Indulgence

Inforcom develops new Qualification Protocol for Data Migration - USFDA CFR11 compliance



June 15th 2018

#Inforcom Tech offers #VolunteersDatabase application for #CROs. Their product #VPMS - Volunteers & Project Management System is a validated application as per #CFR11-2 #compliance standard of #USFDA for #ElectronicDataStorage and accessing. 

VPMS is a preferred application for Volunteers data management at CROs for #ClinicalStudies. Many CROs have migrated to VPMS for its #compliance to #regulatory requirements. During the #migration the data from the older data system is required to be migrated to VPMS. #Inforcom offers the same service. 

The data migration, as done from backend at the database level, does not follow the data format rules and filters of the #PQ (#PerformanceQualification). Thus a special migration validation is required. This validation has to be in compliance to #USFDA #CFR11 standard. Inforcom has developed the scripts for the same. The migration scripts are put under test as well as the migrated data is validated and documented - vertically and horizontally. 

These audit scripts are part of the full validation of VPMS - #Plan, #IQ, #OQ, #PQ etc. and is audited by the national and international #AuditAgencies.