Shelf Readiness: Difference between revisions
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=Introduction=
=What is meant by the term “Shelf-Ready”?=
The term "shelf-ready," and the broader concept of "shelf readiness," stem from the need to ensure that digital health global goods, particularly software, are ready to be deployed as stand-alone products which meet the primary data use needs of a tool. While not referring to a monolithic approach the concept of stand-alone refers to the tools being packaged and complete in the view of having available and installed all required dependencies and functions to achieve the intended feature sets. Shelf readiness aims to allow implementers and decision makers to have a higher level of confidence in the solutions as they would be well presented in their product information, ability to perform desired functions as well as interoperability workflows / metadata synchronizations and deployment aspects, to name a few areas.


Digital Square has framed three tiers of shelves around the scaffolding of the OpenHIE architecture to describe conceptual groupings of tools within the space; with the first set of shelves framed around the (i) Business Domain Services, (ii) Metadata Management/Registry Services and (iii) Point of Services.  
A "shelf-ready software global good " provides those who evaluate and implement digital health global goods with the confidence that the product meets the described functions, is quality assured and includes all the necessary information and tools needed to evaluate, deploy, test, implement and operationalize the global good. Shelf-ready software is designed to be interoperable using appropriate open data exchange standards.
 
A "shelf-ready" software global good:
* has a comprehensive set of versioned, up to date documentation for different target audiences.
* can demonstrate evidence of the quality assurance processes and testing for all the main functions and feature sets.
* provides information about the open standards that are supported or on the development roadmap and describes how it aligns with the OpenHIE architecture.
* is easily deployed, can be validated as having been correctly deployed, and provides resources for developers, implementers and end users that support easier, faster and more effective use of the software.
* has been scanned for security vulnerabilities.
 
Digital Square describes three tiers of shelves aligned with the OpenHIE architecture, namely: (i) Business Domain Services, (ii) Metadata Management/Registry Services and (iii) Point of Service applications.


[[File:Shelf Ready.png]]
[[File:Shelf Ready.png]]


Technologies and software that are shelf ready should strive to support the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of software validation, in both tool and implementation, and through this allow themselves to showcase their readiness for safe and effective use and function. Digital Square has outlined the following framework in guidance of technologies that are shelf ready. The framework flows around the following areas:  
==The Shelf Readiness Evaluation Matrix==
 
This matrix may be used to perform an assessment of software across several key areas, to provide an indication of the current state of shelf-readiness, areas where improvements may enhance shelf-readiness and a means of evaluating progress towards shelf-readiness.  The matrix includes the indicator and sub-indicator definitions and a self-assessment tool that produces scores for each indicator. 
 
==Shelf-readiness and the global goods maturity model==
 
Shelf-ready software show a high level of maturity across the [https://wiki.digitalsquare.io/index.php/What_are_Global_Goods#Maturity_Model global goods maturity model]. While high scores across all dimensions are ideal, achieving the levels indicated below are prioritized:
 
==Shelf-readiness Indicators==


==Global Goods Maturity Model==
===Installation and deployment===  
Shelf-ready software and tools show a high level of maturity across the [https://wiki.digitalsquare.io/index.php/What_are_Global_Goods#Maturity_Model global goods maturity model]. While high scores across all dimensions are ideal, achieving the levels indicated below are prioritized:
Software tools and technologies follow international industry conventions to support enterprise installation and deployment patterns and should also strive to support the Instant OpenHIE deployment and configuration requirements, including: i) containerisation approaches that are harmonised with Instant OpenHIE; ii) Development of synchronization tools (e.g., OpenHIM mediators) between the software tool and metadata registries (facility, client, terminology) using appropriate IHE profiles of HL7 FHIR.; iii) Scripted configurations and data sets (as required) to showcase the functionality of base use cases; iv) Existing documentation that allows implementers to validate that the initial installation of the tool is as per expected to support IQ (including expected state of successful installation, installation reports validating all services are operational, initial system check tests to support successful and correct installation, etc.)


*Global Utility
=== Quality assurance and testing===
**Digital Health Interventions (High)
Shelf-ready software shows empirical evidence of quality assurance practices to validate both the safety and functionality of the tool. There should be documented consistent evidence that the software meets the functional requirements and is also built as expected. Shelf-ready tools have a documented testing strategy that covers all major risk areas and business critical functions and include testing strategies to mitigate failure in these areas. Testing strategy should be operationalized in a testing framework that is applied against the tool in a repeatable manner and the QA plans and reports, as well as available indicators outlining the level and coverage of testing, should be available for review by both technical and non-technical audiences. Shelf ready software should strive to support the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of software validation during implementation, that demonstrates its readiness for safe and effective use.
**Source Code Accessibility (High)
*Community Support
** Software Roadmap (medium)
**User Documentation (medium)
**Multi-lingual Support (medium)
*Software Maturity
**Technical Documentation (medium)  
**Software Productization (medium)
**Interoperability & Data Accessibility (medium)
**Security (medium)
**Scalability (medium)


Further refinement of this model would see that software and tools exhibit strong features and functionality in the areas of:
===Product information and documentation===
Shelf-ready tools provide software product information and documentation that cater to both technical and non-technical target audiences. Product information includes a summary of the value proposition and major functions of the tool, serving as a concise reference document for decision makers. Product documentation for shelf-ready goods is comprehensive, covering all aspects needed to support an effective and safe implementation and sustainable operational use of the tool. Product documentation includes developer documentation, implementer documentation, administrator guides, end user guides and operation manuals. See Tab 3 for examples.


