GxP-compliant software for your document & quality management

“Di­gi­tal Life Sci­en­ces GmbH sup­port­ed us with pro­fes­sio­na­lism and ex­per­ti­se in re­cord time when we swit­ched to a new elec­tro­nic qua­li­ty ma­nage­ment sys­tem. In the pro­cess, six in­de­pen­dent do­cu­ment ma­nage­ment sys­tems were trans­fer­red to a har­mo­ni­zed cen­tral d.3 eQMS. The sup­port for the im­ple­men­ta­ti­on of va­li­da­ti­on re­qui­re­ments for com­pu­te­ri­zed sys­tems ac­cor­ding to GxP and ISO re­qui­re­ments is ex­cel­lent. The mo­du­les “Do­cu­ment Con­trol”, “Em­ployee Qua­li­fi­ca­ti­on”, “De­via­ti­on Con­trol”, “CAPA” and “Ch­an­ge Con­trol” are in use world­wi­de at SCHOTT AG, and the in­te­gra­ti­on of fur­ther qua­li­ty ma­nage­ment tools has im­pro­ved the port­fo­lio bey­ond do­cu­ment con­trol. We have struck up po­si­ti­ve ex­pe­ri­en­ces from the col­la­bo­ra­ti­on and will con­ti­nue the good part­ner co­ope­ra­ti­on with fur­ther topics.”

“As part of the di­gi­ta­liza­ti­on of­fen­si­ve, Wie­wel­ho­ve has not only di­gi­ta­li­zed the ap­pli­cant work­flow, but also pro­ces­ses re­la­ting to re­qui­si­ti­ons. In the past for in­s­tance, em­ployees nee­ding a new lap­top had to en­ter the pri­ce and other spe­ci­fi­ca­ti­on into a Word file, print the do­cu­ment and for­ward it by in­ter­nal mail. This pro­ce­du­re was not only time-con­sum­ing but also er­ror-pro­ne. We the­r­e­fo­re de­ci­ded to de­ve­lop our own cus­to­mi­zed so­lu­ti­on with our long-stan­ding part­ner Di­gi­tal Life Sci­en­ces. Once again, the col­le­agues were en­thu­si­a­stic about the so­lu­ti­ons and Di­gi­tal Life Sci­en­ces re­pea­ted­ly pro­ved to be a com­pe­tent, hel­pful and open de­ve­lo­p­ment partner.”

“With the Di­gi­tal Life Sci­en­ces team, we im­ple­men­ted our new GMP-com­pli­ant DMS and trai­ning tool in a very short time. Due to the com­pe­tent con­sul­ting, a prag­ma­tic so­lu­ti­on for every pro­blem was quick­ly found and also the drea­ded data mi­gra­ti­on from our old sys­tem was suc­cessful thanks to the da­ta­ba­se spe­cia­lists of d.velop. With the in­tro­duc­tion of DMS and Trai­ning Ma­nage­ment and the com­mit­ment of d.velop, we have ta­ken a big step towards sys­tem op­ti­miza­ti­on. The en­ter­pri­se team of Hen­nig Arz­nei­mit­tel says Thank you and we’d be plea­sed to do it again!”

“With the pro­ject team from Di­gi­tal Life Sci­en­ces, it was pos­si­ble to im­ple­ment the new DMS quick­ly in just th­ree months. The mo­du­lar struc­tu­re of the sys­tem ad­di­tio­nal­ly al­lows a coor­di­na­ted step-by-step ran­ge ex­ten­si­on. The soft­ware was quick­ly ac­cept­ed by all em­ployees due to its clear de­sign, which not only sim­pli­fied the pro­ces­ses and re­lease cy­cles in a very short time, but also im­pro­ved their quality.”

“As a ser­vice pro­vi­der for the mi­cro­niza­ti­on of phar­maceu­ti­cal raw ma­te­ri­als, we at GfM have to meet the qua­li­ty re­qui­re­ments of our cus­to­mers. The in­tro­duc­tion of d.3 with its mo­du­lar struc­tu­re is the­r­e­fo­re very well sui­ted for us to di­gi­tal­ly map our com­pa­ny pro­ces­ses step by step and at the same time com­ply with the re­gu­la­ti­ons. We curr­ent­ly ma­na­ge a wide va­rie­ty of do­cu­ment ty­pes in the sys­tem and are gra­du­al­ly ex­pan­ding this fur­ther. We also work with com­pound do­cu­ment. An­o­ther mi­le­stone will be the trai­ning ma­nage­ment mo­du­le. The va­li­da­ti­on of the in­di­vi­du­al mo­du­les is very well struc­tu­red and meets my ex­pec­ta­ti­ons for the va­li­da­ti­on of com­pu­te­ri­zed sys­tems ac­cor­ding to the risk-ba­sed approach.”

