PROJECT REFERENCEIMPLEMENTATION AND VALIDATION OF A DIGITAL RA PLATFORM SOLUTION (SAAS)APPROACH

PROJECT REFERENCE
IMPLEMENTATION AND VALIDATION OF A
DIGITAL RA PLATFORM SOLUTION (SAAS)
RESULTS & BENEFITS
Implementation and validation of a digital RA platform to manage electronic submissions and regulatory documents for compiling, publishing, importing and reviewing, providing an overview of all product information and managing all regulatory activities in the lifecycle of pharmaceutical products and finally automating business processes by adopting rule-based workflows related to regulatory affairs.
In addition, the old systems will be replaced, and the data migrated.
CUSTOMER
International pharmaceutical company, headquarter in Italy
CHALLENGES
Within a limited period of time linked with penalty payments, all old systems will be replaced, the new ones will be implemented and validated and the data will be transferred correctly and completely to ensure the compliance of the company.
APPROACH
Creation of a sub-project plan and establishment of an efficient validation structure. Ongoing sub-project controlling (budget, scope, schedules, resources, quality). Review of relevant documentation as well as planning, creation and execution of software validation according to GAMP5 (VP, URS, FS, CS, IQ, OQ,
PQ, MQ, VR). Ensure correctness and completeness of migrated data.
FACTS & FIGURES
18 months | 3 consultants
QUDITS ROLE
Sub-project management | Validation lead