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Line 1: − + − Successful transformation relies on the alignment of compliance and enforcement programs’ mindset across the branch, from senior management right through to the front line staff. To do this, the [[ROEB Transformation Office]] was created.+ − + + Line 11:
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Line 57: − − ===Enterprise Investment Plans=== − ====IP 628==== − There are a number of different post-market programs at Health Canada that authorize applicants to conduct regulated activities, against regulated products, at specific locations. These include: − − * Medical Device Establishment Licensing (RORB) − * Natural Health Product Site Licensing (HPFB) − * Controlled Substances Dealer Licensing (HECSB) − * Drug Establishment Licensing (RORB) − − There are two active IP projects (CSPS and e-CES) that include this functionality. It is also expected that the Cannabis legalization program will require this functionality. − − Most programs in this space are using systems with growing aging IT risks, or are still having to use paper and spreadsheet based processes. − − Intended direction is to identify and acquire a highly configurable COTS product that is targeted at the regulatory licensing space. This solution will be available to all programs as their primary option for this capability. − − Functionality that is within scope of solution is: − − * application intake, review, and triage − * inspections that support licence decisions − * risk assessment − * decision workflow − * license/permit generation and notification − * calculation & collection of license fees (cost recovery) − − ==== '''IP 634''' ==== − − ====IP 701: Border IM/IT Modernization ==== − Invest in a modern IM/IT system for the Health Products Border Program to bring their data collection and management processes onto a single mobile platform, with the following key features: − − * Workload management − * Process standardization − * Data quality and structure − * Enterprise collaboration − * Reporting − − This IT system will replace two Lotus Notes databases and numerous Excel spreadsheets being used by the health products border program. This initiative is closely linked with Business Analysis/Risk Intelligence initiatives outlined above. − − ==== + other projects like MERLIN & CS & TVCEP ==== − − ==== '''IP 704: Quality Management System''' ==== − System for Quality Management (ISO 9001:2000): is part of a suite of databases designed specifically to meet the requirements of ISO 9001:2000, the QSI System for Quality Management helps an organization reap the benefits of ISO certification, including improved customer satisfaction and reduced costs. QSi, the software suite used to manage a Quality Management System (QMS) is currently unsupported and is housed on an Aging IT Platform (Lotus Notes). The software suite is inherently unstable and contains many bugs. The RORB programs using QSi (Labs, HPCD, MDCCD) are concerned of a system collapse and how it could potentially impact current Accreditation and Mutual Recognition Agreements in place. − − '''IP 705: DAS Modernization''' − − Modernization of the DAS Labs business proecess and introduction of an end-to-end IT solution for the submission, triage, assessment, and issuance of the DAS Certificate of Analysis. − − '''DHPID Updates'''
structure changes
[[ROEB-Transformation|ROEB Transformation]] is a movement to evolve the Regulatory Operations and Enforcement Branch (ROEB) at [[Health Canada]] into the digital era, by all employees for all Canadians.
[[ROEB-Transformation|ROEB Transformation]] is a movement to evolve the Regulatory Operations and Enforcement Branch (ROEB) at [[Health Canada]] into the digital era, by all employees for all Canadians.
Today’s regulatory landscape is complex and continually evolving, through rapid scientific innovation, technological advances and global supply chains. ROEB is committed to modernizing and transforming its compliance and enforcement approach to become more agile, assertive, consistent, innovative, proactive and risk-based. The strategic plan sets the vision for being a world class compliance and enforcement leader, as supported by the [[Multi-year C&E Transformation]] plan, which directs and coordinates transformation efforts across [[ROEB’s compliance and enforcement programs]]. Successful implementation of the [[MYCET]] will require consistent, dedicated leadership and accountability from management, including oversight and reporting at the portfolio level.
Today’s regulatory landscape is complex and continually evolving, through rapid scientific innovation, technological advances and global supply chains. ROEB is committed to modernizing and transforming its compliance and enforcement approach to become more agile, assertive, consistent, innovative, proactive and risk-based. Digital Transformation will be a key component to drive change required to thrive in a digital world. ROEB's [[Strategic plan|Strategic Plan]] sets the vision for Digital Transformation to enable ROEB as a world class compliance and enforcement leader.
The [[ROEB Transformation Office|Transformation Office]] was established to both support and lead this transformation movement by collaborating with compliance and enforcement programs to curate the mindset critical for change. As part of this movement, the Transformation Office, in collaboration with many divisions and programs within ROEB and beyond, is testing and applying novel technologies to advance compliance and enforcement into the digital era. [[File:TO Placemat.png|thumb]]
[[File:TO Placemat.png|thumb]]
===Technology Being Tested===
===Technology Being Tested===
====Natural Language Processing (Artificial Intelligence):====
====Natural Language Processing (Artificial Intelligence):====
There are several projects testing [[wikipedia:Natural_language_processing|Natural Language Processing]] to support uses cases within ROEB. [[Project Cipher]] is a prime example of this technology to support the inspection programs. [[Project Cipher]] began as a [[Solutions Fund]] project to test the technology applied to inspection observations to create an automated process to assign risk to each observation and other business process requirements critical within many inspection programs (for example: assignment of "Standard Lines").
====Robotics & Remote Sensing (Drones and Satellites)====
====Robotics & Remote Sensing (Drones and Satellites)====
As part of a Solutions Fund project called [[Hummingbird]], ROEB has been testing data collected using drones and satellites to assess value when applied to outdoor cannabis inspections. To find out more, please visit the [[Hummingbird]] [https://022gc-my.sharepoint.com/:f:/r/personal/peter_yoon_hc-sc_gc_ca/Documents/Hummingbird?csf=1&web=1&e=BPdGag repo].
As part of a Solutions Fund project called [[Hummingbird]], ROEB has been testing data collected using drones and satellites to assess value when applied to outdoor cannabis inspections. To find out more, please visit the [[Hummingbird]] [https://022gc-my.sharepoint.com/:f:/r/personal/peter_yoon_hc-sc_gc_ca/Documents/Hummingbird?csf=1&web=1&e=BPdGag repo].
====Computer Vision (Artificial Intelligence):====
====Computer Vision (Artificial Intelligence):====
[[Cyclops]], an ROEB Solutions Fund project, leverages computer vision to detect and interpret text in images via optical character recognition. This technology supports checking instances of non-compliance in natural health project labels examined by inspectors.
Project [[Cyclops]], a ROEB Solutions Fund project, leverages computer vision to detect and interpret text in images via optical character recognition. This technology supports checking instances of non-compliance in natural health project labels examined by inspectors.
====Virtual Reality:====
====Virtual Reality:====
[[Project Apollo]] started
====Augmented Reality (mixed reality):====
====Augmented Reality (mixed reality):====
====Social Media Monitoring (Artificial Intelligence):====
====Social Media Monitoring (Artificial Intelligence):====
Kelpie
Project Kelpie
====Data Lakes (Data Sharing):====
====Data Lakes (Data Sharing):====
==== Geographic Information Systems: ====
==== Geographic Information Systems: ====
Project
==== Web Scraping ====
==== Web Scraping: ====
Project Sparrow
====Robotic Process Automation ====
====Robotic Process Automation ====
Pilot with UiPath (Medical Device)
- pilot with Blueprism (ALR)
- pilot with Blueprism (ALR)
=== Technology Being Used ===
=== Technology Being Used ===
- Vidcruiter
- Vidcruiter
