GMP stands for “Good Ma­nu­fac­tu­ring Prac­ti­ce” or Ger­man “Gute Her­stell­pra­xis”. Thus, GMP con­ta­ins po­li­ci­es and re­gu­la­ti­ons that al­ways have to be ob­ser­ved, if or­ga­niza­ti­ons deal with the pro­duc­tion and hand­ling of pro­ducts which may af­fect hu­mans’ qua­li­ty of life. Among them are me­di­cinal pro­ducts and food but also cos­me­tics. Sin­ce qua­li­ty de­via­ti­ons can have im­me­dia­te ef­fects on the hu­man he­alth, qua­li­ty assu­rance plays a cen­tral role espe­ci­al­ly in phar­maceu­ti­cal pro­duc­tion. Thus, or­ga­niza­ti­ons in this sec­tor are ob­li­ged to in­tro­du­ce a GMP-com­pli­ant qua­li­ty ma­nage­ment sys­tem to gua­ran­tee the re­qui­red pro­duct qua­li­ty and to com­ply with le­gal re­qui­re­ments for the mar­ke­ting of their system.

A GMP-com­pli­ant qua­li­ty ma­nage­ment con­sist of se­ve­ral ele­ments such as the do­cu­ment ma­nage­ment for spe­ci­fi­ca­ti­on do­cu­ments to name but one. Re­qui­re­ments in­clude that the spe­ci­fi­ca­ti­on do­cu­ments such as work in­s­truc­tions, pro­cess in­s­truc­tions, form sheets etc. must be ver­si­on-con­trol­led and sub­ject to a de­fi­ned life­cy­cle. Mo­reo­ver, the­se do­cu­ments must have an au­dit trail in which all ac­tions, espe­ci­al­ly ch­an­ges, are to be log­ged. Wi­t­hout com­pli­ance to the GMP re­gu­la­ti­ons, no or­ga­niza­ti­on gets the ap­pr­oval to pro­du­ce phar­maceu­ti­cal products.

Your path to digitization — Discover our software

Our di­gi­ta­liza­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the d.3 life sci­en­ces sys­tem is an in­te­gra­ted ECM/DMS sys­tem. The ECM/DMS sys­tem can be lin­ked to your exis­ting ERP sys­tem (e.g. SAP), thus en­ab­ling you to im­ple­ment al­most all do­cu­ment-ba­sed pro­ces­ses in your company.

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Complaint management

De­fi­ni­ti­on of the term („What is a com­plaint?“)  A com­plaint ma­nage­ment in­cludes all me­a­su­res ta­ken by a com­pa­ny to pro­cess cus­to­mer com­plaints about the company’s