SUPPLIER QUALIFICATION SOFTWARE

Software for your effective supplier qualification 

Qua­li­fy­ing your sup­pli­ers mi­ni­mi­ses the risk from out­sour­cing ser­vices and en­su­res the qua­li­ty of your pro­ducts, even in in­ter­na­tio­nal sup­p­ly chains.

Al­ways up-to-date in­for­ma­ti­on about the sta­tus of your suppliers 

Com­pli­ance with your spe­ci­fic regulations 

Ef­fi­ci­en­cy and trans­pa­ren­cy th­rough di­gi­tal processes 

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» en­g­amp® | sup­pli­er qualification «

Software for the effective qualification of your suppliers

Our soft­ware “en­g­amp® | sup­pli­er qua­li­fi­ca­ti­on” ef­fec­tively op­ti­mi­ses the sup­pli­er qua­li­fi­ca­ti­on pro­cess by do­cu­men­ting risk-ba­sed pro­ce­du­res and pro­vi­ding a con­stant­ly up­dated over­view of the sta­tus of your sup­pli­ers. This cen­tral source of in­for­ma­ti­on al­lows you to re­act quick­ly to ch­an­ges and en­su­re com­pli­ance with qua­li­ty stan­dards, ul­ti­m­ate­ly gua­ran­te­e­ing the qua­li­ty of your end products.

By au­to­ma­ting the qua­li­fi­ca­ti­on pro­cess, the sup­pli­er qua­li­fi­ca­ti­on soft­ware si­gni­fi­cant­ly re­du­ces the ad­mi­nis­tra­ti­ve workload. It en­ables you to op­ti­mi­se the plan­ning and im­ple­men­ta­ti­on of au­dits, mo­ni­tor the va­li­di­ty of cer­ti­fi­ca­tes and en­su­re that all sup­pli­ers meet the ne­ces­sa­ry re­qui­re­ments. This in­crea­ses your company’s ef­fi­ci­en­cy by sa­ving time and re­sour­ces while mi­ni­mi­sing the risk of qua­li­ty de­fects.

Abbildung eines Screenshots auf dem die Software Lieferantenqualifizierung der Digital Life Sciences abgebildet wird

What benefits does the supplier qualification software offer?

‘Single point of truth’ regarding the status of your suppliers 

Sup­pli­er qua­li­fi­ca­ti­on ser­ves as an es­sen­ti­al source of in­for­ma­ti­on for trans­par­ent­ly and re­lia­bly de­ter­mi­ning the sta­tus of sup­pli­ers from whom ser­vices and ma­te­ri­als may be procured. 

Representation of the supply chain based on material numbers 

The vi­su­al re­pre­sen­ta­ti­on of the sup­p­ly chain from ma­te­ri­als to the end pro­duct crea­tes grea­ter trans­pa­ren­cy for stake­hol­ders and en­ables a dif­fe­ren­tia­ted view by tar­get country. 

Risk-based definition of qualification measures 

De­fi­ning the re­qui­red do­cu­ments ba­sed on your risk eva­lua­ti­on en­su­res com­pli­ance with re­gu­la­to­ry re­qui­re­ments and avo­ids miss­ing proofs. 

Efficient planning and implementation of audits 

In­te­gra­ted tools for op­ti­mi­sed plan­ning and im­ple­men­ta­ti­on of au­dits save time and re­sour­ces and in­crease the over­all ef­fi­ci­en­cy of qua­li­ty con­trol processes. 

Document dossier per qualification 

A spe­ci­fic dos­sier with do­cu­ments for each qua­li­fi­ca­ti­on do­cu­ments the cur­rent sta­tus and en­ables di­rect ac­cess to pro­ofs, cer­ti­fi­ca­tes, contracts… 

Documented release process 

The GMP-com­pli­ant do­cu­men­ta­ti­on of all re­le­vant ac­tions in the au­dit trail pro­vi­des the per­son re­spon­si­ble for the re­lease with a re­lia­ble ba­sis for decision-making. 

