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Digital QM and training management for laboratory network amedes group

“Pri­or to 2016, we did have an elec­tro­nic do­cu­ment rou­ting sys­tem in place, but it was all not as clean and per­for­mant as it should have been.For ex­am­p­le, we missed a good over­view of which em­ployee is trai­ned to what ext­ent. That’s what we have to­day thanks to Di­gi­tal Life Sci­en­ces. This is im­portant, for ex­am­p­le, for an ex­ter­nal au­dit. With the old sys­tem, we still had to do many things ma­nu­al­ly. With Di­gi­tal Life Sci­en­ces’ eQMS so­lu­ti­on, qua­li­ty and speed have ta­ken a leap upward.”

Yvonne Kraska, Abteilungsleiterin QM, amedes-Gruppe
Yvonne Kras­ka
Head of QM De­part­ment (ame­des group)

It’s one thing to have to re­trie­ve thou­sands of do­cu­ments every day, check them and keep track of which em­ployees have al­re­a­dy read them and which still need to catch up. But it’s quite an­o­ther thing to be re­spon­si­ble for this in the me­di­cal sector.

The ame­des group does just that. It pro­vi­des me­di­cal-dia­gno­stic ser­vices for pa­ti­ents, prac­ti­cing phy­si­ci­ans and cli­nics. To this end, ame­des has over 4000 em­ployees at more than 90 lo­ca­ti­ons. Across Ger­ma­ny, the group ser­ves around 40 cli­nics, and spe­ci­al­ly trai­ned em­ployees edit more than 400,000 la­bo­ra­to­ry ana­ly­ses every day. In this way, ame­des spe­cia­lists tre­at over 450,000 pa­ti­ents a year.

It goes wi­t­hout say­ing that all the steps have to be per­fect and flaw­less. A key fac­tor for this high qua­li­ty stan­dard is the me­ti­cu­lous main­ten­an­ce of qua­li­ty ma­nage­ment ma­nu­als and do­cu­ments. For­t­u­na­te are tho­se who can use a strong and easy-to-ope­ra­te di­gi­tal qua­li­ty ma­nage­ment sys­tem for this purpose.

“Be­fo­re 2016, we did have an elec­tro­nic sys­tem in place to ma­na­ge do­cu­ments,” de­scri­bes Yvonne Kras­ka, head of QM at the ame­des group, “but none of that was as clean or as per­for­mant as it should have been.” For ex­am­p­le, the com­pa­ny la­cked a clear real-time over­view of which em­ployee had al­re­a­dy read which do­cu­ment or work in­s­truc­tion and also ack­now­led­ged this by signature.

It also la­cked the abili­ty to as­sign do­cu­ments to spe­ci­fic em­ployees. Some sites could not be trai­ned di­gi­tal­ly and the­r­e­fo­re used a pa­per pro­cess ra­ther than a di­gi­tal re­a­ding con­fir­ma­ti­on. “Af­ter re­vie­w­ing do­cu­ments, some em­ployees were still able to make ch­an­ges with the old sys­tem,” Ms. Kras­ka de­scri­bes, “We wan­ted that to be different.”

Nahaufnahme einer Gruppe von Wissenschaftlern und Pharmazeuten im Labor.

Transparency and overview in quality management

In search of an al­ter­na­ti­ve, the ame­des group came across the Do­cu­ment Con­trol mo­du­le from Di­gi­tal Life Sci­en­ces GmbH. “We loo­ked at a lot of sys­tems,” said Yvonne Kras­ka, “and Di­gi­tal Life Sci­en­ces made a dif­fe­rence like night and day. Many al­ter­na­ti­ves were not com­pa­ra­ble at all. Of cour­se, we also had to make some sacri­fices and de­ci­de which sys­tem we wan­ted to live with. Af­ter all, a sin­gle sys­tem can­not take ever­y­thing into ac­count from the very be­gin­ning. It was then that we said, in per­spec­ti­ve, we want to con­ti­nue working with Di­gi­tal Life Sciences.”

Forms, work in­s­truc­tions, qua­li­ty ma­nu­als, trai­ning do­cu­ments, and cus­to­mer in­voices: The ame­des group and Di­gi­tal Life Sci­en­ces GmbH joint­ly trans­fer­red the­se do­cu­ment ty­pes to the new do­cu­ment ma­nage­ment sys­tem in a very short time. Do­cu­ments from the sec­tions of qua­li­ty ma­nage­ment, ma­nu­als and trai­ning do­cu­ments were in­iti­al­ly gi­ven prio­ri­ty. “One ex­am­p­le,” says Frank Lau­mann, Di­rec­tor Ser­vices at Di­gi­tal Life Sci­en­ces GmbH, “is the work in­s­truc­tion on hy­gie­nic hand wa­shing. If you main­tain 40 sites, you must main­tain this in­s­truc­tion 40 times. To­day, the ame­des group has a cen­tral di­gi­tal do­cu­ment that only needs to be ma­na­ged once.”

If the cen­tral di­gi­tal do­cu­ment is ch­an­ged, the ch­an­ges are available al­most si­mul­ta­neous­ly at all lo­ca­ti­ons. And Yvonne Kras­ka can check vir­tual­ly in real time which em­ployee has al­re­a­dy ta­ken note of and si­gned the up­dated do­cu­ment. The new di­gi­tal work­flow with di­gi­tal do­cu­ment con­trol also sa­ves steps and pa­per when crea­ting new documents.

In 2017–2018, va­rious in­di­vi­du­al con­tracts, cor­po­ra­te le­gal do­cu­ments, mas­ter agree­ments, pa­tents, trade­marks and sup­pli­er agree­ments were added.

