Representation of the logo of ChemCon GmbH

ChemCon saves up to 40 percent of working time in certain sections with digital Document Control

“Up­dating do­cu­ments, re­prin­ting, re­sig­ning, and in­va­li­da­ting the old do­cu­ments: The flood of pa­per­work had com­ple­te­ly over­whel­med us af­ter 25 ye­ars of com­pa­ny histo­ry. We had seen the need to get rid of pa­per whe­re we could. With the Do­cu­ment Con­trol by Di­gi­tal Life Sci­en­ces GmbH, we cer­tain­ly save 30 to 40 per­cent of working time in the do­cu­men­ta­ti­on. For ex­am­p­le, it has be­co­me much ea­sier to cor­rect do­cu­ments. Work has be­co­me more ef­fi­ci­ent over­all. Ever­y­thing is much fas­ter and less cum­ber­so­me. Di­gi­tal Life Sci­en­ces is not just a ser­vice pro­vi­der, they work re­al­ly gre­at with us.”

Ilka Noack, Vice Director of Quality Assurance and Regulatory Affairs bei ChemCon GmbH
Ilka Noack
Vice Di­rec­tor of Qua­li­ty Assu­rance and Re­gu­la­to­ry Af­fairs (Chem­Con GmbH)

Ac­ti­ve phar­maceu­ti­cal in­gre­di­ents for com­ba­ting rare di­se­a­ses, for emer­gen­cy me­di­ci­ne; ni­che pro­ducts, among others, for oph­thal­mo­lo­gy and can­cer the­ra­py: Chem­Con GmbH in Frei­burg, Ger­ma­ny spe­cia­li­zes in ac­ti­ve phar­maceu­ti­cal in­gre­di­ents and fine che­mi­cals of the hig­hest qua­li­ty. For cli­ni­cal tri­als or rare di­se­a­ses, of­ten only small amounts of an ac­ti­ve in­gre­di­ent are nee­ded. This is the ni­che co­ver­ed by Chem­Con. From smal­lest quan­ti­ties up to se­ve­ral hundred ki­lo­grams are pro­du­ced here per year. In this field in par­ti­cu­lar, the grea­test pos­si­ble pre­cis­i­on and do­cu­men­ta­ti­on are essential.

Stan­dar­di­sed working in­s­truc­tions or Stan­dard Ope­ra­ting Pro­ce­du­res (SOP) help to de­li­ver con­sis­tent qua­li­ty. “Up­dating do­cu­ments, re­prin­ting, re­sig­ning, and in­va­li­da­ting the old do­cu­ments: The flood of pa­per­work had com­ple­te­ly over­whel­med us af­ter 25 ye­ars of com­pa­ny histo­ry,” says Ilka Noack, Vice Di­rec­tor of Qua­li­ty Assu­rance and Re­gu­la­to­ry Af­fairs at Chem­Con GmbH.

Due to the growth of the com­pa­ny du­ring the last 25 ye­ars to curr­ent­ly 130 em­ployees, the need for do­cu­men­ta­ti­on and thus do­cu­ments has in­creased si­gni­fi­cant­ly. Chem­Con strug­g­led with moun­ta­ins of pa­per. For ex­am­p­le: In the in­dus­try, a pro­duct syn­the­sis re­gu­la­ti­on can ea­si­ly com­pri­se 50 to 200 pa­ges. Up­dating and re­vi­sing syn­the­sis re­gu­la­ti­ons and work in­s­truc­tions took a lot of time in the tra­di­tio­nal way. Ima­gi­ne, for ex­am­p­le, a re­gu­la­ti­on of 20 pa­ges in which only a few sen­ten­ces need to be up­dated. De­spi­te the fact that the amount of work in­vol­ved was ma­na­geable, it was still a lot of work due to the need for se­ve­ral em­ployees to check new do­cu­ments and the cor­re­spon­ding num­ber of si­gna­tures to be managed.

ChemCon Auftragsanalytik GMP

Updating documents could take days

The of­ten ne­ces­sa­ry ad­apt­a­ti­on of do­cu­ments in­clu­ding prin­ting, dis­tri­bu­ti­on, and track­ing of the do­cu­ments plus in­va­li­da­ting the old ver­si­on as well as ar­chi­ving could take days for such an up­date. “The pi­les of pa­per on the desks were gro­wing,” says Ilka Noack, “the pro­ces­sing times were long and it felt cum­ber­so­me.” For small com­pa­nies and start-ups, this may still be a ju­s­ti­fia­ble ef­fort in some cir­cum­s­tances, but es­tab­lished com­pa­nies the size of Chem­Con with a con­sidera­ble pro­duct histo­ry must re­du­ce this ef­fort. Noack: “We had seen the need to get rid of pa­per whe­re we could.”

