­on. The sys­tem had to be fle­xi­ble and cus­to­mizable by the user. Ad­di­tio­nal­ly, the soft­ware ven­dor should have ex­ten­si­ve know-how in the GxP sector.

On the trade fair Con­trol in Stutt­gart, Amann Girr­bach be­ca­me awa­re of the do­cu­ment ma­nage­ment sys­tem d.velop do­cu­ments (form­er­ly d.3ecm) of d.velop AG. It al­lows en­ter­pri­ses to quick­ly and ef­fec­tively di­gi­ti­ze their in­for­ma­ti­on and pro­ces­ses. The do­cu­ment ma­nage­ment sys­tem can be­co­me a cen­tral sto­rage lo­ca­ti­on for all in­for­ma­ti­on and do­cu­ments in the com­pa­ny while the in­dus­try-spe­ci­fic and GxP-com­pli­ant ad­di­tio­nal mo­du­les and ser­vices of the Di­gi­tal Life Sci­en­ces suc­cessful­ly ad­just it to the in­di­vi­du­al re­qui­re­ments of Amann Girrbach.

GxP-compliant documentation solution

Di­gi­tal Life Sci­en­ces GmbH is the com­pe­tence cen­ter of d.velop AG for GxP-com­pli­ant do­cu­ment so­lu­ti­ons and for elec­tro­nic qua­li­ty ma­nage­ment so­lu­ti­ons.   With about 60 em­ployees, the Di­gi­tal Life Sci­en­ces sup­ports more than 130 cus­to­mers, the ma­jo­ri­ty of which is working in the va­li­da­ted GxP sec­tor, e.g. in me­di­cal tech­no­lo­gy or the phar­maceu­ti­cal industry.

Espe­ci­al­ly com­pa­nies in the me­di­cal field have to think more and more about the tech­ni­cal do­cu­men­ta­ti­on of their pro­ducts. For ye­ars now, the re­gu­la­to­ry re­qui­re­ments of le­gis­la­tors and test­ing aut­ho­ri­ties have been gro­wing here. Here, the do­cu­ment ma­nage­ment sys­tem helps to keep on top of things. Amann Girr­bach be­ne­fi­ted from this.

Flexible ECM solution for the pharmaceutical industry

“Fo­re­most, the fle­xi­bi­li­ty spo­ke for the d.velop so­lu­ti­on”, Phil­ipp Wild­gru­be il­lus­tra­tes. “From the very be­gin­ning, we could have the do­cu­ment ma­nage­ment sys­tem cus­to­mi­zed to our ex­pec­ta­ti­ons, ma­king it 100 per­cent sui­ta­ble for our pur­po­ses. Other ven­dors could not de­li­ver this in the same way.” The re­qui­re­ments in­cluded be­ing able to im­ple­ment the struc­tu­re of Amann Girrbach’s tech­ni­cal documentation.

In 2015, Amann Girr­bach and the Di­gi­tal Life Sci­en­ces star­ted the com­mon pro­ject and be­gan to in­stall the do­cu­ment ma­nage­ment sys­tem, op­ti­mi­zing pro­ces­ses and di­gi­tiz­ing in­for­ma­ti­on. In­iti­al suc­ces­ses quick­ly be­ca­me ap­pa­rent, and with the le­gal frame­work con­stant­ly chan­ging, the­re is al­ways work to ad­apt. One of the dri­ving forces be­hind this was the new Eu­ro­pean Me­di­cal De­vices Re­gu­la­ti­on (MDR) of the year 2017.

Technical documentation 2.0

The re­qui­re­ments that re­gu­la­to­ry aut­ho­ri­ties place on me­di­cal com­pa­nies are va­ried and in some ca­ses con­sidera­ble. Among them are ori­gi­nal do­cu­ment that must not be ch­an­ged any more af­ter they have been re­leased. “Our soft­ware can im­ple­ment this,” says Frank Lau­mann, Head of Ser­vice and aut­ho­ri­zed re­pre­sen­ta­ti­ve at Di­gi­tal Life Sci­en­ces. The Di­gi­tal Life Sci­en­ces cli­ent now al­lows Amann Girr­bach to se­cu­re­ly im­ple­ment their GxP processes.