“Di­gi­tal Life Sci­en­ces has hel­ped us to make our pa­per-ba­sed pro­ces­ses more di­gi­tal. In the past, we main­ly prin­ted out a lot of things, stam­ped them, si­gned them and tran­sac­ted them on pa­per or with of­fice do­cu­ments. Some things had to be kept in hard­co­py form for ye­ars. To­day, we work with real di­gi­tal do­cu­ments that we can dis­tri­bu­te with just a few clicks, re­gard­less of whe­ther the em­ployees in ques­ti­on are curr­ent­ly working at home or so­me­whe­re else. Pro­ces­ses have be­co­me at least 20 per­cent faster.”

“Up­dating do­cu­ments, re­prin­ting, re­sig­ning, and in­va­li­da­ting the old do­cu­ments: The flood of pa­per­work had com­ple­te­ly over­whel­med us af­ter 25 ye­ars of com­pa­ny histo­ry. We had seen the need to get rid of pa­per whe­re we could. With the Do­cu­ment Con­trol by Di­gi­tal Life Sci­en­ces GmbH, we cer­tain­ly save 30 to 40 per­cent of working time in the do­cu­men­ta­ti­on. For ex­am­p­le, it has be­co­me much ea­sier to cor­rect do­cu­ments. Work has be­co­me more ef­fi­ci­ent over­all. Ever­y­thing is much fas­ter and less cum­ber­so­me. Di­gi­tal Life Sci­en­ces is not just a ser­vice pro­vi­der, they work re­al­ly gre­at with us.”

“We have been a cus­to­mer from the very be­gin­ning and Di­gi­tal Life Sci­en­ces sup­ports us re­lia­bly and sus­tain­ab­ly with its pro­ducts, hel­ping us to fur­ther de­ve­lop our QMS and map elec­tro­nic so­lu­ti­ons / work­flows while ta­king data in­te­gri­ty re­qui­re­ments into account.”

“Di­gi­tal Life Sci­en­ces work­ed with us to in­stall, va­li­da­te, train and in­tro­du­ce the eQMS in re­cord time in a high­ly pro­fes­sio­nal man­ner. A re­al­ly strong per­for­mance. The soft­ware is gre­at and helps us to si­gni­fi­cant­ly op­ti­mi­ze our pro­ces­ses and make them more efficient.”

“Ye­ars ago, we used to track the sta­tus of do­cu­ments such as work in­s­truc­tions, em­ployee’s pro­ofs of qua­li­fi­ca­ti­on, and batch re­ports using an Ac­cess da­ta­ba­se or on pa­per. Ho­we­ver, it was te­dious to keep the do­cu­ments up to date and to ma­na­ge them in an au­dit-com­pli­ant man­ner. in 2012, we swit­ched to di­gi­tal do­cu­ment con­trol for Di­gi­tal Life Sci­en­ces, which was a quan­tum leap. To­day we can crea­te, find, edit and agree upon do­cu­ments much fas­ter. This sa­ves working time and costs.”

“Pri­or to 2016, we did have an elec­tro­nic do­cu­ment rou­ting sys­tem in place, but it was all not as clean and per­for­mant as it should have been. For ex­am­p­le, we missed a good over­view of which em­ployee is trai­ned to what ext­ent. Tha­t’s what we have to­day thanks to Di­gi­tal Life Sci­en­ces. This is im­portant, for ex­am­p­le, for an ex­ter­nal au­dit. With the old sys­tem, we still had to do many things ma­nu­al­ly. With Di­gi­tal Life Sci­en­ces’ eQMS so­lu­ti­on, qua­li­ty and speed have ta­ken a leap upward.”

“The suc­cessful col­la­bo­ra­ti­on is cha­rac­te­ri­zed by a high le­vel of con­sul­ting ex­per­ti­se and a part­ner­ship-ba­sed ap­proach, which is why we see Di­gi­tal Life Sci­en­ces GmbH as a long-term part­ner for our company.”

“In our search for a sui­ta­ble sys­tem, we be­ca­me awa­re of Di­gi­tal Life Sci­en­ces. First, the con­trol­led spe­ci­fi­ca­ti­on do­cu­ments from qua­li­ty assu­rance, qua­li­ty con­trol and pro­duc­tion were joint­ly in­te­gra­ted into the life sci­ence sys­tem. We re­cei­ved very good sup­port from Di­gi­tal Life Sci­en­ces th­roug­hout. The soft­ware trai­ning ma­nage­ment is curr­ent­ly be­ing im­ple­men­ted and the ch­an­ge con­trol mo­du­le will be ad­ded next year. We are com­ple­te­ly sa­tis­fied with the Di­gi­tal Life Sci­en­ces sys­tem and look for­ward to con­ti­nuing our collaboration.”

“As an au­to­mo­ti­ve sup­pli­er, we have re­al­ly ex­ten­si­ve do­cu­men­ta­ti­on ob­li­ga­ti­ons in qua­li­ty ma­nage­ment. In the past, such an amen­ded re­gu­la­ti­on took a good week to cir­cu­la­te. We have loo­ked at many so­lu­ti­ons to op­ti­mi­ze pro­ces­ses. But when we saw what the di­gi­ta­liza­ti­on so­lu­ti­ons from Di­gi­tal Life Sci­en­ces can do, we loo­ked no fur­ther. Ever­y­thing is now trans­par­ent­ly do­cu­men­ted, ver­sio­ned, ar­chi­ved and traceable.”

