Software Verification and Validation (V&V) Overview and must-have Documents

The regulatory bodies have specific verification and validation requirements for manufacturing and quality systems. However, there is not much understanding of the actual requirements and the best practices for meeting the requirements in the industry. The concerned personnel must understand how to meet the V& V requirements and draft a software verification and validation report package and protocol. This article presents an overview and reviews the must-have documents for V&V.

What is software verification and validation (V&V)?

Verification

820.3(a) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

"Documented procedures, performed in the user environment, for obtaining, recording, and interpreting the results required to establish that predetermined specifications have been met" (AAMI).

Validation

820.3(z) Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

Process Validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
Design Validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).

"Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications" (AAMI).

Validation covers 3 activities as shown below:

Validation covers 3 activities

What are the systems that require verification and validation?

FDA requirement

Any software that is used for the design, manufacture, packaging, labeling, storage, installing and services of all finished products intended for human use should be validated.

ISO (International Organization for Standardization) and SOX (Sarbanes-Oxley) requirement

Software development process should be followed in areas where they apply to ensure that a specific process will consistently produce the expected results.

When you make an initial assessment of your system, you can arrive at a list of systems that will require validation based on the regulatory requirements mentioned above. However, there are eight common systems that fall under the control of FDA, ISO, and SOX.

Quality management system
Calibration management system
Maintenance management system
Document management/PLM system
Quality system platforms/server validation
Resource management system
Clinical data tracking databases
Labeling software

Of the above, the Document management/PLM system, Resource management system, and Quality system platforms/server validations affect multiple business units and most of these are configurable-off-the-shelf (COTS) software systems.

What are the must-have documents for software system V & V?

Software Validation Protocol (Validation Plan): A document that outlines the project deliverables and responsibilities.
System /Software Requirements Specification
Network Diagram
Risk Analysis
21 CFR Part 11 Compliance Analysis
Design Specification
Verification Protocol (Test Plan)
Test Specifications (Test Cases)
Requirements Traceability Matrix
Final Validation Report

3. Network Diagram

The network diagram document is a document required to illustrate how the system is configured on the network. It provides proof that you have a grasp of how the system is configured for your implementation.

4. Risk Analysis

The safety of the application and identification of potential hazards is a critical requirement. The risk analysis document should evaluate safety and identify potential hazards. Rather than the traditional failure mode effect analysis (FMEA) risk assessment for the software program which are part of the device and pose a patient risk, this document should focus of the business processes that the system manages. While few risks are exclusively mitigated by the software, few risks are procedurally mitigated.

5. 21 CFR Part 11 Compliance Analysis

The 21 CFR part 11 contains specific requirements for the use of electronic signature. The compliance analysis document evaluates the system applicability/requirements for its use as specified in the regulation.

6. Design specification

A document that indicates that the design criteria whereby the conformity with the requirement can be checked.

7. Verification Protocol (Test Plan)

Contents of the verification protocol define the type of tests to be performed and the procedures and schedules for tests. Example: Acceptance criteria, materials traceability, pre and post-conditions, procedures, requirement tags, standards references.

8. Test specifications (Test cases)

Test cases are documents used in the process. In software verification and validation, they are used to determine if the product is built according to the user requirements.

9. Requirements traceability matrix

This document links the requirements throughout the validation process. It ensures that all the requirements specified for a system are tested in test protocols.

10.

Attend the webinar drafting a software verification and validation report package and protocol to take a deep dive into the documentation required by the U.S. FDA for the verification and validation planning and execution of software after basic developmental testing and de-bug. In this webinar a suggested field-tested 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples. The focus of the webcast is on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 1) In-product, 2) As-product, 3) Production and test, and 4) QMS / 21 CFR Pt. 11.

The instructor John E. Lincoln has over 33 years' experience in U.S. FDA-regulated industries and 20 years as a full-time consultant. He has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.

FAQs on Software Verification and Validation

1. What exactly is software verification vs validation (V&V)?

Verification and validation (V&V) are two complementary processes used in regulated industries to make sure software is safe, effective, and compliant. Verification is about confirming that the software was built correctly — it meets the specified design and functional requirements. Validation, on the other hand, checks whether you're building the right software — that the system fulfills its intended use in the real world.

