SCHOTT AG optimizes QM processes for document control and improves workflows worldwide with innovative electronic quality management system d.3 eQMS 

”His­to­ri­cal­ly, six of our busi­ness units had their own do­cu­ment ma­nage­ment sys­tem, purcha­sed spe­ci­fi­cal­ly and es­tab­lished their own struc­tu­re. With the in­tro­duc­tion of a new elec­tro­nic qua­li­ty ma­nage­ment sys­tem (eQMS), we wan­ted to op­ti­mi­ze, cen­tra­li­ze and har­mo­ni­ze co­ope­ra­ti­on in the qua­li­ty ma­nage­ment units. This way, the units can help each other much bet­ter. We were able to crea­te are­as, with do­cu­ments such as stan­dards, sets of ru­les or gui­de­lines, which all units need, but which only have to be main­tai­ned once. This al­lo­wed us to be­co­me more ef­fi­ci­ent and also save mo­ney. I would also like to high­light the va­li­da­ti­on of com­pu­ter-ba­sed sys­tems, whe­re Di­gi­tal Life Sci­en­ces has si­gni­fi­cant­ly hel­ped us” 

Christine Strubel
Chris­ti­ne Strubel
Head of “Ma­nage­ment Sys­tems Qua­li­ty & EHS” at SCHOTT AG

What do phar­maceu­ti­cal vi­als for the COVID-19 vac­ci­ne, cera­mic cook­tops and mir­rors for the world’s lar­gest op­ti­cal te­lescope have in com­mon? The high-tech pro­ducts are ma­nu­fac­tu­red by SCHOTT AG, an in­ter­na­tio­nal tech­no­lo­gy group with over 130 ye­ars of history.

It all star­ted at Otto Schott’s par­ents’ house in Wit­ten, whe­re the che­mist in­ven­ted a new type of glass in 1879 — li­thi­um glass. It had com­ple­te­ly new op­ti­cal pro­per­ties. The then 28-year-old sent a sam­ple of it to the re­now­ned phy­si­cist Ernst Abbe in Jena. A fruitful col­la­bo­ra­ti­on be­g­ins, Schott sett­les in Jena. The­re he in­vents a heat-re­sistant glass that does not shat­ter when boi­ling wa­ter is pou­red into it: Jena glass. One of the cor­ner­sto­nes of today’s SCHOTT AG with sub­si­dia­ries in 34 countries.

To­day, the AG is a sought-af­ter part­ner world­wi­de for in­dus­tri­al sec­tors re­qui­ring goods at the spear­head of tech­no­lo­gi­cal de­ve­lo­p­ment: me­di­ci­ne, phar­maceu­ti­cals, elec­tro­nics, op­ti­cal ap­pli­ca­ti­ons, power ge­ne­ra­ti­on, au­to­mo­ti­ve, ae­ro­space and, last but not least, as­tro­no­my. In 2021, the ap­pro­xi­m­ate­ly 16,500 em­ployees ge­ne­ra­ted sa­les of over 2.5 bil­li­on euros.

SCHOTT AG has be­co­me in­dis­pensable in the phar­maceu­ti­cal in­dus­try, among others. With over 600 pro­duc­tion li­nes in 13 count­ries, the com­pa­ny ma­nu­fac­tures over 11 bil­li­on sy­rin­ges, vi­als, am­poules and spe­cial­ty items. SCHOTT re­li­es on sel­ec­ted raw ma­te­ri­als and the most re­lia­ble and la­test pro­duc­tion pro­ces­ses. As a re­sult, the com­pa­ny could ship more than one bil­li­on vi­als of COVID-19 vac­ci­ne by ear­ly March 2021.

In this con­text, SCHOTT not only re­li­ed on sta­te-of-the-art ma­nu­fac­tu­ring me­thods, but also on up-to-date soft­ware to ma­na­ge do­cu­ments and com­ply with do­cu­men­ta­ti­on ob­li­ga­ti­ons and other re­qui­re­ments for pro­ces­ses in the phar­maceu­ti­cal in­dus­try. So far, so good.