Digital document control process with several participants

Wri­te or crea­te, re­view and sign do­cu­ments: “With the di­gi­tal Do­cu­ment Con­trol, the ame­des group now has si­gni­fi­cant time sa­vings,” de­scri­bes Frank Lau­mann, “if only be­cau­se tasks and pa­pers come in via e‑mail and can be di­gi­tal­ly si­gned im­me­dia­te­ly.” The ame­des group curr­ent­ly uses di­gi­tal si­gna­tures only for in­ter­nal pur­po­ses, so a com­pa­ra­tively simp­le le­gi­ti­miza­ti­on of users th­rough their log­in into the company’s own sys­tem is sufficient.

Many em­ployees work tog­e­ther to crea­te do­cu­ments. As with many pro­ces­ses in busi­ness, the­re is a bot­t­len­eck: “Ty­pi­cal­ly that’s the re­view­ers,” says Ms Kras­ka, “which in most ca­ses is one of our em­ploy­ed doc­tors, and they’­re ex­tre­me­ly busy.” So far, so usu­al, so hard­ly avo­ida­ble. But the new soft­ware sa­ves the ame­des group a lot of ex­tra re­sour­ces that used to be lost bet­ween the in­di­vi­du­al pro­cess steps.

It used to be cal­led: Wri­te, print, trans­port. Re­view. Then sign. Trans­port again. Copy. File. Ar­chi­ve. At each step of the pro­cess, em­ployees could lose sight of the is­sue, mis­file a fol­der, bring other tasks for­ward. In the worst case, this could cost the com­pa­ny days. “To­day, ide­al­ly, it ta­kes us 30 mi­nu­tes to have a new do­cu­ment re­view­ed and cir­cu­la­ted,” de­scri­bes Yvonne Kras­ka. “We save the run­ning around, the run­ning af­ter, the co­py­ing, the ma­nu­al fil­ing and ar­chi­ving. The sys­tem also au­to­ma­ti­cal­ly re­minds col­le­agues of any ex­pi­ring deadlines.”

Konzept der Dokumentenverwaltung, Geschäftsmann nutzt Computer zur Dokumentation

Digital proofs of training: legally secure and traceable

Scru­pu­lous­ly fol­lo­wing work in­s­truc­tions is a key fac­tor for suc­cess, espe­ci­al­ly in the me­di­cal sec­tor. Af­ter all, no pa­ti­ent wants to re­cei­ve fal­se test re­sults. “Does an ob­ject need to be co­lo­red blue or red? A bot­t­le to be pla­ced on the left or right? What does a col­le­ague do when a de­vice re­ports an er­ror?” Yvonne Kras­ka re­mem­bers: “In the past, the­re were si­gna­tu­re lists on pa­per, so­me­ti­mes even stap­led to cer­tain do­cu­ments. Ch­an­ges were mark­ed, so­me­ti­mes had to be prin­te­dout, be­cau­se it was not pos­si­ble to go pa­per­less ever­y­whe­re. And the ack­now­led­ge­ment was con­firm­ed manually.”

This ma­nu­al pro­cess meant a lot of work due to fre­quent checks. This ad­di­tio­nal ef­fort is now sa­ved by the en­ti­re group. In most ca­ses, elec­tro­nic do­cu­ments are also ack­now­led­ged elec­tro­ni­cal­ly, and the sys­tem logs the si­gna­tures. Ms. Kras­ka: “I can see in the sys­tem what’s hap­pe­ning. From all over the world, if I want, I can see who has al­re­a­dy si­gned and who still needs to ack­now­ledge a do­cu­ment.” The re­a­ding con­fir­ma­ti­on is GxP com­pli­ant and traceable. “That’s im­portant,” Ms. Kras­ka said, “for an ex­ter­nal au­dit, for example.”

The ame­des group has ac­cess to this in­for­ma­ti­on, among others:

  • Which do­cu­ment hangs in which cor­rec­tion status?
  • Which work in­s­truc­tion ap­pli­es at which site?
  • What is the sta­te of ver­sio­ning of cer­tain documents?
  • Which do­cu­ments are as­si­gned to which employee?

The in­for­ma­ti­on can also be ac­ces­sed on the move, for ex­am­p­le via smart­phone or ta­blet. For the la­bo­ra­to­ry net­work, the time sa­vings in par­ti­cu­lar are a de­cisi­ve ad­van­ta­ge. Ms. Kras­ka: “In the past, it felt like we were still working on foot a lot.”

Central digital business processes of the amedes group with digital Document Control

  • Crea­ti­on, re­view, re­vi­si­on and ar­chi­ving of documents
  • Fol­low-up of trai­nings and ack­now­led­ge­ment of e.g. work instructions
  • Ma­nage­ment and dis­tri­bu­ti­on of QM ma­nu­als at all sites
  • Out­put of e.g. work in­s­truc­tions to the cor­re­spon­ding workstations
  • Ar­chi­ving of cus­to­mer invoices
  • Ma­nage­ment of con­tracts (pri­ma­ri­ly internal)
  • Uni­form spe­ci­fi­ca­ti­on of do­cu­ment tem­pla­tes and layouts

Yvonne Kraska’s con­clu­si­on: “With the old sys­tem, we still had to do many things ma­nu­al­ly. With the eQMS so­lu­ti­on from Di­gi­tal Life Sci­en­ces GmbH and the d.velop do­cu­ments plat­form from d.velop AG, qua­li­ty and speed have ta­ken a leap upward.”

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