QM software for your document & quality management » Digital LS

As an ans­wer, the Ger­man GMP re­gu­la­ti­ons, AMWHV, help us: The qua­li­ty ma­nage­ment sys­tem (QM sys­tem) is a sys­tem that in­cludes qua­li­ty assu­rance, good ma­nu­fac­tu­ring prac­ti­ce or good work prac­ti­ce, in­clu­ding qua­li­ty con­trol and pe­ri­odic pro­duct qua­li­ty re­view (PQR) (§ 2 Definitions).

§3 Qua­li­ty ma­nage­ment sys­tem, good ma­nu­fac­tu­ring prac­ti­ce and good pro­fes­sio­nal practice

Com­pa­nies and fa­ci­li­ties must im­ple­ment a com­pa­ny qua­li­ty ma­nage­ment sys­tem (QM sys­tem) that cor­re­sponds to the type and scope of the ac­ti­vi­ties per­for­med. The QM sys­tem shall in­clude good ma­nu­fac­tu­ring prac­ti­ce in the ca­ses re­fer­red to in pa­ra­graph 2 and good pro­fes­sio­nal prac­ti­ce in the ca­ses re­fer­red to in pa­ra­graph 3, and shall pro­vi­de for the ac­ti­ve par­ti­ci­pa­ti­on of the ma­nage­ment of the es­tab­lish­ments and fa­ci­li­ties and of the per­son­nel of the va­rious sec­tors con­cer­ned. All are­as in­vol­ved in es­tab­li­shing, main­tai­ning and im­ple­men­ting the qua­li­ty ma­nage­ment sys­tem must have com­pe­tent per­son­nel and sui­ta­ble and suf­fi­ci­ent pre­mi­ses and equip­ment. The qua­li­ty ma­nage­ment sys­tem must be ful­ly do­cu­men­ted and its pro­per func­tio­ning de­mons­tra­ted (§ 1).

Cer­ti­fied com­pa­nies have long been the norm in ma­nu­fac­tu­ring and in­dus­tries with many pro­duc­tion steps. Ho­we­ver, it is also a fact that it’s in­cre­asing­ly used in the ser­vice sec­tor. Ma­na­gers have un­ders­tood that pro­cess and “pro­duct” qua­li­ty are also me­thods in this area to dif­fe­ren­tia­te their own pro­duct from that of the com­pe­ti­ti­on. Fur­ther­mo­re, pro­cess qua­li­ty is an ef­fec­ti­ve way to avo­id the cost of er­rors. That is why more and more com­pa­nies in the ser­vice sec­tor are re­ly­ing on the DIN EN ISO 9001 qua­li­ty ma­nage­ment stan­dard. The more spe­ci­fic the in­dus­try, the more spe­ci­fic the stan­dard. For ex­am­p­le, la­bo­ra­to­ries have an ISO 17025 sys­tem, the au­to­mo­ti­ve in­dus­try has the IATF 16949 stan­dard, and me­di­cal de­vice ma­nu­fac­tu­r­ers have the ISO 13485 stan­dard. The­se ex­em­pla­ry stan­dards are all de­ri­ved from ISO 9001. Ho­we­ver, due to their re­spec­ti­ve fields, they of­ten have more ex­ten­si­ve re­qui­re­ments and more spe­ci­fic bases.

A qua­li­ty ma­nage­ment sys­tem (QMS) has many ad­van­ta­ges. It can lead to cost sa­vings and fa­ci­li­ta­te mar­ket ac­cess. A qua­li­ty ma­nage­ment sys­tem helps com­pa­nies in the fol­lo­wing es­sen­ti­al aspects:

• Im­pro­ved mar­ket ac­cess: In a glo­ba­li­zed mar­ket en­vi­ron­ment, a com­pa­ny with a cer­ti­fied QMS can de­mons­tra­te that qua­li­ty and pro­cess safe­ty are sys­te­ma­ti­cal­ly ad­dres­sed. In some in­dus­tries, such as the au­to­mo­ti­ve in­dus­try, such a cer­ti­fi­ca­te is a man­da­to­ry re­qui­re­ment for busi­ness transactions.
• Bet­ter qua­li­ty at lower cost: Qua­li­ty ma­nage­ment en­su­res qua­li­ty as ear­ly as pos­si­ble in the de­ve­lo­p­ment pro­cess. Ear­ly de­tec­tion of de­fects is much more cost ef­fec­ti­ve com­pared to de­tec­tion du­ring fi­nal inspection.
• Cost sa­vings: The com­pa­ny sa­ves mo­ney by pro­du­cing less was­te. This re­du­ces the cost of purcha­sing raw ma­te­ri­als and dis­po­sing of waste.
• Sys­te­ma­tic qua­li­ty thin­king among em­ployees: A QMS al­lows all em­ployees of a com­pa­ny (not only the qua­li­ty assu­rance ex­perts) to be in­vol­ved in qua­li­ty assurance.
• Trans­pa­rent busi­ness pro­ces­ses: Ope­ra­tio­nal pro­ces­ses are do­cu­men­ted and de­scri­bed. This makes them trans­pa­rent and ea­sier to re­view for im­pro­ve­ment op­por­tu­ni­ties. It also makes it ea­sier to iden­ti­fy and eli­mi­na­te problems.
• Sus­tainable stan­dard: Qua­li­ty ma­nage­ment sys­tems help to se­cu­re the achie­ved op­ti­miza­ti­ons in the long term by ma­king the im­pro­ved pro­ce­du­res and pro­ces­ses “stan­dard prac­ti­ce” and thus the norm.
• Bet­ter know-how trans­fer: Do­cu­men­ted and de­scri­bed work­flows and pro­ces­ses enable a more ef­fi­ci­ent and ef­fec­ti­ve trans­fer of ope­ra­tio­nal know-how. This makes it ea­sier to train new em­ployees, for example.