SCHOTT AG company building Image: ©SCHOTT

Central management of the d.3 eQMS, but room for maneuver for each business unit due to structuring by client

But the de­vil hid in the de­tails. Se­ve­ral busi­ness units and cor­po­ra­te func­tions at va­rious lo­ca­ti­ons world­wi­de used the exis­ting do­cu­ment ma­nage­ment sys­tem: Ad­van­ced Op­tics, Home­tech, Light­ing and Ima­ging, Re­se­arch and De­ve­lo­p­ment (R&D), as well as the Ac­cre­di­ted Test La­bo­ra­to­ries of SCHOTT AG. The only catch was that each unit bought the soft­ware its­elf, es­tab­lished its own struc­tu­re and used the exis­ting soft­ware in its own way. Re­gu­la­ti­ons had to be found that en­ab­led the cli­ents to sup­port their re­spec­ti­ve pro­ces­ses in the pro­duc­tion en­vi­ron­ment or the cor­po­ra­te func­tions with the do­cu­ment con­trol and to ful­fill the qua­li­ty-re­le­vant re­qui­re­ments world­wi­de. ”Ul­ti­m­ate­ly, all units strug­g­led with the same do­cu­ment con­trol chal­lenges. We wan­ted to cen­tra­li­ze and har­mo­ni­ze that”, says Chris­ti­ne Stru­bel, head of “Ma­nage­ment Sys­tems Qua­li­ty & EHS”.

Thus, the in­ter­na­tio­nal ori­en­ta­ti­on and avai­la­bi­li­ty of se­ve­ral lan­guages was also an im­portant cri­ter­ion in the sel­ec­tion of a new do­cu­ment and qua­li­ty ma­nage­ment system.

In the age of di­gi­ta­liza­ti­on, the task was to es­tab­lish a pro­mi­sing pro­duct in co­ope­ra­ti­on with the cen­tral IT of SCHOTT AG that sup­ports the SCHOTT IT po­li­cy, but also ful­ly meets the re­qui­re­ments of the busi­ness units and cor­po­ra­te func­tions at the same time. The re­qui­re­ments can be met by the pro­duct d.3 eQMS of Di­gi­tal Life Sci­en­ces GmbH.

Qualify employees digitally — without manually maintained Excel lists

An­o­ther we­ak­ne­ss of the exis­ting do­cu­ment ma­nage­ment: A di­gi­tal Trai­ning Ma­nage­ment was miss­ing. “We didn’t have that in the old sys­tem”, de­scri­bes Stru­bel, “if the­re were new trai­nings or gui­de­lines, the re­le­vant em­ployee would just get an email with a re­fe­rence to the new gui­de­lines. In par­al­lel, we main­tai­ned Ex­cel lists and pa­per fol­ders to keep track of which col­le­ague had par­ti­ci­pa­ted in which qua­li­fi­ca­ti­on measure.”

Consolidation of six independent systems

Now good ad­vice was ex­pen­si­ve. Chris­ti­ne Stru­bel star­ted loo­king for al­ter­na­ti­ves. In Ja­nu­ary 2018, she got in clo­ser cont­act with Di­gi­tal Life Sci­en­ces GmbH, which spe­cia­li­zes in GxP-com­pli­ant do­cu­men­ta­ti­on solutions.

The so­lu­ti­on: the elec­tro­nic do­cu­ment and qua­li­ty ma­nage­ment sys­tem (d.3 eQMS) of Di­gi­tal Life Sci­en­ces GmbH. This of­fers the busi­ness units the pos­si­bi­li­ty to store and ma­na­ge do­cu­ments bey­ond silo boun­da­ries. But that’s not all.

Document control and digital workflows with dls | eQMS

Once in­stal­led and set up, the dls | eQMS al­lows for es­sen­ti­al func­tions for a com­pa­ny. The fol­lo­wing re­qui­re­ments were vi­tal for SCHOTT AG:

