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Corden Pharma speeds up processes by 20 percent with digital document control

“d.velop Life Sci­en­ces has hel­ped us make our pa­per-ba­sed pro­ces­ses more di­gi­tal. In the past, we main­ly prin­ted out a lot of things, stam­ped them, si­gned them and tran­sac­ted them on pa­per or with of­fice do­cu­ments. Some things had to be kept in hard­co­py form for ye­ars. To­day, we work with real di­gi­tal do­cu­ments that we can dis­tri­bu­te with just a few clicks, re­gard­less of whe­ther the em­ployees in ques­ti­on are cur­r­ent­ly working at home or so­me­whe­re else. Pro­ces­ses have be­co­me at least 20 per­cent faster.”

Witali Blum - QA Manager / Qualification Expert - Corden Pharma Switzerland LLC
Dr.-Ing. Wi­ta­li Blum
Qua­li­fi­ca­ti­on Ex­pert (Cor­den Phar­ma Switz­er­land LLC)

Pain­kil­lers, in­su­lin, vac­ci­nes and much more: The phar­maceu­ti­cal in­dus­try is a sup­por­ting pil­lar of the he­alth­ca­re sys­tem. In Ger­ma­ny alo­ne, more than 500 phar­maceu­ti­cal com­pa­nies ma­nu­fac­tu­red drugs and phar­maceu­ti­cal pro­ducts worth around 31 bil­li­on eu­ros in 2020. Com­pa­nies like Cor­den Phar­ma Switz­er­land LLC. As part of Cor­den Phar­ma In­ter­na­tio­nal, with eight clo­se­ly coope­ra­ting sites world­wi­de, it is a ma­jor pro­vi­der of ac­ti­ve in­gre­dients and ser­vices in the are­as of de­ve­lo­p­ment as well as ma­nu­fac­tu­ring of ac­ti­ve in­gre­dients for phar­maceu­ti­cals (CDMO, Con­tract De­ve­lo­p­ment & Manufacturing).

In ad­di­ti­on to eco­no­mic re­spon­si­bi­li­ty, the phar­maceu­ti­cal in­dus­try feels so­cial re­spon­si­bi­li­ty. The­re­fo­re, the­re are ex­ten­si­ve re­gu­la­ti­ons, ru­les, gui­de­li­nes. Many of the­se are known un­der the key term “GxP” as gui­de­li­nes for good work prac­ti­ces. “In the phar­maceu­ti­cal sec­tor the­re is ge­ne­ral­ly a very strong em­pha­sis on do­cu­men­ting pro­ces­ses. This also ap­p­lies to the do­cu­men­ta­ti­on of ma­nu­fac­tu­ring pro­ces­ses”, de­scri­bes Arne Ca­den­bach, Pro­ject Ma­na­ger at d.velop Life Sci­en­ces GmbH.

Corden Pharma Pharmaceutical Products

Meticulous documentation via hardcopy and office documents

In past ye­ars, Cor­den Phar­ma Switz­er­land LLC re­li­ed on a me­ti­cu­lous pro­cess in­vol­ving hard­co­py and of­fice do­cu­ments. Howe­ver, some ope­ra­ting or ma­nu­fac­tu­ring re­gu­la­ti­ons (BVO) turn out to be several hund­red pa­ges long. In ad­di­ti­on, Stan­dard Ope­ra­ting Pro­ce­du­res (SOP) were crea­ted, cor­rec­ted, re­leased, prin­ted and dis­tri­bu­t­ed to the ap­pro­pria­te em­ployees. They then had to sign a trai­ning re­cord to con­firm that they had read and in­ter­na­li­zed the new regulations.

“That’s whe­re we used Ex­cel spreads­he­ets, among other things, to keep track of who was trai­ned and when, with trai­ning re­cords as pro­of. That was a lot of work for qua­li­ty ma­nage­ment”, says Wi­ta­li Blum, Qua­li­fi­ca­ti­on Ex­pert at Cor­den Phar­ma, “if a work in­st­ruc­tion chan­ged, a new ver­si­on was pro­du­ced, and the who­le cir­cu­la­ti­on through ma­nu­fac­tu­ring, re­vi­si­on, re­lease, dis­tri­bu­ti­on and trai­ning had to be done again.”

This me­ant a lot of work for the Cor­den Phar­ma staff. An­yo­ne who has had to dis­cuss and agree on a long of­fice do­cu­ment with many em­ployees via email knows this. “Espe­cial­ly in the home of­fice, it can be even more dif­fi­cult to keep track of emails with mul­ti­ple file ver­si­ons if I have to mer­ge the ver­si­ons ma­nu­al­ly”, says Arne Cadenbach.

Main objective: Improve EQM and training

The good news: Such ac­ti­vi­ties are well sui­ted for di­gi­tal do­cu­ment con­trol. A soft­ware ap­p­li­ca­ti­on ma­na­ges the do­cu­ments, keeps tho­se in­vol­ved in touch and re­cords in me­ta­da­ta who made which chan­ge, re­lease, or si­gna­tu­re and when.

So in 2019, Cor­den Phar­ma Switz­er­land LLC set out to find a di­gi­tal do­cu­ment con­trol pro­vi­der. “In­iti­al­ly, the main goal was to im­pro­ve trai­ning”, re­calls Wi­ta­li Blum, “and d.velop Life Sci­en­ces was con­vin­cing right from the start. At first, di­gi­tal do­cu­ment ma­nage­ment was just an ac­ces­so­ry, but that has gra­du­al­ly mo­ved fur­ther and fur­ther to the front.”

