Gene therapy products: regulatory expectations and challenges for the industry
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SMARTCHECK
A smart tool for product information maintenance
SMARTCHECK uses artificial intelligence to compare the content of product information, such as summary of product characteristics (SmPC), package information leaflets (PIL) and packaging materials. The automated service enables the comparison of specific text according to the business rules and legislation in different countries.
Co-created with Accenture, PharmaLex has accomplished time savings of up to 65% and complete reduction in error risk.
Features
- An intelligent system which supports the maintenance of medical product information e.g. packaging materials and patient information leaflets
- Uses an 80% automated process to compare the content of recent outdated or country specific documents, identifies differences and proposes necessary amendments to bring them up to date
- The tool is designed to work according to the defined business rules and customer specifications
- Final decision making and approval remains human-based
- Helps ensure that generic product are aligned to the innovator’s clinical information
Benefits
- 47% reduction of workload in regulatory process for patient information leaflets (PILs)
- 64% reduction of workload in regulatory process for Summary of Product Characteristics (SmPC)
- 21% reduction of workload for regulatory process in Artwork (Outer and Box analysis)
- 50% increase in productivity – 4 hours per active substance as opposed to 8 hours without automation
