Illustration of the Rottendorf Pharma logo

A sweet pill to swallow 

“The d.velop Life Sci­ence team has sup­por­ted us for ye­ars in ma­king our pro­ces­ses more ef­fi­ci­ent and di­gi­tal. This way, we have been able to suc­cess­ful­ly im­ple­ment the GxP-com­pli­ant ma­nage­ment of do­cu­ments, em­ployee qua­li­fi­ca­ti­ons, and con­tracts tog­e­ther in our com­pa­ny over the past few ye­ars. We are hap­py to build on the po­si­ti­ve ex­pe­ri­en­ces with the d.velop Life Sci­ence team and cur­r­ent­ly have nu­me­rous pro­jects in the pipe­line that will make our do­cu­men­ta­ti­on more di­gi­tal, trace­ab­le and cen­tra­li­zed. d.velop Life Sci­ence GmbH is a strong and long-term part­ner for us.”

Darstellung des Logos von Rottendorf Pharma GmbH
Dr. Ni­co­le Freise-Papke
Pro­cess Group Lea­der QA-Sys­tems (Rot­ten­dorf Phar­ma GmbH)

Rottendorf Pharma digitizes document control and employee training with QMS d.3 life sciences

Di­gi­tiz­a­ti­on is not witch­craft. Ra­ther a ra­ther sweet pill, pro­ves Rot­ten­dorf Phar­ma. Sin­ce the ever-ad­van­cing use of di­gi­tal sys­tems, the phar­maceu­ti­cal com­pa­ny from En­niger­loh al­rea­dy saves a lar­ge num­ber of man-hours per year in em­ployee trai­ning alo­ne — thanks to the qua­li­ty ma­nage­ment sys­tem (QMS) d.3 life sciences.

Film-coated ta­blets, coated ta­blets and cap­su­les: Rot­ten­dorf Phar­ma is a phar­maceu­ti­cal ser­vice com­pa­ny ba­sed in En­niger­loh near Müns­ter that has spe­cia­li­zed in the de­ve­lo­p­ment, ma­nu­fac­tu­re and pa­ck­a­ging of phar­maceu­ti­cals in so­lid do­sa­ge form sin­ce 1928. A com­pa­ny on cour­se for growth. The phar­maceu­ti­cal spe­cia­list now em­ploys more than 1,200 peop­le. Howe­ver, this de­ve­lo­p­ment also po­ses or­ga­niz­a­tio­nal chal­len­ges for the com­pa­ny. For ex­amp­le, in the ma­nage­ment of so-cal­led Stan­dard Ope­ra­ting Pro­ce­du­res (SOP). The­se are in­st­ruc­tions that de­scri­be the stan­dar­di­zed hand­ling of pro­ces­ses — for cri­ti­cal are­as of the phar­maceu­ti­cal industry.

Man sitting in front of test tubes

“This red tape was really our largest pain point”

SOP ma­nage­ment cost Rot­ten­dorf Phar­ma time and ner­ves for ye­ars, be­cau­se it took place en­t­i­re­ly on pa­per. Em­ployees jug­gled over 900 in­st­ruc­tions with up to 40 at­tach­ments each. They wal­ked mi­les around the com­pa­ny to get si­gna­tures and pass the do­cu­ments on to col­leagues. They spent hours at the prin­ter and in ar­chi­ves when con­tent chan­ges were due. “This red tape de­ve­lo­ped into our lar­gest pain point,” re­calls Dr. Ni­co­le Frei­se-Pap­ke, Pro­cess Group Lea­der QA Sys­tems at Rot­ten­dorf Phar­ma. “To save re­sour­ces and ner­ves, we the­re­fo­re set out to find a spe­cia­list for di­gi­tiz­a­ti­on so­lu­ti­ons in the phar­maceu­ti­cal in­dus­try.” Rot­ten­dorf Phar­ma found what it was loo­king for with d.velop Life Sci­en­ces from Ge­scher near Münster.

Goodbye to miles of walking and wasted paper!

To sim­pli­fy the ma­nage­ment of SOP do­cu­ments, Rot­ten­dorf Phar­ma and d.velop Life Sci­en­ces have im­ple­men­ted a qua­li­ty ma­nage­ment sys­tem (QMS) cal­led d.3 life sci­en­ces. This is a plat­form that, thanks to its mo­du­lar struc­tu­re, grows fle­xi­b­ly with com­pa­nies and sim­pli­fies nu­me­rous tasks — around the clas­si­fi­ca­ti­on, struc­tu­ring, sto­rage, and ver­sio­ning of di­gi­tal in­for­ma­ti­on. At the he­art of the so­lu­ti­on at Rot­ten­dorf Phar­ma: the Do­cu­ment Con­trol mo­du­le. Em­ployees crea­te new SOPs with this mo­du­le. This is done much fas­ter than be­fo­re with the help of tem­pla­tes. The re­view, ap­pro­val and re­lease cy­cle is also ac­ce­le­ra­ted. It is now also per­for­med wi­t­hin the QMS. Si­gna­tures are no lon­ger ap­p­lied on pa­per, but elec­tro­ni­cal­ly. Ki­lo­me­ters of wal­king bet­ween de­part­ments are now a thing of the past. The same ap­p­lies to was­ted pa­per, which is a gre­at pain for more and more com­pa­nies in times of sus­tainab­le busi­ness. Mo­reo­ver, the soft­ware en­su­res transparency