With this in mind, Chem­Con GmbH was loo­king for a di­gi­tal al­ter­na­ti­ve. Th­rough a mar­ket ana­ly­sis and the cor­re­spon­ding prio­ri­tiza­ti­on of the re­qui­re­ments, th­ree pro­vi­ders re­main­ed, which the com­pa­ny ex­ami­ned more clo­se­ly. Among the re­qui­re­ments was that a new di­gi­tal Do­cu­ment Con­trol could run on the company’s own ser­vers, not in the cloud. “We were loo­king for a smal­ler, fle­xi­ble com­pa­ny and did­n’t want a gi­ant pro­vi­der; this idea also paid off for us in the end,” de­scri­bes Ilka Noack. She con­ti­nues: “The cli­ent by Di­gi­tal Life Sci­ence GmbH was very ap­pe­al­ing in terms of ope­ra­ti­on and ap­pearance; other soft­ware was not as mo­dern and ra­ther old-fa­shio­ned, not as intuitive.”

Chem­Con GmbH star­ted small at first, with the eQMS so­lu­ti­on by Di­gi­tal Life Sci­en­ces and with the Trai­ning Ma­nage­ment. Work­flows for re­cor­ding and pro­ces­sing de­via­ti­ons (CAPA, Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tions) and the Ch­an­ge Con­trol (pro­cess) were also among the first pro­ces­ses that Chem­Con di­gi­ti­sed with the help of Di­gi­tal Life Sci­en­ces GmbH.

Digital Document Control saves paper and makes extensive follow-up work a thing of the past.

Key­word di­gi­tal Do­cu­ment Con­trol: This is par­ti­cu­lar­ly im­portant for Stan­dard Ope­ra­ti­on Pro­ce­du­res (SOP). How is a che­mi­cal ana­ly­sis to be pre­pared? How is a pro­duct to be ma­nu­fac­tu­red or tes­ted? What test pa­ra­me­ters must be ob­ser­ved? What must be ta­ken into ac­count in the event of de­via­ti­ons? What to do when a ma­chi­ne dis­plays an er­ror code?

Chem­Con GmbH has stan­dar­di­sed work in­s­truc­tions for all pro­ces­ses that are cru­cial for the qua­li­ty of the pro­ducts. This also in­cludes log­books for the do­cu­men­ta­ti­on of e.g. pro­cess pa­ra­me­ters, forms, the do­cu­men­ta­ti­on of ship­ping, in­co­ming goods, and much more.

“We now use mas­ter do­cu­ments for many of the­se pro­ces­ses,” Noack de­scri­bes, “and that me­ans we al­ways have an up-to-date ver­si­on. The­re are no more lo­cal co­pies and no more out­da­ted pa­pers in file fol­ders. All con­trol­led do­cu­ments, such as SOPs, are also up to date at the re­le­vant work­sta­tions only mo­ments af­ter they are updated.”

Any un­clear points in SOPs can now be re­sol­ved more quick­ly. Sin­ce the pro­cess is ea­sier, the em­ployees are of­ten also more mo­ti­va­ted to quick­ly re­sol­ve is­sues. With just a few clicks, the re­vi­sed ver­si­ons are on their way to the col­le­agues who re­view the do­cu­ments. “I also al­ways exact­ly know whe­re a do­cu­ment is curr­ent­ly lo­ca­ted in the re­lease pro­cess,” sta­tes Ilka Noack, “and I can re­mind some col­le­agues or ask so­meone else if the per­son ac­tual­ly re­spon­si­ble is on va­ca­ti­on, for example.”

Pa­per is pa­ti­ent, they used to say. To­day, the di­gi­tal Do­cu­ment Con­trol au­to­ma­ti­cal­ly re­minds you of pas­sed dead­lines. For ex­am­p­le, when crea­ting and cor­rec­ting SOPs or re­cor­ding de­via­ti­ons. Ad­di­tio­nal­ly, cor­rec­tions and im­pro­ve­ments made to SOPs do not have to wait un­til the next re­vi­si­on, but can be op­ti­mi­sed wi­t­hout loss of time short­ly af­ter the weak point be­co­mes known.

