Representation of the logo of Lichtenheldt GmbH

“We strive for sustainable growth”

“With its d.3 life sci­en­ces sys­tem, d.velop Life Sci­en­ces GmbH hel­ps us to stra­te­gi­cal­ly de­ve­lop our QMS and to map elec­tro­nic so­lu­ti­ons / work­flows in con­si­de­ra­ti­on of GMP and ISO re­qui­re­ments. The mo­du­les “Do­cu­ment Con­trol”, “Em­ployee Qua­li­fi­ca­ti­on Ma­nage­ment”, “De­via­ti­on Con­trol” and “CAPA” are cur­r­ent­ly im­ple­men­ted and the ERP sys­tem is in­te­gra­ted on the in­ter­face side in or­der to be able to use the exis­ting pro­cess in­for­ma­ti­on across sys­tems. Due to the va­rious pos­si­bi­li­ties and the con­ti­nuous func­tio­n­al en­han­ce­ments in the d.3 life sci­en­ces sys­tem, we are al­rea­dy loo­king for­ward to many ex­ci­ting fu­ture pro­jects, be it for the in­tro­duc­tion of fur­ther do­cu­ment ty­pes or of new mo­du­les in or­der to be able to suc­cess­ful­ly fur­ther in­cre­a­se our ef­fi­ci­en­cy and make our do­cu­men­ta­ti­on more di­gi­tal, trace­ab­le and centralized.”

Darstellung des Logos von Lichtenheldt GmbH
Mar­cel Rau
IT ap­p­li­ca­ti­on (LICHTENHELDT GmbH)

Good­bye pa­per co­pies: The phar­maceu­ti­cal ma­nu­fac­tu­rer Lich­ten­heldt di­gi­ta­li­zes its do­cu­ment ma­nage­ment with the d.3 eQMS sys­tem of d.velop Life Sci­en­ces GmbH. Why the com­pa­ny not only streng­t­hens en­vi­ron­men­tal pro­tec­tion, but also saves time and money.

J. N. Lich­ten­heldt would have been ama­zed: 276 ye­ars af­ter he foun­ded the phar­maceu­ti­cal com­pa­ny Lich­ten­heldt in 1745, the com­pa­ny is one of the pioneers in the de­ve­lo­p­ment and pro­duc­tion of li­quid and semi-so­lid phar­maceu­ti­cal and me­di­cal pro­ducts. With around 250 em­ployees, the plant fills and pa­cka­ges more than six mil­li­on li­ters a year in over 30 mil­li­on in­di­vi­du­al con­tai­ners. The task is to keep track of over 150 re­ci­pes. And much more: Stan­dard Ope­ra­ting Pro­ce­du­res (SOP), work in­st­ruc­tions that de­scri­be work pro­ces­ses in such de­tail that the­re is no room for in­ter­pre­ta­ti­on for users.

A mam­mo­th task that de­man­ded a lot of en­er­gy and ex­pen­se from Lich­ten­heldt in the past be­cau­se it was still roo­ted in the ana­log world. “We wro­te new work in­st­ruc­tions on the com­pu­ter, then prin­ted them out with at­tach­ments, ob­tai­ned si­gna­tures from tho­se re­spon­si­ble, scan­ned do­cu­ments back in and do­cu­men­ted all pro­ces­ses in Ex­cel lists,” re­calls Mar­cel Rau, IT ap­p­li­ca­ti­on at Lich­ten­heldt. This not only cost time, but also re­sour­ces such as pa­per and prin­ter to­ner. Ad­di­tio­nal pres­su­re has come from the sup­ply chain, whe­re more and more par­ti­ci­pants want di­gi­ta­liz­a­ti­on in qua­li­ty ma­nage­ment. “We stri­ve for per­ma­nent im­pro­ve­ment and sus­tainab­le growth so that our com­pa­ny can sur­vi­ve in an ever-chan­ging busi­ness world. That’s why we de­ci­ded to di­gi­ta­li­ze the SOP management.”

The d.3 eQMS system of d.velop Life Sciences GmbH makes paper superfluous and accelerates work processes

In or­der to get rid of pa­per and trans­fer qua­li­ty ma­nage­ment to the di­gi­tal world, Lich­ten­heldt has in­stal­led a new ERP sys­tem and in­tro­du­ced the do­cu­ment and qua­li­ty ma­nage­ment sys­tem of d.velop Life Sci­en­ces.  The ba­sis of the d.3 life sci­ence sys­tem is a ho­listic ECM/DMS sys­tem, which can be mo­du­lar­ly ex­ten­ded by fur­ther d.velop pro­ducts around clas­si­fi­ca­ti­on, struc­tu­ring, sto­rage and ver­sio­ning of in­for­ma­ti­on. The fo­cus at Lich­ten­heldt is on the do­cu­ment con­trol mo­du­le. In­s­tead of prin­ting out SOP and at­tach­ments, the com­pa­ny stores do­cu­ments in a cen­tral da­ta­ba­se that all em­ployees can ac­cess. The ad­van­ta­ge of this sto­rage: col­leagues al­ways work with up-to-date do­cu­ments. It is im­pos­si­ble to have dif­fe­rent ver­si­ons floa­ting around, causing con­fu­si­on and er­ror-pro­neness. Rau: “With the d.3 eQMS sys­tem, howe­ver, we not only in­cre­a­se trans­pa­ren­cy and se­cu­ri­ty, but also ac­ce­le­ra­te the working pro­ces­ses around new SOP.”

