Togethe , Complia ceQuest a d Zolo PCS will help FDA impleme t a mode , secu e, AI-e abled quality ma ageme t solutio built o the Salesfo ce FedRAMP Gove me t Cloud platfo m. The solutio is desig ed to st e gthe complia ce, imp ove co siste cy, st eamli e quality p ocesses, a d delive g eate i sight ac oss FDA’s ce te s a d offices.
The i itiative will focus o fou p io ities:
Co ected Quality Ope atio s: B i gi g docume t co t ol, t ai i g, cha ge, CAPA, audits, othe key p ocesses coupled with epo ti g to suppo t co siste t executio ac oss the sites, fu ctio s, a d o ga izatio al u its.T usted Data a d E te p ise Visibility: C eati g a ce t alized fou datio fo quality, isk a d complia ce data with e d-to-e d t aceability a d eal-time i sight ac oss the age cy.I tellige ce a d Automatio : Applyi g AI a d i tellige t automatio to accele ate i vestigatio s, su face eleva t i sights, ide tify eme gi g isks, a d suppo t bette decisio s.Secu e, Scalable Fede al Delive y: Combi i g a platfo m built to suppo t la ge use populatio s, g owi g data volumes, a d evolvi g egulato y equi eme ts with Zolo PCS’s fede al expe tise i cloud, cybe secu ity, systems i teg atio , a d agile delive y.
The FDA i itiative eflects a b oade shift ac oss egulated e vi o me ts. As ope atio al complexity, egulato y expectatio s, a d quality data volumes g ow, o ga izatio s a e movi g beyo d i dividual quality p ocesses towa d co ected, e te p ise-wide app oaches. Complia ceQuest’s QRC platfo m is built fo this model, u ifyi g Quality, Risk a d Complia ce ac oss P oduct, Quality, Ma ufactu i g, People, Supplie s, a d Custome s o a si gle, co ected system.
“Quality ma ageme t is evolvi g f om i dividual systems a d p ocesses towa d co ected e te p ise platfo ms,” said P asha th Raje d a , CEO of Complia ceQuest. “We a e p oud to pa t e with Zolo PCS to suppo t FDA’s quality system mode izatio . This wo k highlights the g owi g eed fo tech ology that ca meet the complexity, igo , secu ity, a d evolvi g equi eme ts of highly egulated e vi o me ts.”
“We a e ho o ed by FDA’s co fide ce i ou team a d p oud to suppo t its vital public health missio ,” said Goutham Ama e i, P eside t of Zolo PCS. “Mode izi g quality ma ageme t at this scale takes both the ight platfo m a d the ight delive y pa t e . Togethe with Complia ceQuest, we a e b i gi g FDA a secu e, AI-e abled solutio built fo the igo of fede al ope atio s.”