===Installation and Deployment===  
===Alignment with OpenHIE Architecture and open standards===  
Tools and technologies should not only follow international conventions to support industry and enterprise installation and deployment patterns but strive to support the [https://wiki.ohie.org/display/resources/Instant+OpenHIE Instant OpenHIE] deployment and configuration requirements to form part of the large infrastructure. This is inclusive of:
Shelf-ready software tools are categorised according to the OpenHIE architecture framework (business domain service, registry/metadata service, point-of-service , interoperability layer) and adhere to the clearly defined data exchange patterns and flows. Software is aligned to the OpenHIE architecture and facilitates the required interactions to support the key use-cases that the software is designed for. For example, patient oriented point of service systems should be able to register and query patients and their demographic data with a client registry and should be able to synchronize health facility lists with a facility registry.


*Harmonized containerization approaches with the Instant OpenHIE project.
=== Alignment with DevOps guidelines=== 
*Development of synchronization tools (e.g., OpenHIM mediators) between the software tool and metadata registries (facility, client, terminology) using appropriate IHE profiles of HL7 FHIR. 
Shelf-ready software is aligned with industry-wide DevOps guidelines, providing guidance on factors to consider when deploying solutions. This may include considerations for a migration path from local hosting to international cloud services. Shelf-ready global goods provide a change management guideline for the transition from local data centers to cloud and take into account the need to harmonize on a common approach to DevOps across digital health tools.
*Scripted configurations and data sets (as required) to showcase the functionality of base use cases.  
*Existing documentation that allows implementers to validate that the initial installation of the tool has been completed successfully as per the Installation Qualification (IQ). The Installation Qualification consists of two parts: the validation of the ICT infrastructure (power, connectivity, physical security) to ensure it meets the agreed system requirements; and the validation of the deployment of the software to ensure it is installed and functioning correctly.  The IQ reports produced by the execution of the test protocols should provide a complete record of the computer system installation validation at a point in time to provide assurance that all system services are operational.


===Quality Assurance and Testing===  
=== Security===  
Strong and empirical evidence of well-thought-out quality assurance patterns to validate functionality and provide a sustained and consistent base of evidence that the software both meets the functional requirements or feature sets but also is built as expected. Shelf-ready tools should strive towards having a documented testing strategy that covers any major risk areas and business critical functions and include testing strategies to mitigate failure in these areas. This testing strategy should be operationalized in a testing framework that is applied against the tool in a repeatable manner and the QA plans and reports, as well as available indicators outlining the level and coverage of testing should be available for review.  
Shelf-ready software shows evidence of good security practices, including having a documented security policy, security assessments and security measures in place, and has undergone vulnerability testing.


===Product Information and Documentation===  
==IQ,OQ,PQ Validation Framework==
Shelf-ready tools should differentiate the product information and documentation artifacts and cater to the required audiences. Product information should outline in a summary form the key functions and value proposition of the tool and serve as a quick access document for decision makers to understand the value proposition and value gained from the tool (the brochure, so to say). In addition, Product Documentation for shelf-ready goods should be comprehensive and inclusive of all aspects to support an effective and safe implementation and ongoing operations of the tool in the field. Product documentation should include not only developer documentation (software design, patterns, etc.), but also implementer documentation (installation guides, architectural implementation patterns for scale, implementation validation checks, etc.), administrator guides (configuration option and descriptions of all features and options, etc.), user guides and operation manuals (outlining the functionality of the system as well as how it operates).


==Supports standards for data exchange as appropriate for the tool and aligned with the OpenHIE architecture==
Software that is shelf ready should strive to support the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) system validation framework. This framework is used to validate implementations in these key areas:
Shelf-ready software tools are well categorized within the business functional domain or as a registry/metadata service or point-of-service solution and, as such, adhere to clearly defined data exchange patterns and flows. The solutions are well aligned to the OpenHIE architecture and facilitate the required interactions to support the key use-cases that are proposed and advertised as supported by the technology. As an example, Point of Services systems interacting with patients would be well suited to register and query patients and associated demographics with a client registry and should be able to synchronize health facility lists with a Facility Registry.  
*that the infrastructure is sound,
*that the software has been correctly installed,
*that the software meets the specified requirements,
*that the system, people and SOPs are able to function in the environment as intended.


==Aligns with DevOps and Cloud-Services Guidelines==
This showcases the software readiness for safe and effective use.
Shelf-ready tools and technologies look to ensure that they are aligning to emerging guidelines such as the [https://docs.google.com/document/d/1daVn-xxxuhQvFzA4sIY2vsDnJxh7AV8DxbB8wkvZNpg/edit?usp=sharing DevOps and Cloud-Services guidelines]. These look to provide guidance on some of the major areas of consideration for the deployment of implementations within and for countries. These considerations often require a migrating path from local hosting to international cloud services. Shelf-ready global goods should provide a change management path/guideline for the transition from local data centers to cloud, and take into account the need to harmonize on  a common approach to DevOps across digital health tools.

