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Without risks and side effects

“Tog­e­ther with the team of d.velop Life Sci­en­ces, we have im­ple­men­ted our new DMS and trai­ning tool with GMP-com­pli­an­ce in a very short time. Due to the com­pe­tent con­sul­ting, a prag­ma­tic so­lu­ti­on for every pro­blem was quick­ly found and also the drea­ded data mi­gra­ti­on from our old sys­tem was suc­cess­ful thanks to the da­ta­ba­se spe­cia­lists of d.velop. With the in­tro­duc­tion of DMS and EQM and the com­mit­ment of d.velop, we have mas­te­red a big step towards sys­tem op­ti­miz­a­ti­on. The en­ter­pri­se team of Hen­nig Arz­nei­mit­tel says Thank you and we’d be plea­sed to do it again!”

Meike Murawski
Mei­ke Murawski
QS Ma­na­ger Va­li­da­ti­on and Pro­jects (HENNIG ARZNEIMITTEL GmbH & Co. KG)

How the family business Hennig Arzneimittel benefits from a modern eDMS/eQMS

The me­di­cal and phar­maceu­ti­cal in­dus­try is struggling with high le­gal re­qui­re­ments for the ma­nage­ment of do­cu­ments. The­re­fo­re, the fa­mi­ly-ow­ned com­pa­ny Hen­nig Arz­nei­mit­tel re­li­es on a do­cu­ment and qua­li­ty ma­nage­ment sys­tem (eDMS/eQMS) by d.velop Life Sci­en­ces — and ac­ce­le­ra­tes work pro­ces­ses at the same time.

The histo­ry of Hen­nig Arz­nei­mit­tel goes back to the year 1898. Max E. Hen­nig, a 23-year-old che­mist, foun­ded the com­pa­ny in Ber­lin. In the be­gin­ning he ex­clu­si­ve­ly pro­du­ced tinc­tures from or­gan and plant ex­tracts. To­day, more than 120 ye­ars la­ter, the com­pa­ny in Flörs­heim am Main in Hes­se has grown into a me­di­um-si­zed en­ter­pri­se with 330 em­ployees and spe­cia­li­ses in the pro­duc­tion and mar­ke­ting of nu­me­rous me­di­ci­nal pro­ducts, me­di­cal de­vices and food sup­ple­ments, in­clu­ding a pre­pa­ra­ti­on for the tre­at­ment of ver­ti­go and ba­lan­ce disorders.

Like all com­pa­nies in the life sci­en­ces sec­tor, Hen­nig Arz­nei­mit­tel is also con­fron­ted with strict re­gu­la­ti­ons. The phar­maceu­ti­cal com­pa­ny must ful­ly do­cu­ment all work in­st­ruc­tions, test spe­ci­fi­ca­ti­ons and me­thods used in the ma­nu­fac­tu­re of me­di­ci­nal pro­ducts. Sin­ce 2011, the com­pa­ny has per­for­med this task with an elec­tro­nic do­cu­ment ma­nage­ment sys­tem (DMS). Em­ployees thus have quick ac­cess to do­cu­ments — the as­si­stant at the in­co­m­ing goods de­part­ment, for ex­amp­le, has ac­cess to check­lists for goods ac­cep­t­ance while the em­ployee in pro­duc­tion can see new hy­gie­ne regulations.

No updates, no support: Old DMS made everyday work more difficult

Pa­per and filing ca­bi­nets should have been a thing of the past thanks to the DMS. In theo­ry. Sin­ce the ma­nu­fac­tu­rer of the DMS disap­peared from the mar­ket, the­re was no sup­port and no more up­dates. A vo­la­ti­le si­tua­ti­on: “By law, we are re­qui­red to keep all risks un­der con­trol. We the­re­fo­re made back­up co­pies of all do­cu­ments, prin­ted them and fi­led them — just in case the DMS sud­den­ly stop­ped working,” re­calls Mei­ke Mu­raw­ski, QA Ma­na­ger Va­li­da­ti­on and Pro­jects at Hen­nig Arz­nei­mit­tel. Kind of a back­wards roll in terms of di­gi­tiz­a­ti­on. De­s­pi­te DMS the filing ca­bi­nets were full.

