Digital solutions for training management including qualification matrix

d.velop Life Sci­en­ces GmbH of­fers GxP-com­pli­ant do­cu­men­ta­ti­on so­lu­ti­ons, which pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses of ma­nu­fac­tu­ring / pro­duc­tion and qua­li­ty ma­nage­ment. From do­cu­ment con­trol and de­via­ti­on ma­nage­ment (DC), CAPA, pro­cess do­cu­men­ta­ti­on, di­gi­tal per­son­nel file and trai­ning ma­nage­ment in­clu­ding qua­li­fi­ca­ti­on ma­trix to chan­ge ma­nage­ment (CC), batch do­cu­men­ta­ti­on and con­tract ma­nage­ment, we of­fer our cus­to­mers in­di­vi­du­al so­lu­ti­ons ac­cord­ing to their wis­hes and needs.

We de­ve­lop and mar­ket soft­ware for the end-to-end di­gi­tiz­a­ti­on of busi­ness pro­ces­ses and in­dus­try-spe­ci­fic spe­cia­li­zed procedures.

Our fo­cus is on the con­trol of re­cords and ar­chi­ving, the con­trol of do­cu­ments as well as pro­duc­tion-re­la­ted QM pro­ces­ses. Our pro­ducts have al­rea­dy been in­tro­du­ced and suc­cess­ful­ly va­li­da­ted at nu­me­rous com­pa­nies. Our di­gi­tiz­a­ti­on so­lu­ti­ons have also been suc­cess­ful­ly au­di­ted by TÜV in ac­cordance with the gui­de­li­nes of the ISO stan­dards 9001 and 13485 as well as du­ring in­spec­tions of the re­gio­nal coun­cil (Ger­ma­ny). We are plea­sed to have a cus­to­mer base of over 70 cus­to­mers. The ma­jo­ri­ty of our cus­to­mers are pro­jects from the life sci­en­ces sec­tor that re­qui­re va­li­da­ti­on.

Learn more about our soft­ware so­lu­ti­on for your trai­ning ma­nage­ment.

Training management — digital planning & documentation of the qualification level of your employees

Do you still keep ma­nu­al EXCEL lists to map the qua­li­fi­ca­ti­on ma­trix? That does­n’t have to be. With our trai­ning ma­nage­ment so­lu­ti­on you can di­gi­tal­ly plan and do­cu­ment the qua­li­fi­ca­ti­on le­vel of your em­ployees. Do­cu­ment-ba­sed trai­nings are sup­por­ted as well as ex­ter­nal trai­nings or fur­ther edu­ca­ti­on. The con­sis­tent in­te­gra­ti­on of the trai­ning mo­du­le into the “Con­trol­led Do­cu­ments” mo­du­le also com­ple­tes your di­gi­tiz­a­ti­on strategy.

Our so­lu­ti­on is de­si­gned to sup­port in the sen­se that only em­ployees who have been suc­cess­ful­ly trai­ned are aut­ho­ri­zed to car­ry out the cor­re­spon­ding ac­ti­vi­ties. In ad­di­ti­on, an ana­ly­sis of the trai­ning sta­tus ba­sed on a do­cu­ment, an em­ployee or a qua­li­fi­ca­ti­on pro­fi­le is con­ve­ni­en­t­ly pos­si­ble. Plan your trai­ning mea­su­res digitally.

When­u­sed in com­bi­na­ti­on with our “Con­trol­led Do­cu­ments” mo­du­le, the re­lease of a new do­cu­ment re­vi­si­on au­to­ma­ti­cal­ly ge­ne­ra­tes the as­so­cia­ted trai­ning tasks.

Our di­gi­tal trai­ning ma­nage­ment so­lu­ti­on pro­vi­des sup­port for do­cu­ment trai­nings, face-to-face trai­nings and ex­ter­nal trai­nings. Fur­ther­mo­re, an op­tio­nal lear­ning suc­cess con­trol ba­sed on mul­ti­ple choice tests is pos­si­ble. Con­fi­gura­ble re­peat in­ter­vals, au­to­ma­tic ge­nera­ti­on of trai­ning she­ets and par­ti­ci­pant lists as well as au­to­ma­tic de­li­very of re­le­vant do­cu­ments when chan­ging de­part­ments can also be set.

Main­tain con­trol and over­view of em­ployee trai­ning, re­qui­re­ments, and qua­li­fi­ca­ti­ons of your em­ployees. All this is au­to­ma­ted and di­gi­tal­ly do­cu­men­ted by our trai­ning ma­nage­ment soft­ware solution.

Regulatory requirements:

  • ISO 9001:2015, chap­ter 7
  • ISO 13485:2016, chap­ter 6
  • EU-GMP Gui­de­li­ne part 1, chap­ter 2
  • EU-GMP Gui­de­li­ne part 2, chap­ter 3
  • Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­ci­nal Pro­ducts and ac­ti­ve Phar­maceu­ti­cal In­gre­dients sec­tion 2, §4
  • FDA 21 CFR 211 Sub­part B

Comprehensive solutions for all aspects of electronic documentation

With do­cu­ment con­trol , trai­ning ma­nage­mentde­via­ti­on ma­nage­ment (DC)chan­ge ma­nage­ment (CC) and cor­rec­ti­ve and pre­ven­ti­ve ac­tion (CAPA) as well as con­tract ma­nage­ment and pro­cess do­cu­men­ta­ti­on, we of­fer you com­pre­hen­si­ve di­gi­tiz­a­ti­on so­lu­ti­ons ac­cord­ing to your in­di­vi­du­al wis­hes and needs. Our so­lu­ti­ons are spe­cia­li­zed on the life cy­cle of its spe­ci­fi­ca­ti­ons and form sheets.

Our ba­sic pro­duct d.3 is me­an­while used by more than 8,500 cus­to­mers world­wi­de as a cen­tral ECM/DMS/archive sys­tem. Our so­lu­ti­ons are a com­ple­men­ta­ry sup­ple­ment to d.3 and are pri­ma­ri­ly de­si­gned for do­cu­ment-ba­sed pro­ces­ses of ma­nu­fac­tu­re / pro­duc­tion and qua­li­ty management.

Our com­pa­ny buil­ding is lo­ca­ted on the cam­pus of d.velop AG in Ge­scher — we will glad­ly be at your dis­po­sal for a de­tail­ed con­sul­ta­ti­on. You can re­ach us by pho­ne un­der +49 (0) 2542 — 20201 0 or via our con­ta­ct form.

We are loo­king for­ward to your inquiry.

Are you looking for a solution for your training measures?

Then take a look at our so­lu­ti­on now