2. Why is V&V necessary for regulated software?

Regulatory bodies like the FDA require software used in critical systems — for example, in manufacturing, labeling, or clinical data tracking — to be validated. This ensures patient safety, data integrity, and consistent performance, and it provides clear documentation to auditors and regulators.

3. Which systems typically need verification and validation under regulations like FDA, ISO, and SOX?

According to ComplianceOnline, eight common types of systems are often subject to V&V under FDA, ISO, or SOX regulation: quality management systems, calibration management, maintenance management, document management (PLM), resource management, clinical data systems, labeling software, and quality-system platforms or servers. Many of these are configurable off-the-shelf (COTS) systems, making validation especially important.

4. What are the must-have documents for a proper software V&V package?

Here are the key documents, per the article:

Validation Plan (Protocol): Outlines project goals, scope, deliverables, and roles.
System / Software Requirements Specification: Defines what the system needs to do.
Network Diagram: Shows system architecture and how everything is connected.
Risk Analysis: Identifies potential hazards and how they’re mitigated.
21 CFR Part 11 Compliance Analysis: Evaluates how the system handles electronic records and signatures — crucial for FDA-regulated systems.
Design Specification: Details the design criteria that must meet the requirements.
Verification Protocol (Test Plan): Describes types of tests, schedule, pre-conditions/post-conditions, acceptance criteria, and more.
Test Specifications / Test Cases: Actual test cases used to verify functionality.
Requirements Traceability Matrix (RTM): Links requirements to tests, ensuring everything is covered.
Final Validation Report: Summarizes test results, deviations, risk mitigations, and conclusions.

5. What is risk analysis in the context of software V&V, and why is it important?

Risk analysis helps you proactively identify possible safety hazards, operational failures, or business risks in your software system. In the V&V process, this document is especially critical because it drives testing strategy, design decisions, and mitigation plans. Rather than focusing purely on system or device failure, risk analysis often centers on business processes — especially for configurable or COTS systems.

6. What role does 21 CFR Part 11 play in software V&V?

21 CFR Part 11 is an FDA regulation that governs electronic records and electronic signatures. For software used in regulated environments, a Part 11 Compliance Analysis is essential to verify whether the system meets electronic record-keeping and signature requirements, ensuring audit trails, security, integrity, and traceability.

7. How does the Requirements Traceability Matrix (RTM) help in V&V?

The RTM is a powerful document that creates a trace from each requirement (specified in the Requirements Specification) to its corresponding test case and validation status. This helps ensure nothing is missed — every requirement is verified, tested, and validated. It also provides clear evidence for audits.

8. Can you skip V&V for off-the-shelf (COTS) software?

Not always. Even if you're using COTS software, if it's part of a regulated system (e.g., quality management, or patient data management), you likely need to validate it. The article notes that many regulated systems are COTS, and proper V&V documentation is still required.

9. Why is a Final Validation Report important?

The Final Validation Report is your wrap-up: it consolidates all validation activity, test results, risk analysis, traceability, and any deviations. This is typically what auditors or regulatory bodies will examine to confirm that your system meets compliance, safety, and quality standards.

10. When should V&V planning start in the software development lifecycle?

V&V planning should ideally start very early, during or soon after system requirements definition. This ensures that validation requirements influence design, risk assessment, and test strategy from the start, making later phases smoother and more compliant.

Compliance Trainings on Software Verification and Validation

2-Day Virtual Seminar : Verification and Validation - Product, Equipment/Process, Software and QMS
Get trained on the concept of verification and validation and learn how to develop protocols for products, process, equipment, software and quality management system.

One and a Half Day Virtual Seminar : Analytical Method Validation, Verification and Transfer
Reliable analytical results are necessary to make informed decision about the quality and safety of the products in the pharmaceutical industry. In addition, such analytical data are required for regulatory submissions in support of the drug product registrations.

2-Day Virtual Seminar : Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
This 2-day seminar will help attendees to understand regulatory requirements for method validation, verification and transfer. It will also suggest ways to de-risk the method validation process through prior evaluation of method performance and the use of effective protocols.

