Under penalty-linked deadlines, Qudits led the sub-project validation of a new digital regulatory affairs SaaS platform replacing all legacy systems.
Situation
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 migrated correctly and completely to ensure the compliance of the company.
Solution
Creation of a sub-project plan and establishment of an efficient validation structure. Ongoing sub-project controlling. 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) per US FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5. Ensure correctness and completeness of migrated data.
Impact
Automation of regulatory affairs business processes through rule-based workflows. The implementation and validation of a digital SaaS platform enhances management of electronic submissions and regulatory documents, streamlining the lifecycle of pharmaceutical products.
Qudits’ role: Validation Lead
Facts & Figures
- 18 months
- 3 consultants