Illustration of the Aristo Pharma logo

Transparency across site boundaries

“The in­tro­duc­tion of a DMS incl. the GMP mo­du­les Con­trol­led Do­cu­ments and EQM for our en­t­i­re group of com­pa­nies at the six Ger­man lo­ca­ti­ons was glad­ly ac­cep­ted as a gre­at chal­len­ge on the part of d.velop Life Sci­en­ces and was even­tual­ly mas­te­red on sche­du­le and pro­fes­sio­nal­ly. The very good pre­pa­ra­ti­on by d.velop Life Sci­en­ces hel­ped us to im­ple­ment the mo­du­les in a very short time. The em­ployees’ ac­cep­t­ance pro­ves the suc­cess of the in­tro­duc­tion. We are al­rea­dy loo­king for­ward to fur­ther col­la­bo­ra­ti­on on the in­tro­duc­tion of ad­di­tio­nal mo­du­les (Chan­ge Con­trol, De­via­ti­on, CAPA) 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 d.3 life sciences

Phar­maceu­ti­cal ma­nu­fac­tu­rer Aris­to Phar­ma ma­na­ges mil­li­ons of in­voices as well as pro­cess de­scrip­ti­ons, ma­nu­fac­tu­ring and test spe­ci­fi­ca­ti­ons, and con­tracts with the do­cu­ment ma­nage­ment sys­tem d.3 life sci­en­ces by d.velop 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 d.velop Life Sci­en­ces, a spe­cia­list from Ge­scher near Müns­ter, which ser­ves around 100 cus­to­mers, the ma­jo­ri­ty of whom are ac­ti­ve in me­di­cal tech­no­lo­gy or in the phar­maceu­ti­cal environment.

d.3 life sciences enables central and digital document management

Aris­to Phar­ma op­ted for the qua­li­ty ma­nage­ment sys­tem (QMS) d.3 life sci­en­ces. 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 d.velop Life Sci­en­ces be­cau­se with d.3 life sci­en­ces 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 d.3 life sci­en­ces, 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 d.3 life sci­en­ces 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. d.3 life sci­en­ces 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 d.3 life sci­en­ces 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 “Em­ployee Qua­li­fi­ca­ti­on 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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