Product labeling at Novartis
The customer
Novartis was faced with finding ways to track and speed up the implementation of its decisions on safety label changes into the product labeling of all pharmaceutical products worldwide. This includes changes to the health care professional information, as well as the patient leaflet included in the packaging of the products. The goal was to minimize the time between a decision to change the safety label and the product information reflecting this change.
Logica solution
- Drives the labeling processes through document management workflows
- Automates or reduces effort and reuses source text where possible
- Enables XML authoring (core data sheet and SPL/PLR/PIM)
- Manages document lifecycle, document distribution and document status
- Implements a CFR 21 Part 11 compliant system
Customer benefits
- Increased speed of information release reduces potential risk to patients and potential financial, legal and reputation risk to the customer
- Manage and ensure compliance across the organization
- Transparent and efficient management of approximately 70’000 labeling documents per year
- Transparent tracking of Safety Label Change implementation
- Ensures business continuity through a controlled GxP compliant document environment