QM soft­ware (qua­li­ty ma­nage­ment soft­ware) au­to­ma­tes the pro­cess of track­ing and mi­ni­mi­zing pro­duct de­via­ti­ons. Com­pa­nies use the­se ap­pli­ca­ti­ons to mo­ni­tor and con­trol pro­duct qua­li­ty. By coll­ec­ting and ana­ly­zing data, com­pa­nies can iden­ti­fy, iso­la­te and cor­rect un­fo­re­seen pro­duct de­fects or other pro­blems that may oc­cur du­ring pro­duc­tion. In ad­di­ti­on, our QM soft­ware sup­ports you in ta­king into ac­count the re­le­vant laws, gui­de­lines as well as stan­dards in the con­trol­led en­vi­ron­ment, such as ISO 15189, 17025, 9001, 14001, 16949, FDA 21 CFR Part 11, MPG, ISO 13485, MDR 2017/745, and many more.

With the QM soft­ware from Di­gi­tal Life Sci­en­ces, you re­cei­ve a sys­tem at the hig­hest le­vel re­ly­ing on the ex­cel­lent pro­cess know­ledge and ex­per­ti­se of the team. You get soft­ware that is open for the in­te­gra­ti­on of other IT sys­tems, such as LIMS/ERP. Due to the con­ti­nuous fur­ther de­ve­lo­p­ment as stan­dard soft­ware, you are per­fect­ly pre­pared with re­gard to the va­li­da­ti­on of the soft­ware and fur­ther­mo­re re­main fle­xi­ble with re­gard to your cus­to­miza­ti­on wis­hes due to in­di­vi­du­al con­fi­gu­ra­ti­on op­ti­ons. Mo­reo­ver, our so­lu­ti­ons can be un­ders­tood as a mo­du­lar buil­ding block sys­tem, whe­re you can suc­ces­si­ve­ly ex­pand your system.

With the qua­li­ty ma­nage­ment soft­ware from Di­gi­tal Life Sciences…

• you ma­na­ge your de­fault do­cu­ments (e.g. work and pro­cess in­s­truc­tions, test spe­ci­fi­ca­ti­ons, hy­gie­ne plans), forms, con­tracts and other do­cu­ment ty­pes digitally
• you take care of do­cu­ment dis­tri­bu­ti­on and si­gna­tu­re cir­cu­la­ti­on di­gi­tal­ly at the touch of a but­ton and fo­cus on your core business
• you pro­tect your data from un­wan­ted ac­tions of un­aut­ho­ri­zed users
• save time by mi­ni­mi­zing pro­cess run­times for crea­ting, re­vi­sing, re­leasing, and dis­tri­bu­ting your de­fault documents
• you re­du­ce un­neces­sa­ry prin­touts and pa­per on your desk. This spa­res the en­vi­ron­ment, your ner­ves and your money.

Our pro­ducts were laun­ched and va­li­da­ted suc­cessful­ly in num­e­rous phar­maceu­ti­cal com­pa­nies. Li­ke­wi­se, our pro­ducts have been suc­cessful­ly au­di­ted du­ring TÜV au­dits in ac­cordance with the gui­de­lines of ISO stan­dards 9001 and 13485 and du­ring in­spec­tions by the Re­gio­nal Coun­cil (Ger­ma­ny).

As a soft­ware pro­vi­der for com­pa­nies in the GxP en­vi­ron­ment, con­duc­ting sup­pli­er au­dits is com­mon prac­ti­ce. In re­cent ye­ars, we have al­re­a­dy been au­di­ted many times in on-site au­dits or pos­tal au­dits by our cus­to­mers and in­te­res­ted par­ties, e.g. in ac­cordance with the re­qui­re­ments of GAMP5.