Representation of the logo of Aristo Pharma

Transparency across site boundaries

“The in­tro­duc­tion of a DMS in­clu­ding Con­trol­led Do­cu­ments and Trai­ning Ma­nage­ment for our en­ti­re group of com­pa­nies with a to­tal of six ger­man lo­ca­ti­ons was gl­ad­ly ac­cept­ed as a gre­at chall­enge on the part of Di­gi­tal Life Sci­en­ces and was mas­te­red pro­fes­sio­nal­ly and on sche­du­le. The very good pre­pa­ra­ti­on by Di­gi­tal Life Sci­en­ces hel­ped us to im­ple­ment the mo­du­les in a very short time. The ac­cep­tance of the em­ployees can be seen as a pro­of for the suc­cess of the im­ple­men­ta­ti­on. We are al­re­a­dy loo­king for­ward to fur­ther co­ope­ra­ti­on in the in­tro­duc­tion of fur­ther mo­du­les (Ch­an­ge Con­trol, De­via­ti­on Con­trol, CAPA) in or­der to fur­ther suc­cessful­ly in­crease our efficiency.”

Darstellung des Logos von Aristo Pharma
Dr. Cor­ne­lia Beier
Head of Qua­li­ty Ma­nage­ment (Aris­to Phar­ma GmbH)

Pharmaceutical manufacturer Aristo Pharma creates central document management with dls | eQMS

Phar­maceu­ti­cal ma­nu­fac­tu­rer Aris­to Phar­ma ma­na­ges mil­li­ons of in­voices as well as pro­cess de­scrip­ti­ons, ma­nu­fac­tu­ring and test spe­ci­fi­ca­ti­ons, and con­tracts with the do­cu­ment ma­nage­ment sys­tem dls | eQMS by Di­gi­tal Life Sci­en­ces, thus crea­ting trans­pa­ren­cy across the boun­da­ries of the six Ger­man locations.

The ori­gi­nal drug is too ex­pen­si­ve for you? For­t­u­na­te­ly, a ge­ne­ric pro­duct is most li­kely available — a so-cal­led ge­ne­ric pro­duct made from an off-pa­tent ac­ti­ve in­gre­di­ent that is of­fe­red as an af­forda­ble al­ter­na­ti­ve by an­o­ther ma­nu­fac­tu­rer. Aris­to Phar­ma — a Ber­lin-ba­sed com­pa­ny that emer­ged in 2008 from the mer­ger of se­ve­ral me­di­um-si­zed Ger­man phar­maceu­ti­cal com­pa­nies — spe­cia­li­zes in the pro­duc­tion of such drugs, which are high-qua­li­ty yet cost-ef­fec­ti­ve. A com­pa­ny with a growth-ori­en­ted path, which the more than 1,800 em­ployees en­thu­si­a­sti­cal­ly help to shape.

In­cre­asing­ly im­portant on the road to suc­cess: smooth work­flows and trans­pa­ren­cy across the boun­da­ries of in­di­vi­du­al sites. Ana­log data car­ri­ers such as pa­per are ba­re­ly kee­ping pace. The ma­nage­ment of mil­li­ons of prin­ted in­voices as well as pro­cess de­scrip­ti­ons, ma­nu­fac­tu­ring and test spe­ci­fi­ca­ti­ons, and con­tracts be­co­mes a test of en­du­rance for de­part­ments and a stop­per for the com­pa­ny. Aris­to Phar­ma was the­r­e­fo­re loo­king for a cen­tral di­gi­tiza­ti­on so­lu­ti­on. The phar­maceu­ti­cal com­pa­ny found what it was loo­king for at Di­gi­tal Life Sci­en­ces, a spe­cia­list from Ge­scher near Müns­ter, which ser­ves around 130 cus­to­mers, the ma­jo­ri­ty of whom are ac­ti­ve in me­di­cal tech­no­lo­gy or in the phar­maceu­ti­cal environment.

dls | eQMS enables central and digital document management

Aris­to Phar­ma opted for the qua­li­ty ma­nage­ment sys­tem (QMS) dls | eQMS. The QMS plat­form is the tech­no­lo­gi­cal ba­sis of num­e­rous d.velop pro­ducts around the clas­si­fi­ca­ti­on, struc­tu­ring, sto­rage and ver­sio­ning of in­for­ma­ti­on — a kind of frame­work for mo­du­les al­lo­wing com­pa­nies to paint their in­di­vi­du­al di­gi­tiza­ti­on pic­tu­re. “We cho­se Di­gi­tal Life Sci­en­ces be­cau­se with dls | eQMS we en­joy ma­xi­mum op­ti­ons when it co­mes to di­gi­ta­liza­ti­on,” em­pha­si­zes Dr. Cor­ne­lia Bei­er, Head of Qua­li­ty Ma­nage­ment at Aris­to Phar­ma. “We don’t need new soft­ware and in­ter­faces for every work­flow, but can map ever­y­thing with a sin­gle sys­tem and save time and ner­ves on a day-to-day basis.”

Gu­ten­berg would have been ama­zed: With dls | eQMS, Aris­to Phar­ma will soo­ner or la­ter say good­bye to pa­per. Pre­vious­ly, the sites prin­ted out all do­cu­ments — in­clu­ding work and pro­cess in­s­truc­tions, pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons, ope­ra­ting in­s­truc­tions and con­tracts. Mil­li­ons of prin­ted do­cu­ments fil­led the ar­chi­ves. Not only a was­te of space, but also a was­te of time. If em­ployees wan­ted to work with a do­cu­ment, they first had to search for the po­si­ti­on in the ar­chi­ve using an Ex­cel spreadsheet. This was fol­lo­wed by wal­king, and on site, sig­ning in and out of wi­th­dra­wals — much like a li­bra­ry. All the­se steps un­neces­s­a­ri­ly was­ting time. Dr. Bei­er: “To save this time, we in­tro­du­ced the Do­cu­ment Con­trol module.”

