Accelerating QMS Implementations with CSA, Automation, and Agile Synergy 

Looking for a more efficient way to implement Quality Management Systems (QMS) in your organization? At Sikich, we help organizations navigate these challenges through a close partnership between our QMS implementation team and IT Quality & Compliance (ITQ&C) validation team. This collaboration leverages Computer Software Assurance (CSA) best practices, advanced tools, including automated testing, Validation Lifecycle Management Systems (VLMS), AI-powered solutions, and agile ways of working. This blog explores how these approaches, alongside our guidance on transitioning from Computer System Validation (CSV) to CSA, work together to accelerate value and drive transformative results. 

Key Takeaways: 

• Explore the drivers, principles, and approaches behind transitioning from CSV to CSA and how they support CSA adoption and maturity. 
• Gain practical guidance for moving from CSV to CSA in your organization. 
• See how agile methods and advanced tools help accelerate QMS implementation. 
• Learn how integrating validation activities earlier in the SDLC process reduces rework, improves system quality, and speeds time to value. 

Drivers and Key Principles for CSA Adoption 

Drivers: 

• Increasing regulatory expectations for risk-based validation approaches. 
• Pressure to accelerate Digital Transformation and reduce time to value. 
• Need to improve system quality while reducing manual effort and rework. 
• Desire to embed validation as a continuous, integrated process rather than a checkpoint. 

Key Principles 

Our CSV-to-CSA offering is guided by three core principles and begins with a current state assessment, which informs a tailored roadmap to navigate the often complex Digital Transformation journey: 

1. People: 

• Equip team members, Subject Matter Experts (SMEs), and Senior Leadership with overview of CSA best practices, adoption strategies, and qualitative/quantitative benefits. 
• Apply critical thinking and a risk-based approach to documentation, testing, and assurance activities. 
• Align validation and assurance efforts with the intended use and risk of IT assets. 
• Embrace automation and AI-powered solutions in support of continuous validation process improvement.  

2. Process: 

• Move from a “one size fits all” validation approach to a flexible, risk-based framework using Agile and iterative methods. 
• Revise System Development Life Cycle (SDLC) and CSA-related policies to enable adoption of CSA best practices, such as leveraging supplier documentation and risk-based testing. 
• Conduct risk assessments at the functional requirement level rather than the system level. 
• Identify opportunities for automated testing, like regression testing for routine system upgrades. 
• “Shift left” in the project timeline to allow business users to explore and test the configured system before formal validation. 

3. Technology: 

• Leverage automated testing to reduce manual effort and support AI-powered solutions, including validating model outputs and continuously monitoring performance to ensure reliability and compliance. 
• Utilize a VLMS to streamline documentation and efficiently manage manual testing activities. 
• Identify opportunities for AI to reduce repetitive or redundant tasks. 

Agile Ways of Working as a Foundation for Flexibility and Speed 

Our agile approach to QMS implementation focuses on delivering measurable value early and continuously. By leveraging project management tools and structuring projects into iterative sprints, we foster close collaboration, transparency, and adaptability throughout the lifecycle: 

• Leverage industry-leading agile project management tools like JIRA to effectively plan, track and manage the project team’s workload and Business’ User Stories. 
• Incremental delivery of requirements, configurations, and process improvements—developed and refined hand-in-hand with Business stakeholders. 
• Sprint-based transparency and adaptability, allowing teams to respond quickly to shifting priorities, regulatory expectations, or process refinements without derailing timelines. 
• Parallel validation and development, where testing, documentation, and quality reviews progress alongside system build activities – minimizing rework and accelerating time to go-live. 
• Continuous Improvement via post-Sprint retrospectives to optimize the remaining Sprints or future releases. 

By embedding the CSA principles within this agile framework, compliance becomes an integrated strength of the process – streamlined, risk-based, and supportive of innovation rather than restrictive to it. 

Ready to accelerate your Digital Transformation journey and QMS delivery? 

Contact Sikich to learn how our QMS implementation approaches can help your organization adopt CSA best practices and agile-driven frameworks that remove the traditional challenges of validation and improve system quality and compliance.