  • Fast search and ac­cess to di­gi­tal in­for­ma­ti­on, de­pen­ding on ro­les and work­flows, in­de­pen­dent of de­part­ments and busi­ness units
  • Ac­cep­tance by the users of the sys­tem due to ex­cel­lent usability
  • World­wi­de use and pro­vi­si­on of a sys­tem in­ter­face in mul­ti­ple languages
  • Em­ployee qua­li­fi­ca­ti­on ma­nage­ment (Trai­ning Management)
  • Ea­si­ly meet in­cre­asing do­cu­men­ta­ti­on and qua­li­ty ma­nage­ment requirements
  • Ful­ly va­li­da­ted sys­tem ac­cor­ding to com­pli­ance re­qui­re­ments such as GAMP 5, EU Di­rec­ti­ve, etc.
  • Ex­pan­si­on and ex­ten­si­on of the func­tion­a­li­ties th­rough the use of fur­ther mo­du­les, such as: 
    • Ch­an­ge Management 
    • CAPA Ma­nage­ment – Cor­rec­ti­ve And Pre­ven­ti­ve Ac­tion, a prac­ti­ce in qua­li­ty ma­nage­ment and part of GMP-com­pli­ant work (“Good Ma­nu­fac­tu­ring Practice”)
    • De­via­ti­on Control

“We were also in­te­res­ted in sa­ving cos­ts and time and in­cre­asing ef­fi­ci­en­cy”, de­scri­bes Chris­ti­ne Stru­bel: “We also wan­ted to save mo­ney by ma­na­ging do­cu­ments and sets of ru­les in a tar­ge­ted man­ner. We ma­nu­fac­tu­re pro­ducts for the me­di­cal and phar­maceu­ti­cal sec­tors, whe­re the­re are high re­qui­re­ments for do­cu­men­ta­ti­on, and the sys­tem should sup­port this. But the good pri­ce-per­for­mance ra­tio was also a de­ci­ding fac­tor. In ad­di­ti­on, a stan­dard pro­duct should be in­tro­du­ced that al­re­a­dy meets com­pli­ance re­qui­re­ments to the ext­ent that no spe­cial pro­gramming is re­qui­red, only customizing.”

First business units started in 2018 with the introduction of the new d.3 eQMS

In Sep­tem­ber 2018, two busi­ness units star­ted with dls | eQMS. SCHOTT work­ed in­ten­si­ve­ly with Di­gi­tal Life Sci­en­ces to mer­ge the va­rious do­cu­ments. The task was to avo­id du­pli­ca­tes, mo­del sui­ta­ble di­gi­tal work­flows, and de­sign ap­pro­pria­te user and aut­ho­riza­ti­on groups. More than 50,000 do­cu­ments from six dif­fer­ent­ly pa­ra­me­ter­i­zed, out­da­ted do­cu­ment ma­nage­ment sys­tems were mer­ged in this way.

The work pro­gres­sed so quick­ly that the first two units, the Ac­cre­di­ted Test La­bo­ra­to­ries of SCHOTT AG and the Light­ing and Ima­ging Busi­ness Unit, were able to go live in Ja­nu­ary 2020, less than a year and a half af­ter the pro­ject star­ted. Stru­bel: “The ex­pe­ri­ence we have had has been ex­tre­me­ly good. I would also like to high­light the va­li­da­ti­on of com­pu­ter-ba­sed sys­tems, in which Di­gi­tal Life Sci­en­ces has hel­ped us significantly.”

When mer­ging and mi­gra­ting exis­ting data into a mo­dern do­cu­ment ma­nage­ment sys­tem, not only must all par­ties in­vol­ved be able to rely on each other. It also pays to pro­ceed with tact.

Dr. Den­nis Sand­küh­ler is well awa­re of this: “We have al­ways ori­en­ted our­sel­ves to our own stan­dards when it co­mes to set­ups. We didn’t want to bend our­sel­ves or the busi­ness units, and we cer­tain­ly didn’t want to ch­an­ge the who­le organization.”

Validation of computer-based systems: “par excellence consulting” 

The ex­pe­ri­ence of Di­gi­tal Life Sci­en­ces in the phar­maceu­ti­cal and me­di­cal sec­tors be­ne­fits SCHOTT in the pro­ject: “Many of our stan­dards and re­gu­la­ti­ons, such as ISO stan­dards or re­gu­la­ti­ons for me­di­cal pro­ducts, have been reis­sued in the past year and a half”, says Chris­ti­ne Stru­bel, “and the­se ru­les of­ten in­clude the re­qui­re­ment that com­pu­ter-ba­sed sys­tems must be va­li­da­ted. This is very ex­ten­si­ve, and Di­gi­tal Life Sci­en­ces ad­vi­sed us on this par excellence.”

