Automated Compliance Platform for Clinical Trial Software
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Solution Overview
Problem
Software suppliers face significant challenges in providing regulatory-compliant software solutions due to the high costs and complexities of adhering to regulatory requirements in markets governed by bodies like the FDA or EPA, particularly in clinical trials, where legacy practices and compliance with electronic records and signatures regulations can be laborious and costly.
Innovation Solution
A compliant software production system that automates validation, proving-in, auditing, and continuous monitoring of software applications, allowing suppliers to outsource compliance to a third-party provider, which includes validation blocks, infrastructure proving-in, and operational change management, ensuring regulatory compliance without requiring suppliers to have in-house expertise or infrastructure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If software suppliers develop in-house regulatory compliance infrastructure and expertise, then regulatory compliance capability is improved, but cost and complexity increase significantly
Solution Approach 1:
The patent introduces a third-party compliance provider as an intermediary between software suppliers and regulatory bodies. This intermediary performs validation, auditing, and compliance monitoring functions that would otherwise require suppliers to build complex in-house infrastructure. The compliance provider acts as a mediator that simplifies the compliance process for suppliers while maintaining regulatory standards.
Solution Approach 2:
The system enables automated self-validation and self-auditing capabilities through continuous monitoring and automated compliance checking. Software applications can automatically demonstrate their compliance status without requiring manual intervention from suppliers, reducing the need for complex human-operated compliance infrastructure.
2Reliability
If software suppliers implement comprehensive validation and auditing processes, then regulatory compliance is improved, but time and resource consumption increase
Solution Approach 1:
The patent implements continuous monitoring and validation processes that operate ongoing rather than as periodic batch operations. This allows compliance to be maintained continuously through automated processes, reducing the total time required for validation by spreading the work over time and avoiding lengthy periodic audits.
Solution Approach 2:
The system replaces manual validation and auditing processes with automated computational processes. Software applications are automatically validated and audited through machine-based processes rather than human reviewers, significantly reducing the time required for compliance verification while maintaining thoroughness.
3Adaptability or versatility
If smaller software suppliers attempt to achieve regulatory compliance independently, then market access is improved, but cost prohibitions prevent entry
Solution Approach 1:
The patent creates a universal compliance platform that serves multiple software suppliers across different applications and regulatory domains. This multi-functional system provides validation, auditing, and monitoring capabilities that can be accessed by any supplier, eliminating the need for each supplier to develop their own specialized compliance infrastructure.
Solution Approach 2:
By introducing a third-party compliance provider as an intermediary, smaller suppliers gain access to regulatory compliance capabilities without needing to build expensive in-house infrastructure. The intermediary absorbs the complexity and cost of compliance management, making market access feasible for smaller players.
Data Source
AI summary
A system for producing a clinical trial software application includes a processor, comprising a validation service and an audit service, and a platform, configured to prove-in an infrastructure on which the software application operates. The software application operating on the infrastructure is the same as the software application previously validated in a validation portal. The proving-in of the infrastructure comprises receiving infrastructure requirements from a software application supplier, building the software application supplier's instances, logging an installation report to the validation portal, and comparing the log to the frozen, validated software in the validation portal. The validation service is configured to validate the software application, freeze the validated software application in the validation portal, and generate documentation that satisfies compliance rules for the clinical trial software application. The validation service receives software code, testable requirements, and test results from a software application supplier and generates documentation regarding the validation of the software application. The audit service is configured to provide evidence of operational change management for a regulatory agency according to compliance rules of the regulatory agency. A method for producing regulatory-compliant software is also described and claimed.