Representation of the Pflüger logo

Homöopathisches Laboratorium Alexander Pflüger GmbH design digital processes themselves

„Ye­ars ago, we used to track the sta­tus of do­cu­ments such as work in­st­ruc­tions, em­ployee qua­li­fi­ca­ti­on re­cords and batch re­ports using an Ac­cess da­ta­ba­se or on pa­per. Howe­ver, it was te­dious to keep the do­cu­ments up to date and to ma­na­ge them in an au­dit-com­pli­ant man­ner. In 2012, we swit­ched to the di­gi­tal do­cu­ment ma­nage­ment of d.velop Life Sci­en­ces, which was a quan­tum leap. To­day we can crea­te, find, edit and coor­di­na­te do­cu­ments much fas­ter. This saves working time and costs.“

Björn Boxhammer - Leitung Qualitätssicherung & IT - Homöopathisches Laboratorium Alexander Pflüger GmbH & Co. KG
Björn Box­ham­mer
Head of IT and Qua­li­ty As­suran­ce at Pflü­ger GmbH (Ho­möo­pa­thi­sches La­bo­ra­to­ri­um Alex­an­der Pflü­ger GmbH)

Strict re­gu­la­ti­ons from the HAB (Ger­man: ‘Ho­möo­pa­thi­sches Arz­nei­buch’, Ho­me­o­pa­thic Phar­ma­co­poeia) ap­p­ly to the pro­duc­tion of ho­me­o­pa­thic me­di­ci­nes. The­re­fo­re, the ap­pro­xi­mate­ly 130 em­ployees of Pflü­ger GmbH in Rhe­da-Wie­den­brück in North Rhi­ne-West­pha­lia pay me­ti­cu­lous at­ten­ti­on to the va­rious work in­st­ruc­tions and pro­cess ma­nu­als du­ring pro­duc­tion. A lar­ge num­ber of work steps are pre­scri­bed for the ap­pro­xi­mate­ly 350 me­di­ci­nes that Pflü­ger has in its range.

The GmbH re­li­es on seam­less qua­li­ty as­suran­ce (QA). A pletho­ra of QA do­cu­ments must the­re­fo­re be crea­ted, pe­rio­di­cal­ly mo­ni­to­red and pas­sed on to the re­spec­ti­ve em­ployees for trai­ning. Ye­ars ago, Pflü­ger em­ployees used a hy­brid so­lu­ti­on of Ac­cess da­ta­ba­se and pa­per-ba­sed pro­ces­ses, for ex­amp­le, to keep track of who had al­rea­dy re­cei­ved which instruction.

“At that time, each de­part­ment had its own pa­per file,” de­scri­bes Björn Box­ham­mer, Head of IT and Qua­li­ty As­suran­ce at Pflü­ger GmbH, “and we in Qua­li­ty As­suran­ce had to ex­chan­ge the re­le­vant do­cu­ments by hand when the­re were new ver­si­ons. Mo­reo­ver, we had to keep track of when the do­cu­ment was read.”

Ye­ars ago, such ma­nu­al tracking and or­ga­niz­a­ti­on may have been fea­si­ble. Howe­ver, many pro­ce­du­res, pro­ces­ses and gui­de­li­nes have now be­co­me more com­plex and spe­ci­fic. “That’s whe­re soft­ware hel­ps to keep track,” Box­ham­mer sums up. Af­ter the con­sist­ent­ly good ex­pe­ri­en­ces in the pro­cess of the ar­chi­ving so­lu­ti­on for qua­li­ty-re­le­vant do­cu­ments, Pflü­ger GmbH swit­ched to the new­ly es­tab­lis­hed Life Sci­ence Cli­ent of d.velop Life Sciences.