Digital training management shows Quality Managers the current overview of trainings at all times

Whe­re the­re used to be pi­les of pa­per on desks, to­day a tidy over­view in di­gi­tal do­cu­ment con­trol shows which do­cu­ments still need to be up­dated, che­cked, or even lear­ned. And Ilka Noack has a bird’s eye view of all do­cu­ments and trai­nings that are curr­ent­ly be­ing pro­ces­sed. “This has be­co­me so much ea­sier and bet­ter with Di­gi­tal Life Sci­en­ces,” says the Qua­li­ty Ma­na­ger, “not only in re­gards to the pro­duc­tion and up­dating do­cu­ments, but espe­ci­al­ly when it co­mes to trai­ning management.”

As Qua­li­ty Ma­na­ger, Ilka Noack now al­ways has an up-to-date over­view of em­ployee qua­li­fi­ca­ti­ons. This way, she knows exact­ly which em­ployee has al­re­a­dy com­ple­ted a cer­tain trai­ning and whe­re con­tent is still pen­ding: “It’s a key be­ne­fit that you can see via each colleague’s sta­tus what they still need to be trai­ned in and what trai­nings they have al­re­a­dy com­ple­ted.” If a pro­ject is ever pau­sed or re­vi­sed, Noack can wi­th­draw the re­le­vant do­cu­ments with just a few mou­se clicks.

Analytik Labor Ionenchromatographie

Summary: By using digital solutions by Digital Life Sciences, ChemCon GmbH benefits from these advantages

  • Fas­ter, ea­sier ac­cess to do­cu­ments that are al­ways up to date, e.g. via search mask and mou­se click — no more time-con­sum­ing sear­ching th­rough stacks of paper
  • Cur­rent over­view of the sta­tus of em­ployee trai­nings and e‑learnings: Which trai­nings have the in­di­vi­du­al em­ployees al­re­a­dy com­ple­ted? Which trai­nings are still pen­ding? Mo­bi­le ac­cess is also pos­si­ble, for ex­am­p­le via ta­blet or smartphone
  • Trou­ble-free crea­ti­on and up­dating of work in­s­truc­tions (SOPs), no more time was­ted sear­ching th­rough stacks of pa­per, no more out­da­ted SOPs due to lo­cal co­pies or su­per­se­ded binders
  • Simp­le and al­ways up-to-date do­cu­men­ta­ti­on and pro­ces­sing of de­via­ti­ons (CAPA)
  • Wi­th­dra­wal and re­vi­si­on of do­cu­ments pos­si­ble with a few clicks
  • Sa­ving of working time which was de­si­gna­ted just for the phy­si­cal hand­ling of paper
  • si­gni­fi­cant pa­per savings

Up to 40 percent of working time is vacated thanks to digital Document Control. 

The switch to di­gi­tal Do­cu­ment Con­trol sa­ves Chem­Con GmbH se­ve­ral 10,000 pa­ges of pa­per per year, which does not only have a mo­ne­ta­ry im­pact, but also si­gni­fi­cant­ly im­pro­ves the company’s sustainability.

Di­gi­tal do­cu­ments can be found, pro­ces­sed and for­ward­ed in a split se­cond, and the en­ti­re ef­fort of prin­ting, fil­ing, dis­tri­bu­ting in­clu­ding time-con­sum­ing ma­nu­al track­ing is now no lon­ger re­qui­red. “We wan­ted to ad­apt our in­ter­nal busi­ness pro­ces­ses to di­gi­tal work­flows,” de­scri­bes Ilka Noack, “we made a con­scious de­cis­i­on to do so. This has made the com­pa­ny as a who­le more ef­fi­ci­ent. When deal­ing with do­cu­ments, we save 30 to 40 per­cent of working time.”

Each pro­cess and work­flow is now tag­ged with at­tri­bu­tes, al­lo­wing em­ployees to fil­ter tar­ge­ted in­for­ma­ti­on in se­conds in­s­tead of ha­ving to search th­rough tall stacks of pa­per. Out­da­ted prin­touts and lo­cal co­pies be­co­me no lon­ger ne­ces­sa­ry as well as ac­ci­den­tal­ly pas­sed dead­lines for e.g. the pro­ces­sing of SOPs or deviations.

Ilka Noack: “We have never re­g­ret­ted choo­sing the di­gi­tal Do­cu­ment Con­trol by Di­gi­tal Life Sci­en­ces. It was the right de­cis­i­on from the start. In the cour­se of the pro­ject rea­liza­ti­on, a part­ner-like re­la­ti­onship has been es­tab­lished with our cont­act per­sons. Our part­ners also cont­act us proac­tively to dis­cuss new ide­as. Ever­y­thing hap­pens much fas­ter and less cum­ber­so­me than we know from other im­ple­men­ta­ti­on pro­jects. Di­gi­tal Life Sci­en­ces is not just a ser­vice pro­vi­der, they work re­al­ly gre­at with us.”

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