70
edits
Changes
Jump to navigation
Jump to search
Line 1:
Line 1: − Regulatory Operations and Enforcement Branch, Technology and Business Innovation (TBI) unit, in partnership with [https://www.canada.ca/en/health-canada/corporate/contact-us/drug-good-manufacturing-practices-unit-inspectorate.html Health Product Inspection Licensing] (HPIL) initiated Project Cipher to take an innovative approach to better understand and leverage historical inspection data to simplify the day-to-day tasks of inspectors and make their jobs easier. + − −
no edit summary
[[Health Canada]] conducts on-site inspections of manufacturing, packaging, labeling, importing, wholesaling and distributing establishments for numerous health product lines: drugs, medical device, biologics and cannabis. These inspections produce written reports that details observations, non-compliance issues and regulatory decisions specific to individual establishments. Although this process satisfies the inspection activity within our regulatory framework, there is an opportunity to leverage the power of analysis with continuous data to inform horizontal programs with greater insight. Regulatory Operations and Enforcement Branch initiated Project Cipher to take an innovative approach to better understand and leverage historical inspection data to simplify the day-to-day tasks of inspectors and make their jobs easier.
[[Health Canada]] conducts on-site inspections of manufacturing, packaging, labeling, importing, wholesaling and distributing establishments for numerous health product lines: drugs, medical device, biologics and cannabis. These inspections produce written reports that details observations, non-compliance issues and regulatory decisions specific to individual establishments. Although this process satisfies the inspection activity within our regulatory framework, there is a lost opportunity to leverage the power of analysis on continuous data to inform horizontal programs with greater insight.
=== EXPERIMENTATION ===
=== EXPERIMENTATION ===