Illustration of a gentleman holding a product of Homöopathisches Laboratorium Alexander Pflüger GmbH & Co. KG in the hand

Get signatures for QA documents faster

“Espe­cial­ly for the ma­nage­ment and trai­ning of QA re­le­vant do­cu­ments, a pa­per-ba­sed pro­cess is a lot of work,” says Frank Lau­mann, Head of Ser­vices at d.velop Life Sci­en­ces. “A qua­li­ty ma­nage­ment ma­nu­al with all its pro­ce­du­res, work in­st­ruc­tions and forms must be si­gned by several peop­le. A di­gi­tal pro­cess has an ac­ce­le­ra­ting ef­fect here, espe­cial­ly if the do­cu­ments are to be made ac­ces­si­ble to many employees.”

One fo­cus of d.velop Life Sci­en­ces is on soft­ware and ser­vices for com­pa­nies in the phar­maceu­ti­cal en­vi­ron­ment. “Among other things, the re­le­vant know-how was cru­cial for us,” says Box­ham­mer, “and the sen­se of pro­por­ti­on with which Life Sci­en­ces ap­proa­ched the pro­ces­ses. That me­ant a high de­gree of cer­tain­ty for us.”

As a ba­sis for di­gi­tal do­cu­ment con­trol, d.velop Life Sci­en­ces uses the do­cu­ment ma­nage­ment sys­tem d.velop do­cu­ments (form­er­ly d.3ecm). The soft­ware is power­ful: Over the ye­ars, Pflü­ger GmbH has ac­cu­mu­la­ted al­most two mil­li­on do­cu­ments in the sys­tem, both GxP-re­le­vant do­cu­ments such as pro­cess and work in­st­ruc­tions and pro­of of em­ployee qua­li­fi­ca­ti­ons, batch re­ports, ac­ti­ve in­gre­dient do­cu­men­ta­ti­on, but also com­mer­cial do­cu­ments such as con­tracts, e‑mails, in­voices and many more.

Design digital processes yourself

The sys­tem now di­gi­tal­ly im­ple­ments many pro­ces­ses so that no qua­li­ty as­suran­ce em­ployee has to ma­nu­al­ly up­date do­cu­ments in va­rious fol­ders. An ex­amp­le: Pre­pa­ra­ti­on of do­cu­ments such as pro­ce­du­ral in­st­ruc­tions or man­da­to­ry phar­maceu­ti­cal texts, but also mar­ke­ting texts for the print sec­tor. “This can be done won­der­ful­ly with the sys­tem,” says Björn Box­ham­mer, “em­ployees en­ter their draft texts cen­tral­ly and are for­war­ded to col­leagues for re­view and ap­pro­val using work­flow. Thanks to di­gi­tal do­cu­ment con­trol, ever­yo­ne al­ways works on the same, con­stant­ly up-to-date version.”

Among others, Pflü­ger GmbH has me­an­while im­ple­men­ted the­se pro­ces­ses with the di­gi­tal do­cu­ment con­trol of d.velop Life Sciences:

  • Con­tract Management
  • In­co­m­ing in­voice pro­ces­sing with ap­pro­val process
  • Con­ti­nuous up­dating and pro­vi­si­on of qua­li­ty ma­nage­ment do­cu­ments, pro­ce­du­ral in­st­ruc­tions, such as MOP (Mas­ter Ope­ra­ting Pro­ce­du­re) and SOP do­cu­ments (Stan­dard Ope­ra­ting Procedure)
  • Or­ga­niz­a­ti­on of pa­ck­a­ging de­signs for fol­ding bo­xes, la­bels and inserts
  • Va­rious mar­ke­ting pro­ces­ses with ap­pro­val of print tem­pla­tes and ad­ver­ti­sing material
  • Ma­nage­ment of man­da­to­ry phar­maceu­ti­cal texts
  • Ar­chi­ving of ma­nu­fac­tu­ring do­cu­men­ta­ti­on and sa­les documents
  • E‑mail ar­chi­ving

The do­cu­ment con­trol pro­cess is roun­ded off with the ful­ly in­te­gra­ted Em­ployee Qua­li­fi­ca­ti­on Ma­nage­ment (EQM) mo­du­le. This mo­du­le con­trols which up­dated do­cu­ments have al­rea­dy been read by which em­ployees: if, for ex­amp­le, the­re is a new work in­st­ruc­tion, the sys­tem au­to­ma­ti­cal­ly sends a read and un­ders­tood trai­ning to the em­ployees con­cer­ned and pla­ces it in the employee’s task mail­box.

