WHO guidance on good data and record management practices

An­o­ther gui­de­line with re­fe­rence to im­ple­men­ting the le­gal re­qui­re­ments is the WHO Gui­de­line on Good Prac­ti­ce for Data and Re­cords Ma­nage­ment by the World He­alth Or­ga­niza­ti­on. This gui­de­line con­ta­ins de­tail­ed and prac­ti­cal ex­pl­ana­ti­ons on the im­ple­men­ta­ti­on and thus clo­ses exis­ting gaps in other gui­de­lines. It also ex­plains how the re­gu­la­to­ry re­qui­re­ments af­fect prac­ti­ce and what should be de­mons­tra­b­ly im­ple­men­ted to meet all requirements.

This gui­de­line espe­ci­al­ly deals with the ap­pli­ca­ti­on of data ma­nage­ment pro­ce­du­res. It is fun­da­men­tal­ly spe­ci­fied to use a sys­te­ma­tic ap­proach which gua­ran­tees that all GxP re­cords are com­pre­hen­si­ve and re­lia­ble du­ring the en­ti­re life­cy­cle. For this ef­fect, the gui­de­line re­fers to the aspects and spe­ci­fi­ca­ti­ons al­re­a­dy men­tio­ned abo­ve. Nevert­hel­ess, the chap­ter 7 of the gui­de­line deal­ing with con­trac­tors, sup­pli­ers and ser­vice pro­vi­ders, must be spe­ci­al­ly men­tio­ned. Due to the in­cre­asing trans­fer of GxP tasks, the WHO de­ems it ne­ces­sa­ry to de­fi­ne ro­les and re­spon­si­bi­li­ties and to con­sis­t­ent­ly main­tain them. The se­cu­ri­ty of the com­pre­hen­si­ve and cor­rect data and re­cords du­ring the working re­la­ti­onship must be mu­tual­ly gua­ran­teed. The re­spon­si­ble po­si­ti­ons of the con­trac­ting en­ti­ty and the con­trac­tor must com­pre­hen­si­ve­ly spe­ci­fy the pro­ces­ses to be in­tro­du­ced to en­su­re the data in­te­gri­ty. The­se de­tails should be in­cluded in a con­tract to be con­cluded for the out­sour­ced work.

If the pro­vi­si­on of da­ta­ba­ses and soft­ware is out­sour­ced, the con­trac­ting en­ti­ty must make sure that the con­trac­tors are ap­pro­ved, spe­ci­fied in the qua­li­ty agree­ment and are ade­qua­te­ly qua­li­fied and trai­ned in the GxP en­vi­ron­ment. The out­sour­ced ac­ti­vi­ties must be mo­ni­to­red re­gu­lar­ly and the con­trol­ling in­ter­vals must be spe­ci­fied as part of the risk assessment.

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 dls | eQMS 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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FDA 21 CFR Part 11 , the Ame­ri­can Food and Drug Ad­mi­nis­tra­ti­on (FDA) spe­ci­fies re­qui­re­ments for elec­tro­nic do­cu­ments, elec­tro­nic si­gna­tures and hand­writ­ten si­gna­tures ap­pli­ed to