Monitoring of certificates and qualifications 

Au­to­ma­tic mo­ni­to­ring and no­ti­fi­ca­ti­on of the va­li­di­ty of cer­ti­fi­ca­tes keep the cer­ti­fi­ca­ti­on sta­tus up to date, pre­vent in­ter­rup­ti­ons in the sup­p­ly chain due to ex­pi­red cer­ti­fi­ca­tes and help main­tai­ning high-qua­li­ty standards. 

Templates for questionnaires, audit reports and evaluations 

Pre­de­fi­ned tem­pla­tes for dif­fe­rent eva­lua­ti­on pro­ces­ses stan­dar­di­se data coll­ec­tion and re­port­ing, fa­ci­li­ta­te au­dit pre­pa­ra­ti­on and con­duc­ting and in­crease efficiency. 

Digitise your processes for greater efficiency

We would like to present you some features already

Abbildung eines Screenshots auf dem die Software Lieferantenqualifizierung der Digital Life Sciences abgebildet wird
List view

The list view of qua­li­fi­ca­ti­ons acts as a ‘sin­gle point of truth’ for the cur­rent sta­tus of your sup­pli­ers. Using quick fil­ters for a risk class or sta­tus, you can search for spe­ci­fic sup­pli­ers, sup­pli­er ty­pes or ma­te­ri­al numbers.

Risk class

The me­a­su­res re­qui­red to qua­li­fy a sup­pli­er type are de­ter­mi­ned and the va­li­di­ty pe­ri­od of the qua­li­fi­ca­ti­on is cal­cu­la­ted ta­king into ac­count the risk class.

Do­cu­ments

The qua­li­fi­ca­ti­on do­cu­ments are di­rect­ly ac­ces­si­ble as a dos­sier. The de­scrip­ti­ve me­ta­da­ta con­ti­nuous­ly mo­ni­tors the va­li­di­ty of the stored cer­ti­fi­ca­tes and other proofs.

Sup­p­ly chain

By as­sig­ning ma­te­ri­al num­bers, pro­ducts and tar­get count­ries, you gain a com­pre­hen­si­ve in­sight into a product’s sup­p­ly chain.

Would you like a live insight into the software?

Get a live in­sight into the pos­si­bi­li­ties of qua­li­fy­ing sup­pli­ers in just 45 mi­nu­tes ba­sed on a sam­ple use case. Find out how you can use Di­gi­tal Life Sci­en­ces so­lu­ti­ons to ob­tain up-to-date in­for­ma­ti­on on the sta­tus of your suppliers.

Some features of supplier qualification

The following regulations were taken into account in the supplier qualification software

GMP Gui­de­line Chap­ter 1 & 5 

MDR 2017/745 Ar­tic­le 10 (9) d 

FDA 21 CFR 820.50

Or­di­nan­ce for the Ma­nu­fac­tu­re of Me­di­cinal Pro­ducts and Ac­ti­ve Phar­maceu­ti­cal In­gre­di­ents (AMWHV) § 11 

ICH Q10 2.7

33 Good reasons for a cooperation with Digital LS

You’re not con­vin­ced yet? You’re not con­vin­ced yet? Find out about 33 good re­asons spea­king for a co­ope­ra­ti­on with Di­gi­tal Life Sci­en­ces GmbH. We will show you re­asons from the provider’s point of view, from the soft­ware point of view and other ge­ne­ral re­asons that di­stin­gu­ish us.

Customer opinion on supplier qualification

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Frequently asked questions (FAQs) about supplier qualification

Sup­pli­er qua­li­fi­ca­ti­on is the pro­cess of eva­lua­ting and sel­ec­ting sup­pli­ers to en­su­re that they meet the company’s qua­li­ty and com­pli­ance re­qui­re­ments. This pro­cess in­vol­ves se­ve­ral steps, in­clu­ding risk eva­lua­ti­on, con­duc­ting au­dits, re­vie­w­ing re­gu­la­to­ry com­pli­ance and re­gu­lar­ly mo­ni­to­ring the supplier’s per­for­mance. The goal is to gua­ran­tee the in­te­gri­ty of the sup­p­ly chain and en­su­re that ma­te­ri­als and ser­vices meet the spe­ci­fied qua­li­ty standards.

