Big Pharma Challenges
- Usually, most of the labeling is manual, copy/paste & repetitive, manual reconciliations of data points, a lot of QC checklists, and so on
- Heavily document focused and digitization is always “next year” project
- Having separate labeling focused software tough to justify cost and sustenance
Mid/Small Pharma Challenges
- With fewer products in the market, a labeling system not on priority (from Business/Finance team perspective)
- Maintained in documents (on desktops, shared drives, or general EDMS) and with less traceability
- Knowledge in fewer hands (out of the door when they leave)
Our solutions help in bringing efficiency and save time/cost by right amount of digitization and automation
Core Labeling: The Solution enables you to “digitally” create and maintain the lifecycle of all core labels like CCDS/CCPI and some key labels like SmPC/USPI linking to CCDS. With effective impact analysis built-in, decide effective changes and once done, trickle-down those to other labels thereby reducing manual copy/paste and QC aspects.
Local Country Labeling: With live Reg intel built-in, local country labeling (both new and maintenance) saves you over 70% of the time. With few clicks, you can do change control, analyze data, assessment, compare CCDS changes, and update/finalize local label content. Includes multiple comparisons (more than one local label and CCDS), hybrid comparisons (EU SmPC, CCDS, USPI, and local label), regulatory submission-type comparison, Localization, and QC.
Label Compliance: As all labeling content and actions are linked well in the tool, Compliance management is at ease. All local label deviations and local deviation safety compliance can be viewed by simple reports by change, by version, by country, and by the user. HQ team also will have options to set rules/controls for alerts on deviations.
Change Management: Regulatory change management is included where variations can be proposed, created, and tracked until implemented in the core labels. Changes proposed for core labeling processes are extended sequentially to the processes at each level (LPD, Artwork, Printing, and Supply Chain). Our solution can recognize the countries impacted by the proposed labeling changes and notify the concerned stakeholders on the change, well before the CCDS distribution.