Mastering Regulatory Compliance and Sustained Quality

 

Mastering Regulatory Compliance means going beyond the basic rudiments of in the execution of your processes to a higher level of mastery and best practices.  Pharmaceutical and healthcare companies are adopting advanced cloud-based technologies, the Internet of Things (Iot), mobility and many other technologies at an increasing pace.  The challenges associated with cGxP compliance and other predicate rule requirements are now coupled with issues concerning cybersecurity and data integrity. 

The principles of Validation and verification for computer systems endures and yet many pharmaceutical and healthcare companies are still conducting manual validation exercises on paper and using non-automated workflow processes to review and approve validation deliverables.

LEAN VALIDATION FOR PHARMACEUTICAL & HEALTHCARE COMPANIES

We practice LEAN VALIDATION.  OnShore Technology Group understands the unique requirements facing today’s pharmaceutical companies and we are ever-seeking new ways to address the unique challenges of this market sector.  Lean validation strategies are designed to automate the validation process while eliminating wasteful, manual processes.  

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Going Lean in Pharma and Healthcare

Lean validation is derived from the lean manufacturing process.  Simply put, lean manufacturing is the process of eliminating waste, minimizing risk and driving quality, efficiency and compliance.  A common misconception is that lean is suited only for manufacturing. This is not true. Lean principles may be applied to any process that would benefit from the elimination of wasteful activities and process improvement.  Lean validation thus is not a tactic or a cost reduction program, but a way of thinking and acting for today's validation team.  The figure below depicts the overall strategy for lean validation.

 

There are five principles of lean validation derived from lean manufacturing principles.  Lean validation is powered through people, processes and technology.  Automation drives lean validation processes.

Principle 1 – VALUE – Lean thinking in manufacturing begins with a detailed understanding of what value the customer assigns to product and services.  Lean thinking from an independent validation and verification perspective begins with a detailed understanding of the goals and objectives of the validation process and its adherence to compliance objectives.  The principle of VALUE requires the validation team to therefore focus on the elimination of waste to deliver the value the end customer (your organization) in the most cost-effective manner.  The computer systems validation process is designed for the purpose of assuring that software applications meet their intended use.  The value derived from the validation process is greater software quality, enhanced ability to identify software defects as a result of greater focus and elimination of inefficient and wasteful processes. AUTOMATION IS THE FOUNDATION THAT FACILITATES THE ACHIEVEMENT OF THIS VALUE PRINCIPLE.

Principle 2 – VALUE STREAM – The value stream, from a lean perspective is the comprehensive product life-cycle from the raw materials through customer’s end use, and ultimate disposal the product.  To effectively eliminate waste, the ultimate goal of lean validation, there must be an accurate and complete understanding of the value stream.  Validation processes must be examined end-to-end to determine what value is added to the objective of establishing software quality and compliance.  Any process that does not add value to the validation process should be eliminated.  We recommend value stream mapping for the validation process to understand where value is added and where non-value -added processes can be eliminated.  Typical "Muda" or wastes commonly revealed from validation process mapping are:

  • Wasteful Legacy Processes ("we have always done it this way")
  • Processes That Provide No Value To Software Quality At All
  • Manual Process Bottlenecks That Stifle Processes

Principle 3 – FLOW – The lean manufacturing principle of flow is about creating a value chain with no interruption in the production process and a state where each activity is fully in step with every other.  A comprehensive assessment and understanding of flow throughout the validation process is essential to the elimination of waste.  From a validation perspective, optimal flow is created through the process when, for example, users have the ability to automatically create requirements from test scripts for automated traceability thereby eliminating the process of manually tracing each test script to a requirement.  Another example is when a user has the ability to navigate through a software application and the test script process is automatically generated.  Once generated, it is automatically published to a document portal where it is routed electronically for review and approval.  All of this requires AUTOMATION to achieve the principle of FLOW.  For process optimization and quality control throughout the validation lifecycle, information should optimally flow throughout the validation process in an efficient manner minimizing process and document bottlenecks with traceability throughout the process.

Principle 4 – PULL – A pull system is a lean manufacturing is used to reduce waste in the production process. Components used in the manufacturing process are only replaced once they have been consumed so companies only make enough products to meet customer demand.  There is much waste in the validation process.  The PULL strategy for validation may be used to reduce wastes such as duplication of effort, streamlining test case development and execution, electronic signature routing/approval and many others.  Check out our blog "The Validation Post" for more information.

Principle 5 – PERFECTION – Validation processes are in constant pursuit of continuous improvement.  Automation is KEY.  Lean validation engineers and quality professional relentlessly drive for perfection. Step-by-step validation engineers must identify root causes of software issues, anomalies, and quality problems that affect the suitability of a system for production use. As computing systems environments evolve and become more complex and integrated, validation engineers must seek new, innovative ways to verify software quality and compliance in today’s advanced systems. Perfection cannot easily be achieved through manual processes. 

AUTOMATION IS REQUIRED TO TRULY REALIZE THE VISION OF THIS PRINCIPLE.

To learn more about how these services can be put into action for Pharmaceutical and Healthcare companies and how you can GO LEAN, please click on the link below.

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Accelerate Your ROI

One of the key benefits of ValidationMaster™ and our lean validation services is the excellent return on investment of the overall solution.  ValidationMaster™ is a full, comprehensive Enterprise Validation Lifecycle Management and Quality system.  Beyond the initial validation exercise, ValidationMaster™ pays dividends well beyond the initial validation exercise.  Many companies have seen a 100% return on investment with the first project.

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We invite you to access our Resource Center and read more about our Validation Accelerators.  Our Resource Center includes case studies, marketing collaterals and data sheets, white papers and much more.  Read our blog branded as The Validation Post for more detailed indepth strategies, best practices and thought leadership on lean validation strategies, Validation Accelerators and the latest innovations for validation project management.

Innovation In Action

Life sciences companies across the globe are seeing the benefits of our ValidationMaster™ Enterprise Validation Management System and CloudMaster 365™.  Instead of getting a stack of documents from a vendor, CloudMaster 365™ provides you with the system, the documentation, the testing, and the processes to help deliver validation.  Our clients have added their own due diligence to ensure compliance with current regulatory guidelines. 

Mastering Regulatory Compliance

CloudMaster 365™ is compliant with current global regulatory guidelines.  The ValidationMaster™ Enterprise Validation Lifecycle Management system includes compliance with 21 CFR Part 11, change control, regulatory content management, incident management, CAPA, nonconformances, training and other regulatory processes.  The system is designed to work together in a cohesive manner to deliver maximum value for lean validation processes.