The in­stal­la­ti­on of the di­gi­tal do­cu­ment con­trol sys­tem was com­ple­ted in one day; the data mi­gra­ti­on and soft­ware va­li­da­ti­on took con­si­der­ab­ly more time. In mid-2020, Cor­den Phar­ma was able to go live with the d.velop Life Sci­en­ces di­gi­tal do­cu­ment con­trol sys­tem. Blum: “We be­ne­fi­ted from the ex­pe­ri­ence d.velop Life Sci­en­ces has in va­li­da­ting software.”

It took a while for all em­ployees to get used to the new pro­ce­du­res. To train em­ployees, Cor­den Phar­ma and d.velop Life Sci­en­ces use the Key User Mo­del. A few selec­ted users re­cei­ve in­ten­si­ve one-day trai­ning and pass on the in­for­ma­ti­on wi­t­hin the com­pa­ny. The ad­mi­nis­tra­tors were fa­mi­lia­ri­zed with their tasks se­pa­r­ate­ly at a to­tal of two trai­ning sessions.

Corden Pharma Packaging Logistics Pharmaceutical Services

Key benefits of digital document control at Corden Pharma

Right at the be­gin­ning of the set­up pro­cess, it be­co­mes clear what the scope of the new soft­ware is. Pro­ces­ses can run fas­ter and more re­li­ab­ly, em­ployees are re­lie­ved and have more working time free for other im­portant tasks. Cor­den Phar­ma Switz­er­land LLC now maps the­se cen­tral points with the di­gi­ta­liz­a­ti­on so­lu­ti­ons of d.velop Life Sci­en­ces, in­clu­ding do­cu­ment control:

  • Pro­duc­tion, re­vi­si­on of work in­st­ruc­tions, Stan­dard Ope­ra­ting Pro­ce­du­res (SOP) and other do­cu­ments such as va­li­da­ti­on do­cu­ments, spe­ci­fi­ca­ti­ons, de­scrip­ti­on of pro­duc­tion pro­ces­ses, do­cu­men­ta­ti­on of test me­thods and many more
  • EQM Ma­nage­ment — Or­ga­niz­a­ti­on and fol­low-up of em­ployee qua­li­fi­ca­ti­on and trai­ning. For this, Cor­den Phar­ma uses elec­tro­nic si­gna­tu­re and au­to­ma­tic de­li­very of trai­ning tasks to the DMS mail­box of the par­ti­ci­pants: Once a new ver­si­on of a trai­ning ma­te­ri­al is com­ple­ted, it au­to­ma­ti­cal­ly lands in the task in­box of tho­se con­cer­ned. This also ap­p­lies to safe­ty training
  • Ar­chi­ving of documents
  • Re­lease pro­ces­ses with elec­tro­nic signature
  • Con­trol­led, trace­ab­le, up-to-date dis­tri­bu­ti­on and mai­ling of do­cu­ments — in­s­tead of so­me­ti­mes wai­t­ing days for pa­per mail to arrive
  • Me­ti­cu­lous do­cu­men­ta­ti­on of pro­ces­ses such as pro­duc­tion, re­lease and re­vi­si­on of do­cu­ments, also to the sa­tis­fac­tion of phar­maceu­ti­cal customers
  • Ever up-to-date do­cu­ments wi­thout big workload — the hunt for out­da­ted ver­si­ons is over

“Our work sim­ply runs fas­ter”, de­scri­bes Wi­ta­li Blum, “one ex­amp­le: In the past, when we nee­ded a phy­si­cal si­gna­tu­re, it took time if the per­son was working from home or on va­ca­ti­on at that time. To­day, they just get the do­cu­ment au­to­ma­ti­cal­ly into their di­gi­tal task mail­box for re­lease.” For the le­gi­ti­ma­ti­on of the di­gi­tal si­gna­tu­re Cor­den Phar­ma uses the Win­dows user ac­count. This en­su­res the au­then­ti­ci­ty of the si­gna­tu­re for in­ter­nal pro­ces­ses. Also many of Cor­den Pharma’s cus­to­mers, who re­qui­re some si­gna­tures in ma­nu­fac­tu­ring or pro­ces­sing pro­ce­du­res, for ex­amp­le, agree with this process.

“The human error has become smaller”

“The tracea­bi­li­ty has sim­ply got­ten bet­ter”, Blum says, “and the di­gi­tal pro­ces­ses have re­du­ced hu­man er­ror in tracking ver­si­ons that are in cir­cu­la­ti­on, for ex­amp­le. The d.3 life sci­en­ces sys­tem has done away with that in one swoop; we have be­co­me fas­ter and safer, very many te­dious work steps have fal­len away.”

On the busi­ness side, Cor­den Phar­ma also re­gis­ters a fi­nan­cial be­ne­fit. And the fas­ter and safer pro­ces­ses have freed up working time, which in turn be­ne­fits other are­as or ac­ti­vi­ties. Last but not least, pa­per con­sump­ti­on has also drop­ped — by half, as Blum no­tes. His con­clu­si­on: “Pro­ces­ses have be­co­me at least 20 per­cent faster.”

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