“d.velop Life Sci­en­ces GmbH has sup­por­ted us in the chan­geo­ver to a new elec­tro­nic qua­li­ty ma­nage­ment sys­tem in re­cord time with pro­fes­sio­na­lism and ex­per­ti­se. Six in­de­pen­dent do­cu­ment ma­nage­ment sys­tems were trans­fer­red into one har­mo­ni­zed cen­tral d.3 eQMS. The sup­port in im­ple­men­ting the va­li­da­ti­on re­qui­re­ments for com­pu­ter-ba­sed sys­tems ac­cord­ing to GxP and ISO re­qui­re­ments is ex­cel­lent. The mo­du­les “Do­cu­ment Con­trol”, “Em­ployee Qua­li­fi­ca­ti­on”, „De­via­ti­on Con­trol”, „CAPA” und „Chan­ge Con­trol” are glo­bal­ly ope­ra­ted at SCHOTT AG and by in­te­gra­ting ad­di­tio­nal tools in qua­li­ty ma­nage­ment, the port­fo­lio could be im­pro­ved bey­ond Do­cu­ment Con­trol. We are buil­ding on the po­si­ti­ve ex­pe­ri­en­ces of the coope­ra­ti­on and will con­ti­nue the good part­ners­hip and good coope­ra­ti­on with other topics.”

“As part of the di­gi­ta­liz­a­ti­on pro­cess, Wie­wel­ho­ve has not only di­gi­ta­li­zed the ap­p­li­cant work­flow, but also pro­ces­ses re­la­ted to re­qui­si­tio­ning. 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-term part­ner d.velop Life Sci­en­ces. Once again, the col­leagues were en­thu­si­astic about the so­lu­ti­ons and d.velop Life Sci­en­ces re­peated­ly pro­ved to be a com­pe­tent, hel­pful and open de­ve­lo­p­ment partner.”

“Tog­e­ther with the team of d.velop Life Sci­en­ces, we have im­ple­men­ted our new DMS and trai­ning tool in com­pli­an­ce with GMP in a very short time. Thanks 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. By im­ple­men­ting the DMS and MQM and the com­mit­ment of d.velop, we have mas­te­red a big step towards sys­tem op­ti­miz­a­ti­on. The team of Hen­nig Arz­nei­mit­tel says: “Thank you and we would be glad to do it again!”

“With the pro­ject staff of d.velop Life Sci­en­ces a ra­pid im­ple­men­ta­ti­on of the new DMS was pos­si­ble in only three mon­ths. The mo­du­lar struc­tu­re of the sys­tem ad­di­tio­nal­ly al­lows a coor­di­na­ted step-by-step ex­pan­si­on of the scope. 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 mi­cro­ni­sa­ti­on 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 busi­ness 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 them. Fur­ther­mo­re, we are working with com­pound do­cu­ments. Ano­t­her mi­le­stone will be the EQM mo­du­le. The va­li­da­ti­on of the in­di­vi­du­al mo­du­les is very well struc­tu­red and meets my ex­pec­ta­ti­ons for the va­li­da­ti­on of com­pu­te­ri­sed sys­tems ac­cord­ing to the risk-ba­sed approach.“

“d.velop Life Sci­en­ces has hel­ped us 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.”

“We have been a cus­to­mer from the very be­gin­ning and d.velop Life Sci­en­ces sup­ports us re­li­ab­ly and sus­tainab­ly with their pro­ducts and thus hel­ps us to fur­ther de­ve­lop our QMS and to im­ple­ment elec­tro­nic so­lu­ti­ons / work­flows re­gar­ding the re­qui­re­ments for data integrity.”

“The d.velop Life Sci­en­ces in­stal­led, va­li­da­ted, trai­ned and in­tro­du­ced the eQMS in a re­cord-brea­king time and 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 qua­li­fi­ca­ti­on re­cords 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 the di­gi­tal do­cu­ment ma­nage­ment of d.velop Life Sci­en­ces, which was a quan­tum leap. To­day we can crea­te, find, edit and coor­di­na­te do­cu­ments much fas­ter. This saves working time and costs.“

“A high le­vel of con­sul­ting ex­per­ti­se and the part­ner-like per­for­mance cha­rac­te­ri­ze the suc­cess­ful col­la­bo­ra­ti­on We the­re­fo­re see d.velop Life Sci­en­ces GmbH as a long-term part­ner of our company.”

“In our se­arch for a sui­ta­ble sys­tem, we dis­co­ve­r­ed d.velop Life Sci­en­ces. First of all, the con­trol­led spe­ci­fi­ca­ti­on do­cu­ments from qua­li­ty as­suran­ce, qua­li­ty con­trol and pro­duc­tion were in­te­gra­ted into the Life Sci­ence Sys­tem tog­e­ther. In the pro­cess, we re­cei­ved very good sup­port from d.velop Life Sci­en­ces. Next on the agen­da is the im­ple­men­ta­ti­on of the soft­ware Em­ployee Qua­li­fi­ca­ti­on Ma­nage­ment (EQM). We are to­tal­ly sa­tis­fied with the d.velop Life Sci­en­ces sys­tem and look for­ward to fur­ther cooperation.”

“As an au­to­mo­ti­ve sup­plier, we re­al­ly do have very 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 of d.velop Life Sci­en­ces can do, we did not even look any fur­ther. Ever­ything is now trans­par­ent­ly do­cu­men­ted, ver­sio­ned, ar­chi­ved and traceable.”

“The con­sul­tants of d.velop Life Sci­en­ces were ex­tre­me­ly com­pe­tent and the pro­ject was com­ple­ted wi­t­hin the plan­ned time and cost frame. 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 d.velop 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 EQM for our en­t­i­re group of com­pa­nies with a to­tal of six ger­man lo­ca­ti­ons was glad­ly ac­cep­ted as a gre­at chal­len­ge on the part of d.velop Life Sci­en­ces and was mas­te­red pro­fes­sio­nal­ly and on sche­du­le. The very good pre­pa­ra­ti­on by d.velop 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.”

“The d.velop Life Sci­ence team has been sup­por­ting us for ye­ars to make our pro­ces­ses more ef­fi­ci­ent and di­gi­tal. Over the past few ye­ars, we have thus been able to suc­cess­ful­ly im­ple­ment the GMP com­pli­ant do­cu­ment ma­nage­ment, em­ployee qua­li­fi­ca­ti­on ma­nage­ment and con­tract ma­nage­ment in our com­pa­ny tog­e­ther. 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.”

“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. 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 hig­her qua­li­ty work.”

“We have been working tog­e­ther with d.velop AG very suc­cess­ful­ly and con­ten­ted­ly for ye­ars. Loo­king for a re­li­able part­ner for the tech­ni­cal do­cu­men­ta­ti­on of our me­di­cal pro­ducts, we stumb­led upon the life sci­ence 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.”