Medanta uses specifically designed pharmacovigilance and device-safety software and databases to deliver our outsourced services. Our main safety database is PV-Works™, a leading product recognised by regulatory agencies worldwide.

PV-Works
PV-Works is a process-driven pharmacovigilance software system that meets all international regulatory requirements and is FDA 21 CFR Part 11 compliant. The software implements your business processes ensuring SOP compliance and on-time reporting. A workflow engine is integrated to generate process-driven “To do lists”. This, along with comprehensive safety functionality, allows full control of your pharmacovigilance processes.

The software allows for comprehensive data entry, which has a complete audit trail of all entries and amendments. Data fields are validated at the point of entry, including range checks and cross-field checks and coding to MedDRA is simple. Each case that is entered has full document management, where all associated correspondence and reports are loaded, ensuring a complete and transparent document history for each case that is entered.

The pharmacovigilance database has been designed around the ICH E2B guideline such that every E2B data field maps to a specific database field. An electronic reporting function, generating all common international regulations (including FDA, CIOMS, EMEA, MHRA, AFM, BfArM) is included to allow for seamless submissions of regulatory reports.