DLS at the GAMP®5 Conference 2024: Central GAMP topics at a glance

DLS at the GAMP®5 Conference 2024: Central GAMP topics at a glance

Di­gi­tal Life Sci­en­ces took part in the GAMP®5 Con­fe­rence in Mann­heim from De­cem­ber 3 to 5, 2024. This con­fe­rence was ai­med spe­ci­fi­cal­ly at ma­na­gers and spe­cia­lists in the phar­maceu­ti­cal and me­di­cal tech­no­lo­gy in­dus­try who are in­vol­ved in the im­ple­men­ta­ti­on of the GAMP®5 gui­de­lines for the va­li­da­ti­on of com­pu­te­ri­sed systems.

The pro­gram fo­cu­sed on to­pics such as the in­te­gra­ti­on of GAMP into GxP re­gu­la­ti­ons and the use of GAMP prin­ci­ples in GMP pre­pa­ra­ti­on and the GMP pha­se. Other fo­cal points in­cluded up­dating the EU GMP gui­de­lines, map­ping tools and sys­tems to the phar­maceu­ti­cal life cy­cle, the di­gi­ta­li­sa­ti­on of pro­ces­ses in the GMP and GLP area and IT com­pli­ance from the per­spec­ti­ve of the QP (Qua­li­ty Per­son). In four par­al­lel dis­cus­sion rounds, ad­di­tio­nal re­le­vant to­pics such as SAP in­no­va­tions in the re­gu­la­ted en­vi­ron­ment, GAMP ope­ra­ting pro­ces­ses, risk ana­ly­ses and the de­bu­reau­cra­tis­a­ti­on of CSV pro­ces­ses were discussed.

With our own stand, we had the op­por­tu­ni­ty to pre­sent our in­no­va­ti­ve so­lu­ti­ons in the field of di­gi­tal do­cu­ment and qua­li­ty ma­nage­ment. We pre­sen­ted our ex­ten­si­ve port­fo­lio, which spe­ci­fi­cal­ly sup­ports com­pa­nies in suc­cessful­ly di­gi­ta­li­sing and op­ti­mi­sing their pro­ces­ses. The in­ten­si­ve ex­ch­an­ge with the par­ti­ci­pan­ts not only pro­vi­ded us with va­luable in­sights into the cur­rent chal­lenges and trends in the in­dus­try, but also en­ab­led us to make new contacts.

We would like to thank all par­ti­ci­pan­ts for the in­spi­ring dis­cus­sions and con­s­truc­ti­ve ex­ch­an­ge. We would also like to thank the event team from ISPE, APV, Con­cept Hei­del­berg and VDI/VDE-GMA for the ex­cel­lent or­ga­ni­sa­ti­on. It is with gre­at plea­su­re that we look back on a suc­cessful and va­luable participation.

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Portrait of employees discussing in the office