Automatic reminder of expiring deadlines and other benefits

For con­tracts, Dead­line Ma­nage­ment from the Con­tract Ma­nage­ment mo­du­le au­to­ma­ti­cal­ly re­minds you when dead­lines are about to ex­pi­re. “This not only saves me working time, but also any ad­di­tio­nal cos­ts that may be in­cur­red, in the event of mis­sed no­ti­ce pe­ri­ods,” says Box­ham­mer. The sys­tem dis­plays fol­der links and as­so­cia­ted do­cu­ments so that, for ex­amp­le, in­voices, con­tracts or com­p­laints for a sup­plier are dis­play­ed in an over­view. Em­ployees can find do­cu­ments with the full-text se­arch func­tion and a few se­arch terms, just as if they were using an In­ter­net se­arch engine.

One of the la­test im­ple­men­ted pro­jects with exis­ting soft­ware is di­gi­tal in­co­m­ing in­voice ve­ri­fi­ca­ti­on. Ori­gi­nal­ly, most in­voices were re­cei­ved as pa­per, but la­ter more and more were also re­cei­ved as PDFs. Em­ployees prin­ted the PDFs, ap­p­lied the ac­count as­sign­ment stamp to each in­voice, and scan­ned the in­voices back in with ex­pan­ded in­for­ma­ti­on. This made for some sources of er­ror, but most im­port­ant­ly, the pa­per in­voices were stuck too long in the ve­ri­fi­ca­ti­on cy­cle that was dis­tri­bu­t­ed through the in-house mail.

Digital incoming invoice automatically recognizes data

Af­ter im­ple­men­ting the di­gi­tal in­co­m­ing in­voice, the sys­tem now au­to­ma­ti­cal­ly re­co­gni­zes in­co­m­ing in­voices and di­gi­tal­ly re­cords in­for­ma­ti­on such as sup­plier, in­voice num­ber, to­tal amount and in­voice date. Af­ter re­co­gni­ti­on, the in­voices run through the work­flow for fac­tu­al ve­ri­fi­ca­ti­on and ent­ry of item data. If in­for­ma­ti­on is in­con­clu­si­ve or con­tra­dic­to­ry, the sys­tem in­di­ca­tes this to a re­spon­si­ble per­son. The sys­tem then sends the in­voice on for ap­pro­val and, in the fi­nal work­flow step, to fi­nan­cial ac­coun­ting for re­lease. “This puts an end to ti­re­so­me en­qui­ries about which cost cen­ter or which G/L ac­count an in­voice has to be pos­ted to,” says Box­ham­mer. Pro­vi­ded that ever­ything is in or­der, all re­cor­ded data is trans­fer­red to the da­ta­ba­se of the IGF ac­coun­ting sys­tem con­nec­ted via interface.

Fur­ther­mo­re, do­cu­ment con­trol al­lows the em­ployees of Pflü­ger GmbH to crea­te, chan­ge and de­sign di­gi­tal pro­ces­ses them­sel­ves. Box­ham­mer: “With d.velop do­cu­ments (form­er­ly d.3ecm) we have a plat­form for many en­tre­pre­neu­ri­al is­su­es, which all grow out of qua­li­ty thin­king. The d.velop Life Sci­en­ces pro­mi­ses not­hing that is not also kept. To­day we can crea­te, find, edit and coor­di­na­te do­cu­ments much fas­ter. This saves working time and cos­ts.” I wouldn’t want to miss this any­mo­re, it’s re­al­ly very good.”

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Solution overview of d.velop Life Sciences with process documentation, contract management, technical documentation, deviation control, CAPA, change control, complaint, document control, employee qualification management, e-learning