Digitize your ISO processes with electronic deviation management / Deviation Control

The so­lu­ti­on: De­via­ti­on Control
The so­lu­ti­on: De­via­ti­on Control

If you in­tend to di­gi­ti­ze your pa­per-bound ISO pro­ces­ses, Di­gi­tal Life Sci­en­ces GmbH will be glad to as­sist you with its ex­pe­ri­ence and soft­ware so­lu­ti­ons. Whe­ther De­via­ti­on Con­trol (DC) Ch­an­ge Ma­nage­ment (CC) or Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tions (CAPA) — with our soft­ware so­lu­ti­ons, you can di­gi­tal­ly im­ple­ment your pro­ces­ses from cap­tu­re to com­ple­ti­on. Learn more about our pro­fes­sio­nal de­via­ti­on con­trol software.

We are your part­ner for GxP-com­pli­ant do­cu­men­ta­ti­on so­lu­ti­ons — Di­gi­tal Life Sci­en­ces GmbH de­ve­lo­ps and mar­kets soft­ware for the seam­less di­gi­tiza­ti­on of busi­ness pro­ces­ses and in­dus­try-spe­ci­fic spe­cia­li­zed pro­ce­du­res. Our fo­cus is on the con­trol and ar­chi­ving of re­cords, the con­trol of do­cu­ments and pro­duc­tion-re­la­ted QM processes.

Dis­co­ver our ser­vice port­fo­lio and our com­pe­tent cus­to­mer ser­vice for yours­elf. If you have any ques­ti­ons, we’d be plea­sed to give a de­tail­ed consultation.

Deviation Control ensures transparency & process reliability

Con­duct your pre­vious­ly pa­per-ba­sed pro­cess elec­tro­ni­cal­ly and take ad­van­ta­ge of the num­e­rous be­ne­fits in De­via­ti­on Con­trol with our de­via­ti­on ma­nage­ment software.

De­via­ti­on re­ports are stored elec­tro­ni­cal­ly from the out­set and can be lin­ked to other mo­du­les such as Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tions (CAPA) and Ch­an­ge Ma­nage­ment (CC). This makes it easy to trace in­ter­re­la­ted in­di­vi­du­al pro­ces­ses. Fur­ther­mo­re, our so­lu­ti­ons for De­via­ti­on Con­trol al­low si­gni­fi­cant­ly lower pro­cess runtimes.

Af­ter each step, the work­flow sys­tem en­su­res that de­via­ti­on re­ports are for­ward­ed to the re­spec­ti­ve per­son in char­ge. The es­cala­ti­on sys­tem ta­kes ef­fect in case of missed dead­lines. This sim­pli­fies your qua­li­ty assurance.

De­via­ti­on Con­trol also me­ans that every aut­ho­ri­zed em­ployee can see the cur­rent sta­tus of all de­via­ti­on re­ports — even if he or she is not in­vol­ved in the pro­cess. This en­su­res a high le­vel of trans­pa­ren­cy. Mo­reo­ver, re­ports and sta­tis­tics can be ge­ne­ra­ted on your de­via­ti­on re­ports, e.g. as sup­port for your PQR.

Deviation Control offers numerous advantages

Our di­gi­tal de­via­ti­on ma­nage­ment so­lu­ti­ons enable au­to­ma­tic PDF crea­ti­on and sto­rage of the form in the eDMS af­ter each step and au­to­ma­tic clas­si­fi­ca­ti­on of the de­via­ti­on ba­sed on the me­ta­da­ta en­te­red in the form. Mo­reo­ver, the mas­ter data can be re­fe­ren­ced from the ERP sys­tem and do­cu­ments can be added.

In­di­vi­du­al tasks can be as­si­gned for fur­ther pro­ces­sing and es­cala­ti­on mes­sa­ges can be sent both wi­thin the sys­tem and by e‑mail.

Re­gu­la­to­ry re­qui­re­ments are for example:

QM processes accompanying production

With our elec­tro­nic work­flows, you can ea­si­ly con­trol pro­ces­ses such as de­via­ti­on ma­nage­ment (De­via­ti­on Con­trol), Cor­rec­ti­ve And Pre­ven­ti­ve Ac­tions (CAPA) and ch­an­ge ma­nage­ment (Ch­an­ge Con­trol). Be­ne­fit from ef­fec­ti­ve sup­port in crea­ting re­ports and ge­ne­ra­te sta­tis­tics on the fre­quen­cy, cri­ti­cal­i­ty or run­time of your QM pro­ces­ses. In or­der to in­crease trans­pa­ren­cy and abili­ty to pro­vi­de in­for­ma­ti­on in your com­pa­ny, aut­ho­ri­zed em­ployees also have ac­cess to the run­ning pro­ces­ses that are not in­vol­ved in the process.

We offer you solutions developed against the regulatory background

Be it Do­cu­ment Con­trol, Trai­ning Ma­nage­ment, De­via­ti­on Ma­nage­ment (De­via­ti­on Con­trol) Ch­an­ge ma­nage­ment (CC) or Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tion (CAPA) or Con­tract Ma­nage­ment – we of­fer di­gi­tiza­ti­on so­lu­ti­ons de­ve­lo­ped spe­ci­fi­cal­ly for the re­gu­la­to­ry back­ground. Sim­ply tell us your re­qui­re­ments and needs — we will be hap­py to ad­apt our so­lu­ti­ons to the life­cy­cle of your spe­ci­fi­ca­ti­on do­cu­ments and forms.

Thou­sands of cus­to­mers suc­cessful­ly use our ba­sic pro­duct d.3 as their cen­tral ECM/DMS/archive sys­tem, many of them in the phar­maceu­ti­cal in­dus­try. The so­lu­ti­ons of­fe­red by us are com­ple­men­ta­ry sup­ple­ments to the ba­sic sys­tem d.3 and ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring / pro­duc­tion and qua­li­ty ma­nage­ment.

If you have any ques­ti­ons about our ran­ge of ser­vices, we will gl­ad­ly ans­wer them and ad­vi­se you in de­tail about your op­ti­ons. Just cont­act us — we look for­ward to your in­quiry and will help you in a com­pe­tent and fri­end­ly manner.

Are you looking for a solution for your deviation processes?

Then take a look at our so­lu­ti­on now

The so­lu­ti­on: De­via­ti­on Control
Illustration of a notebook on which the QM-workflows of Digital Life Sciences are mapped, Complaint, Deviation Control, CAPA, Change Control