QM system

d.velop Life Sciences focuses on quality and the ISO 9001

TÜVRheinland Signet Management System ISO 9001:2015 with the ID of d.velop Life Sciences

We are TÜV Rhein­land tes­ted and cer­ti­fied ac­cord­ing to ISO 9001–2015.

This gua­ran­tees you that we meet the re­qui­re­ments of ISO 9001 in our qua­li­ty ma­nage­ment sys­tem and that we con­sist­ent­ly meet the qua­li­ty de­man­ds of our processes.

DIN EN ISO 9001:2015 is the most wi­despread and most im­portant na­tio­nal and in­ter­na­tio­nal stan­dard in qua­li­ty ma­nage­ment. As the ba­sis for the con­ti­nuous im­pro­ve­ment pro­cess, it ser­ves pri­ma­ri­ly to meet cus­to­mer re­qui­re­ments and to en­dea­vour to meet cus­to­mer expectations.

The cer­ti­fi­ca­ti­on con­sists of the de­mons­tra­ti­on of the prac­ti­cal ap­p­li­ca­ti­on as well as a re­view of the do­cu­men­ta­ti­on. With the suc­cess­ful cer­ti­fi­ca­ti­on, we de­mons­tra­te that we have mas­te­red the high qua­li­ty de­man­ds of our cus­to­mers in the long term and that qua­li­ty ori­en­ta­ti­on in every sub-pro­cess de­ter­mi­nes our thin­king and ac­tions. Qua­li­ty ma­nage­ment is the dri­ving for­ce for the con­ti­nuous in­cre­a­se in performance.

Our QM system

Our QM sys­tem con­sists, as most com­pa­nies do, of soft­ware, hard­ware, pro­ces­ses, do­cu­ments, re­cords and peop­le. As QM soft­ware we use the same pro­ducts which we sell to our cus­to­mers. We are thus our own cus­to­mer. In ad­di­ti­on to Do­cu­ment Con­trol and Em­ployee Qua­li­fi­ca­ti­on we use the Chan­ge Con­trol work­flow for in­ci­dents re­le­vant to busi­ness processes.

Audits

Our pro­ducts were laun­ched and va­li­da­ted suc­cess­ful­ly in nu­me­rous phar­maceu­ti­cal com­pa­nies. Du­ring TÜV au­dits and in­spec­tions of the re­gio­nal coun­cil (Ger­ma­ny) our pro­ducts were also au­di­ted suc­cess­ful­ly ac­cord­ing to ISO stan­dards 9001 and 13485.

We are a soft­ware sup­plier for com­pa­nies from the GxP en­vi­ron­ment. In this en­vi­ron­ment the im­ple­men­ta­ti­on of sup­plier au­dits is com­mon prac­ti­ce. In the last ye­ars we have been au­di­ted many times in on-site au­dits and pos­tal au­dits by our cus­to­mers and pro­spec­ti­ve customers.

Illustration of the addressed regulations, which d.velop Life Sciences takes into account with its software solutions.

Regulations addressed

Our soft­ware so­lu­ti­ons take into ac­count the re­le­vant laws, gui­de­li­nes and stan­dards in the re­gu­la­ted en­vi­ron­ment and have been de­ve­lo­ped spe­ci­fi­cal­ly with this in mind. Our pro­ducts have also been in­tro­du­ced and suc­cess­ful­ly va­li­da­ted at nu­me­rous com­pa­nies in the life sci­en­ces industry.

Document Control

In our com­pa­ny we use dif­fe­rent do­cu­ment cir­cu­la­ti­ons. In ad­di­ti­on to the clas­si­cal work and pro­cess in­st­ruc­tions, also soft­ware spe­ci­fi­ca­ti­ons and qua­li­ty as­suran­ce do­cu­ments are ma­na­ged, re­view­ed, ap­pro­ved and released.

All do­cu­ments in our com­pa­ny are trai­ned elec­tro­ni­cal­ly. For this pur­po­se, we have de­si­gna­ted trai­ning coor­di­na­tors who are gi­ven the task of de­ter­mi­ning the trai­ning re­le­van­ce for their field of re­spon­si­bi­li­ty when new do­cu­ments (first ver­si­ons) are crea­ted. For fol­low-up ver­si­ons, the sys­tem can thus de­li­ver the re­le­vant do­cu­ments automatically.

Illustration of a face-to-face training with countless participants

Face-to-face trainings

We also plan our face-to-face trai­nings with the soft­ware de­ve­lo­ped by us. We pri­ma­ri­ly train pro­ce­du­res and pro­ces­ses, which as part of our on­boar­ding pro­cess, must be taught to the new em­ployees. Data pro­tec­tion is ano­t­her sub­ject that we teach in face-to-face trai­nings. Alt­hough in the em­ploy­ment con­tracts, con­fi­den­tia­li­ty and data pro­tec­tion de­cla­ra­ti­ons are si­gned, we con­si­der it ne­cessa­ry that our em­ployees are espe­cial­ly sen­si­ti­zed for this to­pic. In or­der to pro­of that trai­nings have been per­for­med, we store the si­gned trai­ning she­ets in the per­son­nel files of our employees.

Process documentation

As a soft­ware and ser­vice com­pa­ny, we are TÜV Rhein­land tes­ted and cer­ti­fied ac­cord­ing to ISO 9001:2015. As an in­for­ma­ti­on sys­tem for our em­ployees, we do­cu­ment our busi­ness pro­ces­ses with the soft­ware we have de­ve­lo­ped for this pur­po­se. In many com­pa­nies this is a very com­plex task and all be­gin­nings are dif­fi­cult. The­re­fo­re, we have op­ted for a top-down ap­proach and we have star­ted with our main pro­ces­ses in the three fiel­ds ma­nage­ment pro­ces­ses, core pro­ces­ses and sup­port pro­ces­ses. The­se are con­ti­nuous­ly do­cu­men­ted more gra­nu­lar­ly by in­clu­ding the cor­re­spon­ding sub-pro­ces­ses. All busi­ness pro­ces­ses we di­rect­ly link with re­le­vant work in­st­ruc­tions and pro­cess in­st­ruc­tions of our eQMS, but also with check lists, forms, white pa­pers and en­coded pass­word lists of our eDMS.

Illustration of a digital process documentation
Illustration of a product development process in the form of codes

Product development process

The pro­duct de­ve­lo­p­ment pro­cess with re­spect to re­gu­la­to­ry re­qui­re­ments de­man­ds a very high le­vel of qua­li­ty. In all are­as of pro­duct de­ve­lo­p­ment (de­ve­lo­p­ment, do­cu­men­ta­ti­on, qua­li­ty as­suran­ce, pro­duct ma­nage­ment), our QM sys­tem de­li­vers the re­qui­red work and pro­cess in­st­ruc­tions. But also test de­sign spe­ci­fi­ca­ti­ons, test re­ports, test plans, soft­ware spe­ci­fi­ca­ti­ons, test im­ple­men­ta­ti­on re­ports, re­qui­re­ment do­cu­ments and also tech­ni­cal and pro­fes­sio­nal spe­ci­fi­ca­ti­ons are ma­na­ged with our QM sys­tem and must pass a si­gna­tu­re work­flow which in­clu­des a con­tent-re­la­ted re­view and ap­pro­val as well as a for­mal re­lease and au­to­ma­tic implementation.

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Solution overview d.velop Life Sciences