The be­ne­fits of the soft­ware include:

  • Com­pre­hen­si­ve di­gi­tal ma­nage­ment of the dossier
  • Di­gi­tal crea­ti­on and up­date of the tech­ni­cal do­cu­men­ta­ti­on wi­thin the re­qui­re­ments of the Me­di­cal De­vice Regulation
  • Ma­king clut­te­red file ser­vers with red­un­dant­ly stored co­pies and fol­der struc­tures a mat­ter of the past
  • Mi­ni­mi­zing pro­cess run­times for the crea­ti­on, re­vi­si­on and re­lease of dossiers
  • Ver­sio­ning of the dossier
  • Ex­port of the en­ti­re dossier
  • Che­cking the dos­sier for completeness

“The in­for­ma­ti­on is now sen­si­bly and lo­gi­cal­ly struc­tu­red,” Phil­ipp Wild­gru­be sta­tes, “that was nice and easy with and from d.velop. The soft­ware al­lows us to im­ple­ment al­most any­thing you like.” One of the grea­test ad­van­ta­ges of the GxP-com­pli­ant di­gi­tal do­cu­ment ma­nage­ment sys­tem lies in the fast ac­cess times. No em­ployee is forced to brow­se th­rough pi­les of pa­per any more or search in the mail­bo­xes. Lau­mann: “In­for­ma­ti­on can be found quicker, all em­ployees nee­ding ac­cess have one cen­tral point of entry.”

Support team and contact persons

Fast ac­cess to in­for­ma­ti­on is one of Amann Girrbach’s most si­gni­fi­cant re­qui­re­ments with a GxP-com­pli­ant do­cu­ment ma­nage­ment sys­tem. “The big ad­van­ta­ge of the d.velop pro­ducts is that we can quick­ly and ea­si­ly ac­cess do­cu­ments.”, Wild­gru­be de­scri­bes. He con­ti­nues: “We are ful­ly sa­tis­fied with the working pro­ce­du­res of the sys­tem and with the sup­port team.”

Project partners

Sin­ce 2007, Di­gi­tal Life Sci­en­ces GmbH is the Com­pe­tence Cen­ter of d.ve­lop AG for GxP-com­pli­ant do­cu­men­ta­ti­on so­lu­ti­ons. Thi­lo Gu­kel­ber­ger, one of the co-foun­ders of the d.velop AG, ma­na­ges the com­pa­ny along with other long-term em­ployees of d.velop AG. Thus, we are si­gni­fi­cant co-in­ven­tors of the ba­sic pro­duct d.velop do­cu­ments (form­er­ly d.3ecm) which is me­an­while used as a cen­tral ECM/DMS ar­chi­ve sys­tem by more than 12,500 users glo­bal­ly. The so­lu­ti­ons by the Di­gi­tal Life Sci­en­ces GmbH are to be un­ders­tood as com­ple­men­ta­ry ad­di­ti­ons to d.velop do­cu­ments (form­er­ly d.3ecm). They pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses of manufacturing/production and the qua­li­ty ma­nage­ment. In ad­di­ti­on to our cus­to­mers of the clas­si­cal Life Sci­en­ces in­dus­try (phar­maceu­ti­cal, me­di­cal tech­no­lo­gy, food sup­ple­ments, cos­me­tics), also cus­to­mers from the steel in­dus­try and the ser­vice sec­tor trust the so­lu­ti­ons of the Di­gi­tal Life Sci­en­ces GmbH.

Learn more about technical documentation

Get a ho­li­stic over­view of our MDR-com­pli­ant so­lu­ti­on now.

Illustration of a notebook on which the technical documentation of Digital Life Sciences is displayed