Risk-Based SDLC Workflow for Regulatory Deliverable Automation
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Solution Overview
Problem
The SDLC process is manual and time-consuming, leading to confusion, frustration, and compliance challenges, particularly in heavily regulated industries like life sciences, with organizations struggling to understand and align on regulatory requirements, resulting in delayed innovation and increased risk exposure.
Innovation Solution
A Digital SDLC system that automates the SDLC process, providing a single-source-of-truth for regulatory compliance, offering a self-service platform to manage SDLC activities, reduce manual errors, and ensure compliance through real-time data management and continuous integration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manual SDLC process is used, then flexibility in handling diverse regulatory requirements is maintained, but time consumption and error rate increase significantly
Solution Approach 1:
The patent replaces manual mechanical processes with an automated digital system that uses algorithms to determine SDLC activities and generate deliverables. The system automatically assesses applications, determines required activities based on risk profiles, and generates compliance deliverables without manual intervention, thereby increasing productivity while managing complexity through digital automation.
Solution Approach 2:
The system changes the state of SDLC management from manual to automated by introducing digital parameters such as risk profiles, activity thresholds, and automated determination criteria. These parameter changes enable the system to automatically adjust the SDLC process based on application characteristics, improving execution speed while maintaining compliance with diverse regulatory requirements.
2Reliability
If comprehensive regulatory documentation is maintained, then compliance posture is improved, but time to complete deliverables increases
Solution Approach 1:
The system performs preliminary assessment of applications to determine risk profiles before generating SDLC deliverables. By pre-determining which activities and deliverables are required based on automated risk assessment, the system eliminates unnecessary documentation steps while ensuring compliance, thereby reducing time to complete deliverables without compromising reliability.
Solution Approach 2:
The system enables self-service by automatically determining and generating compliance deliverables based on the application's risk profile. Instead of requiring manual review and selection of required documentation, the system autonomously identifies and generates appropriate deliverables, reducing time consumption while maintaining comprehensive compliance posture.
3Measurement precision
If detailed regulatory requirements are documented, then compliance accuracy is improved, but understanding and alignment among stakeholders becomes more difficult
Solution Approach 1:
The system introduces an intermediary layer that translates complex regulatory requirements into automated, application-specific deliverables. This intermediary digital layer processes detailed regulatory rules and generates simplified, actionable compliance tasks, thereby maintaining compliance accuracy while improving ease of operation for stakeholders who can focus on execution rather than interpreting complex requirements.
Solution Approach 2:
The patent replaces manual interpretation and alignment processes with automated digital determination. The system uses algorithms to interpret regulatory requirements and generate consistent deliverables, eliminating the variability and confusion that arise from manual stakeholder alignment while maintaining high compliance accuracy through consistent automated application of rules.
4Productivity
If manual SDLC process is used, then adaptability to different regulatory frameworks is maintained, but cycle time increases significantly
Solution Approach 1:
The system replaces manual SDLC processes with automated digital determination and generation of deliverables. By using algorithms to assess applications and generate compliance documentation, the system achieves high delivery speed while maintaining adaptability to different regulatory frameworks through programmable rule sets that can be configured for different industries and requirements.
Solution Approach 2:
The system changes the automation level by introducing digital parameters and automated determination criteria that enable rapid generation of compliance deliverables. These parameter changes allow the system to adapt to different regulatory frameworks through configurable rules while maintaining high delivery speed, effectively resolving the contradiction between productivity and automation extent.
Data Source
AI summary
A digital system development lifecycle system processes approval requests for applications. The system generates a risk profile using a questionnaire and selects a set of deliverables based on the risk profile. The set of deliverables is tuned based on regulatory or enterprise policies. The system provides a user interface via which users can view progress towards the tuned set of deliverables.