The fol­lowing ex­amp­le shows why the d.3 eQMS from d.velop Life Sci­en­ces im­pro­ves SOP ma­nage­ment: A new SOP in qua­li­ty con­trol is on the agen­da. An em­ployee wri­tes the do­cu­ment in Word. In­s­tead of run­ning to get si­gna­tures of the re­spon­si­ble per­sons af­ter­wards, he saves the file in the da­ta­ba­se of d.3 eQMS sys­tems. When edi­t­ing is com­ple­te, a pre­de­fi­ned do­cu­ment cir­cu­la­ti­on starts au­to­ma­ti­cal­ly. The first thing the la­bo­ra­to­ry ma­na­ger sees then, for ex­amp­le, is a mes­sa­ge in his d.3 life sci­en­ces mail­box — with the re­quest to check the do­cu­ment for cor­rect­ness of con­tent and to con­firm the re­view with a si­gna­tu­re. Sin­ce a ma­nu­al si­gna­tu­re is no lon­ger pos­si­ble, two-way au­then­ti­ca­ti­on co­mes into play. The la­bo­ra­to­ry ma­na­ger uses one pass­word to log into the sys­tem and ano­t­her to place his di­gi­tal si­gna­tu­re on the document.

Af­ter this elec­tro­nic si­gna­tu­re, the au­to­ma­ted cir­cu­la­ti­on con­ti­nues. Now the qua­li­ty con­trol ma­na­ger finds a mes­sa­ge in his mail­box as­king him to ap­pro­ve the new SOP. In the fi­nal sta­ge, this SOP is re­leased by the head of qua­li­ty as­suran­ce. Step by step, the work in­st­ruc­tion thus finds its way through a pre­de­fi­ned, pu­re­ly di­gi­tal ap­pro­val pro­cess. “Thanks to this di­gi­ta­liz­a­ti­on, we have ma­na­ged to save time and re­sour­ces while ma­king pro­ces­ses more secure.”

The d.3 life sciences system also automates employee qualification management

Lich­ten­heldt uses the d.3 eQMS sys­tem not only for SOP ma­nage­ment, but also for em­ployee qua­li­fi­ca­ti­on ma­nage­ment (EQM). In the past, em­ployees also worked here with Ex­cel lists, with which they do­cu­men­ted do­cu­ments and trai­ning cour­ses. Also an ela­bo­ra­te job. To­day, the sys­tem au­to­ma­ti­cal­ly ge­ne­ra­tes trai­ning re­qui­re­ments af­ter the SOP is ap­pro­ved. In do­ing so, it knows exact­ly which em­ployees need to be in­st­ruc­ted. The­se re­cei­ve a mes­sa­ge in their d.3 life sci­en­ces mail­box as­king them to stu­dy the do­cu­ment and take a short on­line test. An ex­ami­na­ti­on that can also be crea­ted with the d.velop Life Sci­en­ces soft­ware. “We have over 250 em­ployees that we have to train re­gu­lar­ly, once a year for ex­amp­le on per­so­nal hy­gie­ne. In the past, we had to hold the trai­ning cour­ses and ex­ams as class­room events, which re­qui­red a lot of pre­pa­ra­ti­on”, says Rau. “To­day, em­ployees can com­ple­te the trai­nings at their fa­vo­ri­te time, even in their home of­fice. This me­ans an enor­mous time sa­ving for us. The sys­tem even ta­kes care of do­cu­men­ting the trai­ning re­sults for us.”

Complaint management is also digitalized and accelerated

An ex­amp­le: A cus­to­mer com­p­lains that the pa­cka­ge in­sert is mis­sing from a fol­ding box. A qua­li­ty as­suran­ce em­ployee re­cei­ves the com­p­laint and do­cu­ments the in­ci­dent in the De­via­ti­on Con­trol (DC) mo­du­le. The sys­tem then au­to­ma­ti­cal­ly sends a re­quest to va­rious de­part­ments in the com­pa­ny to per­form a risk as­sess­ment, for ex­amp­le — in other words, to esti­ma­te the pro­ba­bi­li­ty that such a case could oc­cur a se­cond time. If the pro­ba­bi­li­ty is gi­ven, pre­ven­ti­ve and cor­rec­ti­ve ac­tions (CAPA) can be trig­ge­red via the sys­tem, such as the in­tro­duc­tion of a belt weig­her that can in­fer an in­com­ple­te pa­cka­ge from the weight.

 “The­se are all steps that used to be done on pa­per and now work fas­ter and more se­cu­re­ly thanks to di­gi­ta­liz­a­ti­on”, ex­p­lains Rau, who is also con­vin­ced by the coope­ra­ti­on with d.velop. “The col­la­bo­ra­ti­on was re­al­ly pro­duc­ti­ve and fun. We ex­pe­ri­men­ted with au­to­ma­ted work­flows tog­e­ther, tes­ted them in day-to-day ope­ra­ti­ons, and kept fine-tu­ning them un­til the pro­ces­ses fi­nal­ly worked. In do­ing so, d.velop Life Sci­en­ces has al­ways worked ac­cord­ing to the princip­le of hel­ping peop­le to help them­sel­ves. Af­ter a short time, we felt fit en­ough to ope­ra­te and fur­ther de­ve­lop the sys­tem wi­thout support.”

Learn more about the Document Control

Get a ho­listic over­view of our ver­sa­ti­le soft­ware Do­cu­ment Con­trol now. 
Illustration of a notebook on which the document control of d.velop Life Sciences is displayed