Revision as of 09:39, 11 October 2023

What is meant by the term “Shelf-Ready”?

A "shelf-ready software global good " provides those who evaluate and implement digital health global goods with the confidence that the product meets the described functions, is quality assured and includes all the necessary information and tools needed to evaluate, deploy, test, implement and operationalize the global good. Shelf-ready software is designed to be interoperable using appropriate open data exchange standards.

A "shelf-ready" software global good:

  • has a comprehensive set of versioned, up to date documentation for different target audiences.
  • can demonstrate evidence of the quality assurance processes and testing for all the main functions and feature sets.
  • provides information about the open standards that are supported or on the development roadmap and describes how it aligns with the OpenHIE architecture.
  • is easily deployed, can be validated as having been correctly deployed, and provides resources for developers, implementers and end users that support easier, faster and more effective use of the software.
  • has been scanned for security vulnerabilities.

Digital Square describes three tiers of shelves aligned with the OpenHIE architecture, namely: (i) Business Domain Services, (ii) Metadata Management/Registry Services and (iii) Point of Service applications.

Shelf Ready.png

The Shelf Readiness Evaluation Matrix

This matrix may be used to perform an assessment of software across several key areas, to provide an indication of the current state of shelf-readiness, areas where improvements may enhance shelf-readiness and a means of evaluating progress towards shelf-readiness. The matrix includes the indicator and sub-indicator definitions and a self-assessment tool that produces scores for each indicator.

Shelf-readiness and the global goods maturity model

Shelf-ready software show a high level of maturity across the global goods maturity model. While high scores across all dimensions are ideal, achieving the levels indicated below are prioritized:

Shelf-readiness Indicators

Installation and deployment

Software tools and technologies follow international industry conventions to support enterprise installation and deployment patterns and should also strive to support the Instant OpenHIE deployment and configuration requirements, including: i) containerisation approaches that are harmonised with Instant OpenHIE; ii) Development of synchronization tools (e.g., OpenHIM mediators) between the software tool and metadata registries (facility, client, terminology) using appropriate IHE profiles of HL7 FHIR.; iii) Scripted configurations and data sets (as required) to showcase the functionality of base use cases; iv) Existing documentation that allows implementers to validate that the initial installation of the tool is as per expected to support IQ (including expected state of successful installation, installation reports validating all services are operational, initial system check tests to support successful and correct installation, etc.)

Quality assurance and testing

Shelf-ready software shows empirical evidence of quality assurance practices to validate both the safety and functionality of the tool. There should be documented consistent evidence that the software meets the functional requirements and is also built as expected. Shelf-ready tools have a documented testing strategy that covers all major risk areas and business critical functions and include testing strategies to mitigate failure in these areas. Testing strategy should be operationalized in a testing framework that is applied against the tool in a repeatable manner and the QA plans and reports, as well as available indicators outlining the level and coverage of testing, should be available for review by both technical and non-technical audiences. Shelf ready software should strive to support the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of software validation during implementation, that demonstrates its readiness for safe and effective use.

Product information and documentation

Shelf-ready tools provide software product information and documentation that cater to both technical and non-technical target audiences. Product information includes a summary of the value proposition and major functions of the tool, serving as a concise reference document for decision makers. Product documentation for shelf-ready goods is comprehensive, covering all aspects needed to support an effective and safe implementation and sustainable operational use of the tool. Product documentation includes developer documentation, implementer documentation, administrator guides, end user guides and operation manuals. See Tab 3 for examples.

Alignment with OpenHIE Architecture and open standards

Shelf-ready software tools are categorised according to the OpenHIE architecture framework (business domain service, registry/metadata service, point-of-service , interoperability layer) and adhere to the clearly defined data exchange patterns and flows. Software is aligned to the OpenHIE architecture and facilitates the required interactions to support the key use-cases that the software is designed for. For example, patient oriented point of service systems should be able to register and query patients and their demographic data with a client registry and should be able to synchronize health facility lists with a facility registry.

Alignment with DevOps guidelines

Shelf-ready software is aligned with industry-wide DevOps guidelines, providing guidance on factors to consider when deploying solutions. This may include considerations for a migration path from local hosting to international cloud services. Shelf-ready global goods provide a change management guideline for the transition from local data centers to cloud and take into account the need to harmonize on a common approach to DevOps across digital health tools.

Security

Shelf-ready software shows evidence of good security practices, including having a documented security policy, security assessments and security measures in place, and has undergone vulnerability testing.

IQ,OQ,PQ Validation Framework

Software that is shelf ready should strive to support the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) system validation framework. This framework is used to validate implementations in these key areas:

  • that the infrastructure is sound,
  • that the software has been correctly installed,
  • that the software meets the specified requirements,
  • that the system, people and SOPs are able to function in the environment as intended.

This showcases the software readiness for safe and effective use.

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