In the fu­ture, Aris­to Phar­ma will store all do­cu­ments in di­gi­tal form — in dls | eQMS as a cen­tral in­for­ma­ti­on plat­form. With the Do­cu­ment Con­trol mo­du­le, em­ployees can now find mil­li­ons of fol­ders and do­cu­ments in se­conds using a smart search func­tion that al­lows fil­te­ring by at­tri­bu­tes such as sta­tus and fil­ing date while also sear­ching full text. An aut­ho­riza­ti­on ma­nage­ment is used to de­ter­mi­ne which em­ployees may sub­se­quent­ly ac­cess which do­cu­ments. The Do­cu­ment Con­trol mo­du­le now also pro­vi­des a di­gi­tal re­view, ap­pr­oval and re­lease cy­cle wi­t­hout ana­log signatures.

“Employees feel relieved of tedious routine tasks”

Working with the di­gi­tal do­cu­ments is just as easy as fin­ding them. dls | eQMS com­bi­nes files that be­long tog­e­ther into di­gi­tal fol­ders via in­di­vi­du­al­ly cus­to­mizable at­tri­bu­te fields — si­mi­lar to a clas­sic pa­per ar­chi­ve, but wi­t­hout its di­s­ad­van­ta­ges. For ex­am­p­le, the same do­cu­ment may exist in a cus­to­mer fol­der and an or­der fol­der at the same time, sin­ce a di­gi­tal fol­der only re­fe­ren­ces a do­cu­ment, un­li­ke the pa­per ar­chi­ve. An­o­ther ad­van­ta­ge is that the Do­cu­ment Con­trol mo­du­le can be used to au­to­ma­te tasks such as do­cu­ment dis­tri­bu­ti­on and si­gna­tu­re cir­cu­la­ti­on. A func­tion that sa­ves a lot of wal­king. “The new so­lu­ti­on is cor­re­spon­din­gly well re­cei­ved by our em­ployees,” Dr. Bei­er is plea­sed to say. “Em­ployees feel re­li­e­ved of te­dious rou­ti­ne tasks and save re­sour­ces for more thril­ling tasks.”

Time-saving contract management

Aris­to Phar­ma also used the con­tract ma­nage­ment soft­ware to ar­chi­ve thou­sands of con­tracts, in­clu­ding li­cen­se agree­ments and non-dis­clo­sure agree­ments, from six sites in a cen­tral di­gi­tal pool. Here, the com­pa­ny was al­re­a­dy using a di­gi­tiza­ti­on so­lu­ti­on. Aris­to has cho­sen the Con­tract Ma­nage­ment mo­du­le in or­der to work in one sys­tem for the en­ti­re do­cu­ment ma­nage­ment, com­bi­ned with many new and con­ve­ni­ent func­tion­a­li­ties. If de­si­red, the mo­du­le can re­mind Aris­to Phar­ma of im­portant dead­lines automatically.

Me­an­while mo­reo­ver, about 1.2 mil­li­on in­voice do­cu­ments have also been trans­fer­red to the long-term sto­rage of dls | eQMS via an in­ter­face to SAP. “This is au­dit-pro­of ar­chi­ving that meets all le­gal re­qui­re­ments — in­clu­ding com­ple­ten­ess, avai­la­bi­li­ty, ac­cess pro­tec­tion and re­ten­ti­on pe­ri­ods,” ex­plains Dr. Bei­er. “With this new ar­chi­ving, we have laid the foun­da­ti­on for sus­tainable com­pli­ant work.”

The qualification management is also digitized

And the di­gi­tiza­ti­on jour­ney con­ti­nues. In the cour­se of the di­gi­tal trans­for­ma­ti­on, Aris­to Phar­ma has de­ci­ded to also im­ple­ment the qua­li­fi­ca­ti­on ma­nage­ment of em­ployees elec­tro­ni­cal­ly — with the soft­ware mo­du­le “Trai­ning Ma­nage­ment”. Whe­re­as qua­li­ty ma­nage­ment staff used to have to copy new spe­ci­fi­ca­ti­ons such as stan­dard ope­ra­ting pro­ce­du­res (SOPs) ump­teen times for up­co­ming trai­ning ses­si­ons, dis­tri­bu­te them with trai­ning sheets to the are­as to be trai­ned, and then do­cu­ment the test re­sults in Ex­cel lists, the pro­cess is now car­ri­ed out en­ti­re­ly in the soft­ware. The­re, sub­ject mat­ter ex­perts sel­ect the em­ployees to be trai­ned and send them di­gi­tal in­for­ma­ti­on ma­te­ri­als and in­di­vi­du­al ques­ti­on­n­aires. “Em­ployees then sit the exam wi­thin the soft­ware. All re­sults are au­to­ma­ti­cal­ly do­cu­men­ted in a qua­li­fi­ca­ti­on ma­trix, and the qua­li­fi­ca­ti­on le­vel of hundreds of em­ployees can be seen at a glan­ce,” says Dr. Bei­er. “This so­lu­ti­on also re­li­e­ves us of stre­nuous rou­ti­ne tasks and crea­tes re­sour­ces that we can in­vest in more im­portant tasks.”

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