Two employees at work Image: ©SCHOTT

Time-saving workflows through digital document management

It the­r­e­fo­re did not take long for the other busi­ness units to fol­low suit af­ter the pi­lot pha­se. More than 3,000 em­ployees at SCHOTT sites from North Ame­ri­ca to Ma­lay­sia be­ne­fit from dls | eQMS. Chris­ti­ne Stru­bel: “We have so many new op­por­tu­ni­ties th­rough the dls | eQMS that sim­ply didn’t exist before.”

For in­s­tance:

  • Di­gi­tal work­flows with pro­files and ro­les: re­view and ap­pr­oval wi­thin pro­ces­ses. An ex­am­p­le from do­cu­ment crea­ti­on: If a re­lease pro­cess co­mes to a standstill be­cau­se one of the em­ployees who could re­lease goes on va­ca­ti­on, the pro­cess con­ti­nues at an­o­ther col­le­ague who is also al­lo­wed to re­lease — such as the de­part­ment manager.
  • De­via­ti­on ma­nage­ment and CAPA: dls | eQMS sup­ports the log­ging and cor­rec­tion of de­via­ti­ons and curr­ent­ly as­sists the Ac­cre­di­ted Test La­bo­ra­to­ries of SCHOTT AG in ful­fil­ling the re­qui­re­ments ac­cor­ding to DIN EN ISO/IEC 17025 or GMP re­qui­re­ments. Ch­an­ge pro­ces­ses, also wi­thin the d.3 eQMS, are do­cu­men­ted and re­leased with the help of Ch­an­ge Management.
  • The­re is no need any­mo­re to send Of­fice do­cu­ments back and forth by e‑mail, for ex­am­p­le, which is pro­ne to er­rors. This alo­ne in­crea­ses the qua­li­ty and ac­ce­le­ra­tes pro­ces­ses, be­cau­se thanks to dls | eQMS, SCHOTT em­ployees know that the do­cu­ments are al­ways up to date and do not have to search for the ver­si­on for a long time – thanks to the full text search func­tion, for example.
  • Em­ployee qua­li­fi­ca­ti­on ma­nage­ment (Trai­ning Ma­nage­ment): SCHOTT can now train em­ployees in any do­cu­ments just in time, with re­ceipts, di­gi­tal exams and even tests. If a new trai­ning do­cu­ment is available, the cor­re­spon­ding em­ployees re­cei­ve a mes­sa­ge from dls | eQMS with a no­ti­ce that they have to take the trai­ning or read the up­dated set of ru­les. Once this is done, em­ployees ack­now­ledge the trai­ning. The qua­li­ty assu­rance gets an over­view th­rough dls | eQMS of which em­ployee has which sta­tus and which trai­ning is in which phase.

“The Trai­ning Ma­nage­ment in par­ti­cu­lar helps us enorm­ously”, says Chris­ti­ne Stru­bel, “we didn’t have that at all be­fo­re, we had kept track of it ma­nu­al­ly in an Ex­cel file. With the many trai­ning sheets, this was a huge work, now we have a very nice over­view in the dls | eQMS. It’s also very well re­cei­ved by the staff.”

Strubel’s con­clu­si­on: “We have cho­sen the right pro­duct. Our high de­mands on usa­bi­li­ty were met, the search func­tion in dls | eQMS alo­ne is ex­cel­lent. That wasn’t bad in our pre­vious sys­tem eit­her, but it’s bet­ter now. Af­ter the trai­ning cour­ses and get­ting used to the sys­tem, it’s now much ea­sier to ma­na­ge all the do­cu­ments.” The com­bi­na­ti­on of the dif­fe­rent mo­du­les in the d.3 eQMS en­ables an ex­ten­si­on and ex­pan­si­on of the sys­tem and also of­fers fur­ther op­ti­ons for the future. 

Learn more about the training management

Get a ho­li­stic over­view of our ver­sa­ti­le Trai­ning Ma­nage­ment so­lu­ti­on now.

Illustration of a notebook on which the Training Management of Digital Life Sciences is displayed