The 6 Most Common Problems in FDA Software Validation and Verification
This webinar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. Corporate uncertainty leads to inaction and “wheel spinning.” Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards.

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
This course will train attendees on best practices to create a spreadsheet that is GxP compliant using Microsoft Excel. Attendees will understand how to validate applications with minimal documentation. The course will also offer step-by-step instructions to configure Excel for audit trails, security features, and data entry verification. This session will also include an interactive workshop for participants to learn important techniques for using Excel spreadsheets for GxP data.

Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies
This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.

Analytical Method Validation and Transfer
This course will provide a thorough review of regulatory guidelines on method validation and transfer. It provides guidance on how to perform QC analytical test method validations and transfers.

Ethylene Oxide and Gamma Radiation Sterilization Validations
Some of the most important V&V's for medical products is sterilization validation. They are also among the most expensive. It's important to get them right for many reasons, especially patient safety. What are the regulatory and documentation requirements? How does risk-based safety V&V planning / execution function and how documented per ISO 14971 and ICH Q9? This webinar look at the entire V&V process and will present several Test Case formats and Test Report / Protocol examples in harmony with ISO 11135 (EO) and ISO 11137 (Gamma).

FDA's New Software Validation Requirements
CGMP companies must develop / implement formal software V&V for medical product under IEC 62304 and a key US FDA Guidance Document.

Test Method / Design Verification and Validation
Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design Verification and Validation under U.S. FDA cGMP, EU MRD and ISO 14971

Process Validation Requirements & Compliance Strategies
This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.

Validation Sampling Plans
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.

Conducting Remote Medical Device QMS Audits Training
Remote QMS-CGMP compliance inspections are here to stay. Add it to your toolbox for vendor and remote site audits, especially for low to moderate risk companies.

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested field-tested individual V&V plans, Test Report / Protocol formats, and individual test cases, IQ, OQ, and PQs, are presented.

Implementing a Quality Management System
This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.

Metrics and Management for a Suitable and Effective QMS
This webinar will highlight metrics to ensure your management is well informed on the health of the QMS, and provides the right level of oversight, attention, and resources.

The Importance of Packaging and Labeling in Pharmaceutical Product Development
Packaging and labeling is often underestimated in the planning phases of pharmaceutical product development. This leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. This webinar will help you succeed in pharmaceutical product launch by exploring its importance right from the conception of a product, its realization and distribution.

Validation Master Plan - The Unwritten Requirements
This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

Verification vs. Validation in FDA Regulated Industries
This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries. Learn about the risks and complications involved with the application of sound verification and validation principles.

Medical Device Process Validation Training for Professionals
This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, EU MDR, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

Understanding FDA Design Verification and Validation Requirements for Medical Devices
This webinar will help you understand specific product verification and validation requirements for medical devices to comply with ISO 13485: 2016 and FDA quality system regulations. It will focus on the topics such as product development process, traceability and risk management at all stages, design outputs and documentation in DMR and DHR, design verification and design validation activity cycles and more.

Medical Device Software Verification and Validation
This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.

Lifecycle Approach to Analytical Methods with QbD Elements: Design, Development, Validation, Transfer
This training on using the QbD Approach to Analytical Method Lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements.

Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts
This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.

Verification vs Validation in Regulated Industries
FDA regulations as well as European standards such as ISO 13485:2003 require both verification & validation documentation throughout these regulations and standards. The terms apply to design control, process control and others. This presentation will define and explain the differences (& similarities) in these terms and how they apply to regulated industries as well as the consequences of poor adherence.

Verification or Validation of Methods in Food Microbiology
This webinar will not only address the semantics, but will also discuss the appropriate analytical and statistical approaches to achieving successful verification and validation studies with respect to food microbiology. The quantitative and qualitative methods of performance measurement will be discussed for verification and validation.

3hr Virtual Seminar - Validation, Verification and Transfer of Analytical Methods – Implementing Guidelines from FDA/EMA, USP and ICH
This 3-Hr webinar on “Validation and Verification of Analytical Methods” by Dr. Huber will discuss the recent changes in guidance from regulatory agencies (FDA/EMA, USP and ICH) on method validation and transfer, integrated validation, verification and validation of analytical procedures for equivalency testing and statistical evaluation.

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