Sup­pli­er qua­li­fi­ca­ti­on is an es­sen­ti­al part of qua­li­ty ma­nage­ment, espe­ci­al­ly in high­ly re­gu­la­ted sec­tors such as the life sci­ence in­dus­try. It en­su­res that all sup­pli­ers com­ply with the re­qui­red stan­dards and le­gal re­gu­la­ti­ons. The sup­pli­er qua­li­fi­ca­ti­on pro­cess can be de­scri­bed as follows:

1. Needs ana­ly­sis and re­cor­ding of requirements:

  • De­fi­ni­ti­on of the type and qua­li­ty of raw ma­te­ri­als and pack­a­ging ma­te­ri­als, ta­king into ac­count the fi­nis­hed products.
  • In the case of pro­cu­re­ment via in­ter­me­dia­ries, re­spon­si­bi­li­ties must be de­fi­ned and the source of sup­p­ly identified.

2. Sup­pli­er selection:

  • Re­se­arch and com­pi­la­ti­on of po­ten­ti­al suppliers.
  • Pre-sel­ec­tion ba­sed on cri­te­ria such as pro­duct qua­li­ty, pri­ce, de­li­very re­lia­bi­li­ty and com­pli­ance with re­le­vant regulations.

3. Risk evaluation:

  • Risk clas­ses are as­si­gned to sup­pli­ers and ser­vice pro­vi­ders, pos­si­bly sup­ple­men­ted by a more de­tail­ed clas­si­fi­ca­ti­on using a risk prio­ri­ty number.
    The ne­ces­sa­ry GMP re­qui­re­ments are then defined.

4. Qua­li­fi­ca­ti­on:

Risk mi­ni­mi­sa­ti­on me­a­su­res are de­fi­ned for each iden­ti­fied risk:

  • Re­quest and eva­lua­ti­on of ques­ti­on­n­aires and self-dis­clo­sure forms to cla­ri­fy im­portant information.
  • Cla­ri­fi­ca­ti­on of am­bi­gui­ties with the sup­pli­er and do­cu­men­ta­ti­on for the qua­li­fied per­son for the over­all evaluation.
  • Sto­rage of cer­ti­fi­ca­tes, re­fe­ren­ces and tes­ti­mo­ni­al from other phar­maceu­ti­cal manufacturers.
  • Ma­te­ri­al qua­li­fi­ca­ti­on ba­sed on ma­nu­fac­tu­rer bat­ches, which are che­cked for con­for­mi­ty with cer­ti­fi­ca­ti­ons and specifications.
  • Qua­li­ty agree­ment in which cen­tral aspects such as GMP stan­dard, storage/transport, hand­ling of de­via­ti­ons are addressed.
  • On-site au­dits with do­cu­men­ted pro­of of the me­a­su­res de­fi­ned in the au­dit report.

The avai­la­bi­li­ty of an up-to-date list of ap­pro­ved ma­nu­fac­tu­r­ers and sup­pli­ers must be en­su­red so that or­ders can only be pla­ced with ap­pro­ved sup­pli­ers and manufacturers.

5. De­li­very

  • Do­cu­men­ta­ti­on of ana­ly­sis data and rejections.
  • Sys­te­ma­tic mo­ni­to­ring of of­fi­ci­al in­spec­tion results.

6. Re­qua­li­fi­ca­ti­on:

  • Re­ne­wed im­ple­men­ta­ti­on of the qua­li­fi­ca­ti­on me­a­su­res in ac­cordance with the re­qui­re­ments of the risk ma­nage­ment system.