In or­der to in­cre­a­se se­cu­ri­ty and pre­vent me­dia dis­rup­ti­ons, Hen­nig Arz­nei­mit­tel wan­ted to re­place the old DMS with a new so­lu­ti­on as quick­ly as pos­si­ble. “We re­se­ar­ched DMS ven­dors in the phar­maceu­ti­cal sec­tor and con­ta­c­ted three ma­nu­fac­tu­rers,” says Mu­raw­ski. “In the pro­cess, we quick­ly rea­li­zed that we sym­pa­thi­zed most with d.velop’s ex­perts and trus­ted their ex­pe­ri­ence the most.” d.velop Life Sci­en­ces ser­ves about 100 cus­to­mers, a ma­jo­ri­ty of whom are in the va­li­da­ted GxP en­vi­ron­ment, most­ly in me­di­cal tech­no­lo­gy or phar­maceu­ti­cal environments. 

New DMS puts an end to annoying paper backups

Tog­e­ther with d.velop Life Sci­en­ces, Hen­nig Arz­nei­mit­tel has set up a new do­cu­ment ma­nage­ment sys­tem bet­ween Oc­to­ber 2019 and March 2020. The DMS con­tains all work in­st­ruc­tions, ma­nu­fac­tu­ring and test spe­ci­fi­ca­ti­ons as well as qua­li­fi­ca­ti­on cer­ti­fi­ca­tes of the em­ployees. “We now fi­nal­ly have a mo­dern DMS with a re­li­able con­ta­ct per­son and no lon­ger have to worry about de­fault risks,” Mu­raw­ski is plea­sed to say. “This also me­ans the end of cum­ber­so­me pa­per back­ups, which have un­ne­cessa­ri­ly con­su­med re­sour­ces and space in the past.”

The new DMS also speeds up the si­gna­tu­re ma­nage­ment. If em­ployees re­cei­ve an in­st­ruc­tion, for ex­amp­le for a new garment in pro­duc­tion, they must con­firm with an elec­tro­nic si­gna­tu­re that they have ack­now­led­ged the SOP (Stan­dard Ope­ra­ting Pro­ce­du­re). The ad­mi­nis­tra­ti­ve bur­den is high in the tra­di­tio­nal pa­per-ba­sed way. The elec­tro­nic si­gna­tu­re saves time. In­s­tead of si­gning ma­nu­al­ly, the em­ployee con­firms the ack­now­led­ge­ment of the do­cu­ment in the DMS with user name and pass­word. The e‑signature is le­gal­ly equi­va­lent to a ma­nu­al si­gna­tu­re here.

The DMS provides basis for regulatory compliance 

Thanks to the new DMS, Hen­nig Arz­nei­mit­tel also be­ne­fits from le­gal­ly com­pli­ant ar­chi­ving. “We have to face ex­cep­tio­nal­ly high do­cu­ment ma­nage­ment re­qui­re­ments in the life sci­ence in­dus­try. With our DMS we ma­na­ge and ar­chi­ve all elec­tro­nic do­cu­ments in a le­gal­ly com­pli­ant man­ner. It is the­re­fo­re the ba­sis for le­gal­ly com­pli­ant work,” ex­p­lains Mu­raw­ski. Mo­reo­ver do­cu­ments can be found in se­conds using key­words, me­ta­da­ta, full text and fa­ce­ting. “The sys­tem is in­tui­ti­ve to un­der­stand. We can view se­arch re­sults in de­tail and save se­arch tem­pla­tes — that’s espe­cial­ly han­dy if you per­form re­gu­lar evaluations.”

“d.velop is really an absolute professional in the field of migration”

As in­tui­ti­ve as the new func­tions of the DMS are — the chan­ge from the old to the new so­lu­ti­on was not. d.velop was fa­ced with the chal­len­ge of mi­gra­ting thousands of elec­tro­nic do­cu­ments from a sys­tem that was no lon­ger main­tai­ned — in­clu­ding their me­ta­da­ta. Mista­kes were not al­lo­wed to hap­pen. They could jeo­par­di­ze the dai­ly work rou­ti­ne. For ex­amp­le, if em­ployees sud­den­ly start working ac­cord­ing to wrong ma­nu­fac­tu­ring in­st­ruc­tions or if pro­ofs of qua­li­fi­ca­ti­on get mi­xed up. “The mi­gra­ti­on of the do­cu­ments with their me­ta­da­ta and the cor­rect mer­ging in the new DMS were some of the big­gest chal­len­ges of this pro­ject”, ex­p­lains Dr. Den­nis Sand­küh­ler, Pro­ject Ma­na­ger at d.velop Life Sciences.

