Page Comparison

Cross-walk of Field Guide Topics to Delivery of Packaged Documents

Relevant Documents

Introduction CPG Authoring is on Google Docs. Click here to access the document. https://drive.google.com/file/d/1I-3DceF3_y_cX7f7O0AIBldhIYhlEBoz/view?usp=sharing

The Business and Compliance section is on Google Docs. Click here to access the document. https://drive.google.com/file/d/1zr6lFaa5DJ6aQsDUVdjyI2P0OtafydT1/view?usp=sharing 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.