7. Eva­lua­ti­on of changes:

  • Ch­an­ges on the part of the sup­pli­er are eva­lua­ted in re­la­ti­on to the risk as part of the do­cu­men­ted ch­an­ge con­trol procedure.

The struc­tu­red and me­tho­di­cal im­ple­men­ta­ti­on of sup­pli­er qua­li­fi­ca­ti­on en­su­res that all ne­ces­sa­ry qua­li­fi­ca­ti­ons are met, the qua­li­ty of the ma­te­ri­als or ser­vices to be sup­pli­ed is assu­red and re­gu­la­to­ry re­qui­re­ments are strict­ly ad­he­red to. This pro­mo­tes ef­fi­ci­en­cy, trans­pa­ren­cy and com­pli­ance wi­thin the sup­p­ly chain.

Ch­an­ges at the sup­pli­er or ex­piry of the va­li­di­ty of a qua­li­fi­ca­ti­on re­qui­re re-qua­li­fi­ca­ti­on. A new ver­si­on of the qua­li­fi­ca­ti­on is crea­ted and the re­le­vant data is trans­fer­red. The qua­li­fi­ca­ti­on pro­cess is then car­ri­ed out again.

The va­li­di­ty date of a qua­li­fi­ca­ti­on is cal­cu­la­ted ba­sed on the de­fi­ned in­ter­val for the risk class.

A com­pre­hen­si­ve sup­pli­er eva­lua­ti­on in the con­text of GDP (Good Dis­tri­bu­ti­on Prac­ti­ce) and GMP (Good Ma­nu­fac­tu­ring Prac­ti­ce) in­cludes a sys­te­ma­tic re­view of the supplier’s com­pli­ance with the­se re­gu­la­to­ry re­qui­re­ments. This in­cludes coll­ec­ting and ana­ly­sing re­le­vant data to en­su­re that the sup­pli­er meets all ne­ces­sa­ry qua­li­ty stan­dards. Re­gu­lar au­dits and the ana­ly­sis of coll­ec­ted in­for­ma­ti­on en­su­re con­ti­nuous sup­pli­er de­ve­lo­p­ment and qua­li­ty assurance.

Data and in­for­ma­ti­on are of cen­tral im­portance in en­su­ring com­pli­ance in sup­pli­er qua­li­fi­ca­ti­on. Com­pli­ance with GDP and GMP gui­de­lines is che­cked th­rough the sys­te­ma­tic coll­ec­tion and ana­ly­sis of per­for­mance data. This in­for­ma­ti­on ser­ves as a ba­sis for the eva­lua­ti­on of sup­pli­ers and en­ables well-foun­ded de­cis­i­ons for the con­ti­nuous im­pro­ve­ment of sup­pli­er de­ve­lo­p­ment. Pre­cise data usa­ge helps to main­tain the hig­hest qua­li­ty stan­dards and en­su­re compliance.

In ad­di­ti­on to the con­fi­gu­red sup­pli­er ty­pes in the ap­pli­ca­ti­on, the in­di­vi­du­al ma­te­ri­al num­bers can also be as­si­gned to the qua­li­fi­ca­ti­on of a supplier.

In en­g­amp | sup­pli­er qua­li­fi­ca­ti­on, ma­te­ri­al num­bers, end pro­ducts and lo­ca­ti­ons can be as­si­gned to a qua­li­fi­ca­ti­on to en­su­re a trans­pa­rent sup­p­ly chain.

The do­cu­ment dos­sier of a qua­li­fi­ca­ti­on is an es­sen­ti­al part of en­g­amp | sup­pli­er qua­li­fi­ca­ti­on. De­pen­ding on the risk class, a check­list is crea­ted with the ne­ces­sa­ry do­cu­ments that must be re­ques­ted, crea­ted and controlled.

It will be pos­si­ble to plan au­dits from a qua­li­fi­ca­ti­on. In ad­di­ti­on to self-con­duc­ted au­dits with sche­du­ling and sel­ec­tion of the au­dit team, third-par­ty au­dits and writ­ten au­dits can also be planned.

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