By Valarie King-Bailey, OnShore Technology Group, Inc.
Lean manufacturing is founded on the principles of optimizing processes and eliminating waste (muda). In basic terms, lean means creating greater value and quality with fewer resources. The same lean principles used to optimize manufacturing processes can be applied to computer systems validation to help minimize waste throughout the validation process while driving greater efficiency and quality.
Today’s validation engineers are tasked with validating business systems that are increasing in complexity and more demanding from a compliance perspective. Lean validation can be applied to Microsoft Dynamics 365 for Operations (formerly Microsoft Dynamics AX) to eliminate waste and inefficiencies in the validation process while maximizing value.
We at OnShore Technology Group recommend the following five steps to preventing lean validation:
Figure 1 - Lean Validation Principles
PRINCIPLE 1 – IDENTIFY VALUE – Value derived from the validation process is greater software quality, enhanced ability to identify software defects due to greater focus, elimination of inefficient and wasteful practices, and the ability to implement, validate and deploy advanced technology in a more streamlined yet compliant manner.
PRINCIPLE 2 – MAP THE VALUE STREAM – Agile development processes call for optimized validation activities. For Dynamics 365 validation, we have examined validation cloud processes and mapped the value stream for greater optimization.
PRINCIPLE 3 – CREATE FLOW – Automation of the validation process is an essential strategy in eliminating waste. For D365, it is important to automate validation processes to ensure compliance and efficiency including test script development, execution, requirements management, incident management, requirements traceability and other activities. Although there are many tools on the market designed to address one or more of each of the document deliverables, only ValidationMaster offers a seamless flow of validation information from one lifecycle stage to the next. The system allows users to develop each requirement and link each requirement to a test script for automated traceability. The system automates the development of test scripts and allows users to directly export test scripts in company SOP-approved templates. Once complete, the recorded test script is seamlessly transferred to the ValidationMaster SharePoint-based portal for electronic review and approval. Once the script is pre-approved, it is executed (populated with actual results) and sent backs to the portal for review/approval. Forward and reverse traceability happens automatically and all documentation is archived in accordance with regulatory guidelines. With ValidationMaster, you have a single source of truth for all of your validation assets and the ability to create flow through automation of the validation process.
PRINCIPLE 4 – ESTABLISH “PULL” – One of the questions I am most often asked is how much validation due diligence is necessary to validate a system. From a validation perspective, pull refers to the level of validation due diligence required or “validate-only-as-necessary.” Using this principle helps you to drive validation based on risk and compliance objectives. It is important to understand that all systems are not created equal. One must understand the difference between COTS systems such as D365 and bespoke (custom) systems. The validation strategy must match the type of system to be validated. Leveraging this principle will keep you focused on your compliance and risk management objectives.
PRINCIPLE 5 – SEEK PERFECTION – A core tenant of quality is continuous improvement. While you may never achieve perfection in the pursuit of validation and quality objectives, it is important to drive towards “level 5” validation that ensures a consistent, repeatable process for validation, automation of the validation process to drive efficiency and the elimination of wasteful processes that increase the burdens and cost of validation. Following the principle of “seeking perfection” is a lofty goal but in a practical sense necessary as you seek to validate today’s advanced cloud technologies.
Cloud-based systems such as Dynamics 365 and Azure represent a significant change in the way systems are deployed. The principles of lean validation help keep you focused on what is most important and helps you achieve your business and compliance objectives. Cybersecurity and validation strategies must be changed to keep up with the pace of changing systems environments. For more information about cybersecurity and validation in the cloud, check out our webcast featuring Valarie King-Bailey: Validating Microsoft Dynamics 365 & Azure in the Cloud, as well as our next three upcoming webcasts in the series.
Learn how Edgewater Fullscope, an award-winning Microsoft manufacturing partner with nearly two decades of experience, can help you combat your toughest operational business challenges with Microsoft Dynamics 365 for Operations.