“The Di­gi­tal Life Sci­en­ces con­sul­tants were ex­tre­me­ly com­pe­tent and the pro­ject was com­ple­ted on time and wi­thin bud­get. What else could you ex­pect? The co­ope­ra­ti­on du­ring the de­ve­lo­p­ment of our QM mo­du­le was very good th­roug­hout and fi­nal­ly led to the in­tro­duc­tion of the new Tech­ni­cal Do­cu­men­ta­ti­on mo­du­le at the DMG”

“Al­re­a­dy du­ring the first pre­sen­ta­ti­on of the pro­duct in our com­pa­ny, one could feel the bund­led pro­fes­sio­nal com­pe­tence and the eye for a user-fri­end­ly so­lu­ti­on at Di­gi­tal Life Sci­en­ces GmbH. As part of the pro­ject im­ple­men­ta­ti­on, user re­qui­re­ments were im­ple­men­ted quick­ly and to the full sa­tis­fac­tion of the users. We can re­com­mend the so­lu­ti­on with a clear conscience.”

“The in­tro­duc­tion of a DMS in­clu­ding the GMP mo­du­les con­trol­led do­cu­ments and Trai­ning Ma­nage­ment for our en­ti­re group of com­pa­nies at the six Ger­man sites was ac­cept­ed as a ma­jor chall­enge by Di­gi­tal Life Sci­en­ces and mas­te­red pro­fes­sio­nal­ly and on time. The very good pre­pa­ra­ti­on by Di­gi­tal 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 in or­der to suc­cessful­ly in­crease our ef­fi­ci­en­cy even further.”

“The Di­gi­tal Life Sci­en­ces team has been sup­port­ing us for ye­ars in ma­king our pro­ces­ses more ef­fi­ci­ent and di­gi­tal. In re­cent ye­ars, we have suc­cessful­ly im­ple­men­ted the DMS, trai­ning ma­nage­ment and con­tract ma­nage­ment in our com­pa­ny in com­pli­ance with GMP. We are hap­py to build on our po­si­ti­ve ex­pe­ri­ence with the Di­gi­tal Life Sci­en­ces team and curr­ent­ly have num­e­rous pro­jects in the pipe­line that will make our do­cu­men­ta­ti­on more di­gi­tal, traceable and cen­tra­li­zed. Di­gi­tal Life Sci­en­ces GmbH is a strong and long-term part­ner for us.”

“With its dls | eQMS, Di­gi­tal Life Sci­en­ces GmbH is hel­ping us to stra­te­gi­cal­ly de­ve­lop our QMS and map elec­tro­nic so­lu­ti­ons / work­flows in line with GMP and ISO re­qui­re­ments. Curr­ent­ly, the mo­du­les “Do­cu­ment Con­trol”, “Trai­ning Ma­nage­ment”, “De­via­ti­on Con­trol” and “CAPA” have been im­ple­men­ted and the ERP sys­tem has been in­te­gra­ted on the in­ter­face side in or­der to be able to use the exis­ting pro­cess in­for­ma­ti­on across sys­tems. We are al­re­a­dy loo­king for­ward to many ex­ci­ting fu­ture pro­jects thanks to the wide ran­ge of pos­si­bi­li­ties and the con­stant ex­pan­si­on of func­tions in dls | eQMS. Whe­ther for the in­tro­duc­tion of fur­ther do­cu­ment ty­pes or new mo­du­les, in or­der to be able to suc­cessful­ly fur­ther in­crease our ef­fi­ci­en­cy and make our do­cu­men­ta­ti­on more di­gi­tal, traceable and centralized.”

“Many do­cu­ments, tem­pla­tes or files found them­sel­ves in our Win­dows fol­der sys­tem. This was not the ide­al case. We wan­ted that to be bet­ter, more ac­ces­si­ble, safer and fas­ter. Whe­re we used to have to brow­se th­rough fol­ders, we’­re now much fas­ter. We now have more time for hig­her qua­li­ty work. We used to have a lot of fol­ders and nee­ded a lot of head work. Now it’s a hig­her qua­li­ty of work.”

“We have been working tog­e­ther with d.velop AG very suc­cessful­ly and sa­tis­fac­to­ri­ly for ye­ars. Loo­king for a re­lia­ble part­ner for the tech­ni­cal do­cu­men­ta­ti­on of our me­di­cal pro­ducts, we stumb­led upon the Life Sci­en­ces Cli­ent. With the tran­si­ti­on to the new struc­tu­re of EU MDR, we were able to ful­ly ex­ploit the po­ten­ti­al of the Life Sci­en­ces Cli­ent for us and thus fa­ci­li­ta­te the work of do­cu­ment crea­ti­on and im­pro­ve ac­cep­tance in the company.”