Validation planning is a structured approach to ensuring a machine or system meets all requirements before it is approved for production use. It begins with defining functional, performance, and safety requirements and continues throughout the project lifecycle, from design to acceptance testing. This dynamic process evolves alongside the project and adapts to new information, design changes, and customer needs. A comprehensive validation plan includes tools like design specifications, traceability documents, and testing protocols that guide and document every step.
Validation planning is more than a compliance exercise—it’s a proactive strategy that reduces risk, saves time, and protects product quality. Without it, manufacturers may face costly delays and miss specific build requirements.
ATS Industrial Automation supports validation master plans with a multidisciplinary team and decades of experience across regulated and complex industries, such as nuclear and automotive. We help manufacturers build practical validation strategies that align with real-world demand.
Validation Planning Helps Manufacturers
Manage evolving requirements: Without a structured plan, manufacturers risk overlooking critical performance parameters—especially as they evolve throughout the project.
Reduce schedule delays: When validation is an afterthought, it’s often compressed into the project’s final stages, leading to rushed execution or delays during factory acceptance testing (FAT) and site acceptance testing (SAT).
Optimize the use of product samples: It can be expensive to use production grade goods for late-stage equipment testing. Validation planning lets manufacturers explore lower-cost alternatives—like dry cycling or wet cycling equipment, or taking alternative approaches that may minimize the use of production components.
Improve record-keeping: A lack of preparation can result in incomplete documentation. A validation master plan incorporates specific tools to facilitate the development, tracking, and verification of all requirements during each project phase.
Reduce risk in regulated industries: Missing validation steps can have serious compliance and safety implications in sectors like nuclear, automotive, or life sciences. A validation plan ensures traceability that meets industry standards.
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Benefits of Validation Planning
Improve Interdisciplinary Collaboration
Multiple project disciplines including mechanical, electrical, software, and vision design teams use one framework, so all design elements are tested against the same requirements.
Product Samples and Quality Testing
A validation master plan anticipates which product samples and quality test equipment manufacturers will need to source—avoiding expensive, last-minute procurement.
Reduce Rework
Defining requirements from the start helps minimize late-stage design changes or misaligned functionality.
Strengthen Change Management
With structured requirements documentation and a live traceability matrix, manufacturers can assess product or process changes to ensure updates reach all validation steps.
Our Approach to Validation Planning
User Requirements Specification (URS)
This living document defines the set functional, performance, quality, and safety requirements that a machine or system are required to achieve.
Requirements Traceability
We map each requirement to corresponding design, development, and acceptance testing activities via a trace matrix, so each requirement can be traced through to final acceptance testing.
Functional Requirements Specification (FRS)
This documents how the machine will fulfill the user requirements including how it will function from a technical perspective.
Design Approvals
We document the formal internal and customer reviews and approvals of the proposed solution design documents, such as concept and final design reviews.
Acceptance Testing
During this stage, we test the equipment to ensure it meets the requirements set out at the beginning of the project. The form of testing may be industry or customer specific but could incorporate various test protocol documents including FAT, installation qualification (IQ), operational qualification (OQ), as well as final reporting.