The mi­gra­ti­on was dif­fi­cult be­cau­se the­re were no in­ter­faces bet­ween the old and new DMS. This me­ant that the­re were ob­sta­cles in the way of au­to­ma­tic data trans­fer. “We the­re­fo­re ana­ly­zed the spe­ci­fics of the old and new sys­tems and de­ve­lo­ped a small, cus­to­mi­zed mi­gra­ti­on tool,” says Sand­küh­ler. “Af­ter mi­gra­ti­on tes­ting, we were fi­nal­ly able to use the soft­ware to au­to­ma­ti­cal­ly trans­fer data from the old DMS to the new one.” The mi­gra­ti­on was com­ple­ted wi­t­hin one day, con­firms Mu­raw­ski. “d.velop works re­al­ly pro­fes­sio­nal­ly in this area.”

Nice bonus: New tool optimizes management of training courses 

In or­der to op­ti­mi­ze the ma­nage­ment of trai­nings, Hen­nig Arz­nei­mit­tel has also im­ple­men­ted a new trai­ning tool from d.velop par­al­lel to the DMS. The for­mer so­lu­ti­on col­li­ded with the ope­ra­ting sys­tem of the EDP and was no lon­ger up­date­ab­le. “The old sys­tem also of­fe­red only poor per­for­mance, espe­cial­ly with lar­ge num­bers of par­ti­ci­pants, and cras­hed too of­ten,” Mu­raw­ski re­calls. “The­se pro­blems have now been sol­ved by the new trai­ning tool. We now plan and do­cu­ment trai­nings for em­ployees bet­ter than ever.”

The trai­ning ma­nage­ment tool is di­rect­ly lin­ked to the DMS. A qua­li­fi­ca­ti­on ma­trix in­forms de­part­ment ma­na­gers about the cur­rent trai­ning sta­tus of em­ployees at the push of a but­ton. This trans­pa­ren­cy did not exist in the past be­cau­se the IT de­part­ment had to run the old tool on a se­pa­ra­te ter­mi­nal ser­ver — it was no lon­ger com­pa­ti­ble with the ope­ra­ting sys­tem cur­r­ent­ly used by the IT de­part­ment. With this makes­hift so­lu­ti­on, howe­ver, only qua­li­ty as­suran­ce had ac­cess to the ser­ver, but not the de­part­ment ma­na­gers. The coor­di­na­ti­on ef­fort was cor­re­spon­din­gly high.

Using the new tool, howe­ver, it is not only pos­si­ble to check the sta­tus quo of trai­ning cour­ses. Hen­nig Arz­nei­mit­tel also crea­tes qua­li­fi­ca­ti­on pro­files and as­signs them to the re­le­vant do­cu­ments. The tool is also sui­ta­ble for crea­ting ques­ti­on ca­ta­logs or mul­ti­ple-choice tasks for trai­ning cour­ses. Af­ter suc­cess­ful pro­ces­sing, it au­to­ma­ti­cal­ly up­dates the employee’s qua­li­fi­ca­ti­on sta­tus in the qua­li­fi­ca­ti­on matrix. 

“The next thing we want to do is digitize the change control management”

Hen­nig Arz­nei­mit­tel has been using DMS and trai­ning ma­nage­ment tool sin­ce July 2020. And is con­vin­ced of d.velop: “We found the col­la­bo­ra­ti­on to be both pur­po­se­ful and coope­ra­ti­ve. Tog­e­ther we have im­ple­men­ted a so­lu­ti­on that makes our ever­y­day work safer and more pro­duc­ti­ve,” con­clu­des Mu­raw­ski. The next pro­ject is al­rea­dy rea­dy to go. “Cur­r­ent­ly, con­trol­led chan­ge ma­nage­ment in our ope­ra­ti­on is still con­duc­ted on pa­per. In 2021, we want to com­pu­te­ri­ze the Chan­ge Con­trol Ma­nage­ment with pro­ducts of d.velop. And in do­ing so, take our di­gi­tiz­a­ti­on one step further.”

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