“Thanks to d3.life sciences, we gain full transparency in the qualification level of employees”

The on­boar­ding for new SOPs is also ac­ce­le­ra­ted. When a new in­st­ruc­tion is cir­cu­la­ted, em­ployees re­cei­ve a mes­sa­ge as­king them to stu­dy the do­cu­ment. If they con­firm that they have read and un­ders­tood ever­ything, a green check mark ap­pears in a qua­li­fi­ca­ti­on ma­trix. “When it co­mes to SOP ma­nage­ment, we are now com­ple­te­ly pa­per­less thanks to the di­gi­tiz­a­ti­on so­lu­ti­on,” says Ms. Frei­se-Pap­ke. “As a re­sult, we gain full trans­pa­ren­cy on the qua­li­fi­ca­ti­on le­vel of em­ployees much fas­ter than be­fo­re. And that’s wi­thout prin­ted pa­per or con­fu­sing Ex­cel spreads­he­ets.” In the fu­ture, Rot­ten­dorf Phar­ma will the­re­fo­re also be di­gi­ti­zing other ty­pes of do­cu­ments — again in clo­se coope­ra­ti­on with the ex­perts from Ge­scher. “We appre­cia­te how much d.velop Life Sci­en­ces stri­ves to find the best pos­si­ble and tailo­red so­lu­ti­on for our needs. That’s not so­me­thing to take for granted.”

Illustration of a microscope and a pipette

Digitization of GMP training saves 120 hours of work per year

Rot­ten­dorf Phar­ma is on cour­se for di­gi­tiz­a­ti­on. And es­tab­lis­hes the first com­pa­ny-wide e‑learning for so-cal­led Good Ma­nu­fac­tu­ring Prac­ti­ce (GMP) trai­ning.

In the past, GMP se­mi­nars were held re­gu­lar­ly in of­fices, and the do­cu­men­ta­ti­on of trai­ning and test re­sults was done la­bo­rious­ly by hand. To­day, the who­le pro­gram ta­kes place in the di­gi­tal sphe­re. This is made pos­si­ble by the la­test buil­ding block in Rot­ten­dorf Pharma’s di­gi­ta­liz­a­ti­on tool­box: e‑learning — a mo­du­le for di­gi­tal trai­ning of em­ployees. In­s­tead of tra­di­tio­nal class­room in­st­ruc­tion, em­ployees use the mo­du­le to crea­te e‑learnings on va­rious to­pics, such as pro­ce­du­res in do­cu­men­ta­ti­on prac­ti­ce or hy­gie­nic hand wa­shing. Do­cu­ments, au­dio files and vi­de­os to il­lus­tra­te the lear­ning con­tent can be in­te­gra­ted with just a few clicks. The mo­du­le can also be used to de­sign a fi­nal exam in an equal­ly time-sa­ving man­ner — in­clu­ding ele­ments such as text an­s­wers, clo­ze texts or puzzles.

QA em­ployees then pro­vi­de the pre­pa­red e‑learnings and the fi­nal ex­ams to their col­leagues from the re­spec­ti­ve de­part­ments via the task in­box. Ha­ving pas­sed the ex­ams, the soft­ware au­to­ma­ti­cal­ly up­dates the team member’s qua­li­fi­ca­ti­on le­vel in the qua­li­fi­ca­ti­on ma­trix. This al­lows to see at a glance if only em­ployees who have been de­mons­tra­b­ly suc­cess­ful­ly trai­ned are per­forming the re­le­vant ac­ti­vi­ties. “By im­ple­men­ting e‑learning for com­pa­ny-wide GMP trai­ning, we save about 120 man-hours per year,” ex­p­lains Dr. Frei­se-Pap­ke. “Af­ter this suc­cess­ful pi­lot pro­ject, we the­re­fo­re want to di­gi­ti­ze even more com­pa­ny-wide trai­ning in the future.”

Learn more about the E‑Learning software solution

Get a ho­listic over­view of our ver­sa­ti­le E‑Learning so­lu­ti­on now. 
Illustration of a notebook on which the e-learning of d.velop Life Sciences is displayed