Change management (Change Control) for more data integrity and traceability

d.velop Life Sci­en­ces GmbH has al­rea­dy been suc­cess­ful as a part­ner of d.velop AG sin­ce 2007. The ma­na­ging di­rec­tors and long-time em­ployees are among the co-in­ven­tors of d.3: The d.3ecm ba­sic pro­duct is me­an­while used by more than 10,000 cus­to­mers as ECM/DMS/archive system.

The so­lu­ti­ons of d.velop Life Sci­en­ces GmbH are to be un­ders­tood as a com­ple­men­ta­ry ad­di­ti­ons to the ba­sic pro­duct d.3. We of­fer you va­li­da­t­a­ble so­lu­ti­ons in the sec­tors Do­cu­ment Con­trol, Trai­ning Ma­nage­ment, De­via­ti­on Ma­nage­ment, CAPA, Chan­ge Con­trol or Chan­ge Ma­nage­ment, Com­p­laints, Pro­cess Do­cu­men­ta­ti­on, Con­tract Ma­nage­ment and Di­gi­tal Per­son­nel File. Learn more about our pro­fes­sio­nal chan­ge ma­nage­ment and our other soft­ware solutions.

Our soft­ware so­lu­ti­ons can be ex­ten­ded like mo­du­lar buil­ding blocks to a com­ple­te GxP-com­pli­ant eQMS suite. They pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses of manufacturing/production and the qua­li­ty ma­nage­ment. In ad­di­ti­on to our cus­to­mers of the clas­si­cal Life Sci­en­ces in­dus­try (phar­maceu­ti­cal, me­di­cal tech­no­lo­gy, food sup­ple­ments, cos­me­tics), also cus­to­mers from the steel in­dus­try and the ser­vice sec­tor trust our solutions.

Learn more about our Chan­ge Con­trol soft­ware solution.

What are the focal points of our software solutions

With our so­lu­ti­on suite d.3 life sci­en­ces, you can ar­chi­ve any do­cu­ments such as in­voices, ma­nu­fac­tu­ring re­cords, de­li­very no­tes, quo­ta­ti­ons and much more – ever­ything is stored in the di­gi­tal cen­tral ar­chi­ve in com­pli­an­ce with the re­gu­la­to­ry re­qui­re­ments (GxP or GoBD). Fur­ther­mo­re, we have spe­ci­fi­cal­ly ex­pan­ded our ar­chi­ve sys­tem with re­gard to elec­tro­nic si­gna­tu­re so­lu­ti­ons for GxP re­qui­re­ments. Thus, you can e.g. re­lease your batch do­cu­men­ta­ti­on and keep your batch re­cord elec­tro­ni­cal­ly. Keep a di­gi­tal over­view of chan­ge re­quests and the like and save on un­ne­cessa­ry paper.

Change Control — our Change Management in detail

With our chan­ge ma­nage­ment (Chan­ge Con­trol) you con­trol your QM pro­cess with our elec­tro­nic work­flows. The chan­ge is clas­si­fied ac­cord­ing to the meta data en­t­e­red in the form. In ad­di­ti­on, an au­to­ma­ti­cal­ly ge­ne­ra­ted PDF ba­sed on the form is stored in the sys­tem af­ter each step. Of cour­se we have also ad­ded our elec­tro­nic si­gna­tu­re to our QM workflows.

What benefits do you get from Change Control (CC)?

By using the Chan­ge Con­trol (CC) by d.velop Life Sci­en­ces, you can si­gni­fi­cant­ly re­du­ce your cos­ts and pro­ces­sing times and in­cre­a­se the qua­li­ty of your results.

Fur­ther­mo­re, you can make chan­ges to pro­ducts, pro­ces­ses or sys­tems against the back­ground of re­gu­la­to­ry and in­ter­nal specifications.

Chan­ge ma­nage­ment can be lin­ked to upstream pro­ces­ses, such as de­via­ti­on re­ports or cor­rec­ti­ve and pre­ven­ti­ve ac­tions. This fa­ci­li­ta­tes the in­ter­ac­tion of the in­di­vi­du­al ma­nage­ment steps and hel­ps the chan­ge process.

In terms of pro­cess re­lia­bi­li­ty, the work­flow sys­tem en­su­res that af­ter each pro­cess step, the task is as­si­gned to the next per­son in char­ge. An es­ca­la­ti­on sys­tem ta­kes ef­fect in the event of timeouts.

Fi­nal­ly, every em­ployee is en­ti­t­led to view the cur­rent sta­tus of all Chan­ge Con­trol pro­ces­ses, even if the­re is no pro­cess par­ti­ci­pa­ti­on. In terms of con­trol­ling, it is ul­ti­mate­ly pos­si­ble to crea­te re­ports and sta­tis­tics of the CCs.

The team of d.velop Life Sciences GmbH — professional, competent and helpful

If you have any fur­ther ques­ti­ons or re­qui­re in­for­ma­ti­on about our other soft­ware so­lu­ti­ons or the Chan­ge Con­trol, the team at d.velop Life Sci­en­ces GmbH will be hap­py to help you. Plea­se feel free to con­ta­ct us at any time. We will pro­vi­de you with com­pre­hen­si­ve consultancy.

Are you looking for a solution for your change processes?

Then take a look at our so­lu­ti­on now