Cross-walk of Field Guide Topics to Delivery of Packaged Documents
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Relevant Documents
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1.01 Introduction
Clinical decision support software (CDSS) is regulated in many countries as a medical device. Regulations on medical devices tend to follow those for pharmaceuticals. The core requirements relate to Good Manufacturing Practices (GMP).
1.02 Administrative Tasks
Description of the organization
Specification of the responsibilities
1.03 Policies and Documentation
Policies for critical functions
Initial training and periodic education with documentation
Internal production control
Conformance with good practices for security and HIPAA
Literature sources and evidence
1.04 Documentation of Testing and Review
Testing protocol (initial, periodic, after change).
Other quality assurance measures.
Long-term record retention (training, testing).
1.05 Maintenance and version control
Keeping content up to date.
Updates and corrections.
Version control
1.06 Operations
Contact hot-line for problems
Protocol for responding to identified problems, including notification of regulatory agency and users.