What Is a Validation Plan?

A Validation Plan is defined as a management document that describes a project’s approach. The plan typically describes the work to be done, the resources needed, the methods to be used, the configuration management and quality assurance procedures to be followed, the schedules to be met, the project organization, and so on. It serves as a central part of the Process Qualification documentation. These plans also define the scope and goals of a validation project. A validation plan is usually written at the beginning of the project and is usually specific to a single validation project.

It is important to note that a validation plan is significantly different from a validation master plan. Although they sound and seem so similar in wording, validation master plans govern the validation activities of an entire site or organization while a validation plan only focuses on a single project.

Elements Of a Validation Plan

Here are some of the elements that should be included whenever you’re writing a validation plan:

Introduction and Scope. This section should include the system’s scope, the validation process’s objectives, and how the plan is reviewed, maintained, and updated. It should be noted, however, that these are only broad statements that will be supported by the sections that follow.System Overview. This section should include a description of the system in business language. It should also include a high-level description of the system, such as the general components, whether it connects to other systems, whether peripherals are included, how users will connect to the system, and so on. It is usually beneficial to include a system diagram so that executives can understand it more quickly.Organizational Structure. This section includes the roles and responsibilities of those involved, such as the general responsibilities of a project manager and the quality unit’s required participation. The identification of the process or system owner, which is the individual or group for whom the system is being validated, is critical in this section because it is this stakeholder who must be satisfied by the validation effort and who will be held directly responsible if validation is found to be insufficient during inspections.Quality Risk Management. This section should summarize any previous risk assessments that may have been used as inputs, quality management procedures or policies for conducting risk assessments, and the parameters for determining levels of regulatory impact. It should include a description of the overall quality risk management approach.Validation Strategy. This is the main point of the document. Based on the risk assessment, the system’s component architecture, and any required supplier assessments, this section will identify the strategy for achieving compliance and ensuring fitness for purpose. The identification of the validation lifecycle, inputs and outputs of each project stage, identification of hardware/software categories used to assess risk, acceptance criteria and methods of traceability, and design review will be the strategies used to achieve compliance.Deliverables. This section identifies each of the required deliverables and a responsibility assignment matrix for the responsible and informed persons. An example would be a RACI matrix (stands for responsible, accountable, consulted, and informed)Timelines and Responsibilities. In this section, a realistic timeline for each step of the process is provided, as well as the responsible department or person. Because validation can be a complex process involving a number of departments, it is critical to consider the schedules of all involved departments or personnel and then map the timelines.Acceptance Criteria. It is critical to understand the system acceptance criteria and how deviations should be handled. This will differ for each system under validation and will be determined by the business’s risk tolerance for the specific system and how fitness for intended use is defined. Keep in mind that these must be consistent with the organization’s overall validation policies.Change Control. In this section, identify the relevant procedures and tasks required to change the scope, responsibilities, and attributes of the project.Standard Operating Procedures. Each validated system must come with a set of Standard Operating Procedures (SOPs) outlining how the system is operated and controlled. This section is dedicated to outlining the requirements for each SOP. Keep in mind not only usage procedures, but also any implementation procedures that may be required during validation (for example, good documentation procedures), technical services procedures for system maintenance, and so on.

Factors Contributing To a Validation Project Failure

The failure of a validation project can be traced to the following factors:

Step by Step Process In Writing an Effective Validation Plan

Since the validation plan is considered by professionals to be a comprehensive evaluation of the validation process it needs to be written effectively. With that being said, here are the steps needed to make one:

  • 1. Start With the Introduction

    The introduction in a validation plan is an overview of the process, product, or equipment validation that should be consistent with the validation request. It will detail the steps necessary to complete the validation. Conformance to regulations and internal policy; the impact of a change on maintaining the validated state; any impact on regulatory submission; the impact of the change on procedures, drawings, and other documents; and notifications to internal and external groups impacted by the validation are all the steps or requirements necessary to complete the validation.

  • 2. Write the Technical Information

    A description of the product, process, or equipment, as well as any relevant formulae and specifications, will be included in the Technical Information. Any technical aspects of the validation or qualification, as well as any references to technical reports from the previous stage of process validation, must also be included in this section. The total validation approach should be included as well. This is based on what is known from experimental studies and previous data. This section will also include anything that will strengthen one’s validation process. Also, this section should include the total number of lots to be sampled as well as the associated risk to be described.

  • 3. State the Testing and Validation Strategies

    The general types of testing that will be performed, such as regulatory specifications, internal controls, and process tests, will be included in the validation strategy and testing and should be clearly stated in this step. The rationale for the test, as well as the sampling, will be described, and all of this should be based on a risk assessment. This step should include a description of how the data will be statistically treated with confidence limits, as well as a general overview of the acceptance criteria. It is critical to remember that the specifics of the topics covered in this section will be covered in the validation protocols. Remember that the validation plan is high-level and provides a bird’s-eye view of the process validation.

  • 4. Include Any Validation Documentation

    The plan should include a list of required documents for the entire validation. Identifying and assigning a number to each document required for validation will ensure that no protocols are overlooked. This section will provide administrative assistance in understanding what needs to be done to complete the validation and ensuring that those in charge do so. This section will primarily assist validation practitioners in organizing and determining the steps in a validation process that must be identified and documented.

  • 5. Cite Any References

    The reference section will contain a list of all documents that support validation. This is the link between the previous and current stages of the lifecycle approach to process validation. R&D technical reports, formulation and process development reports, and technology transfer or scale-up reports are some examples of documents included in the references.

  • 6. Finalize and Proofread

    When the writing of the validation plan is completed, take the time to carefully analyze it and proofread it. Any mistakes or shortcomings found must be corrected and remedied because any kind of mistakes in the validation plan can derail the entire validation process resulting in its complete failure. When everything is done, take the time to finalize the document and make it look professionally written.


What is the difference between verification and validation?

Verification is the process of checking whether the product is built according to the specifications that are given and meet all the quality requirements. If the product meets the requirements, it does not matter if it meets the needs of the customer. It is an internal process and is done by the quality control department. Validation, on the other hand, is the process of checking whether the product built is acceptable to the customers or not. It is an external process and the customer or customers will be the party doing the checks before the product is accepted by them. As implied, the suitability to customer needs is important in this step. The only way these two terms are similar is that they are both processes that involve checking all deliverables.

What is the difference between a Validation Plan and a Validation Master Plan?

Validation Plans specify the scope and objectives of a validation project. The Validation Plan is typically written at the beginning of the validation project (sometimes concurrently with the user requirement specification) and is unique to a single validation project. Validation Master Plans, on the other hand, discuss validation activities across an entire site or within an organization. The validation strategy is summarized in the Validation Master Plan. The Validation Master Plan’s purpose is to document the site’s compliance requirements and to ensure that adequate resources are available for validation projects.

What are deliverables?

The term “deliverables” is a project management term that traditionally refers to the quantifiable goods or services that must be provided upon project completion. Deliverables can be both tangible and intangible. For example, in a project aimed at improving a company’s technology, a deliverable could be the purchase of a dozen new computers. A deliverable in a software project, on the other hand, could refer to the implementation of a computer program aimed at improving a company’s accounts receivable computational efficiency.

The process of validation plays a great role in quality assurance and cost reduction of the product being made. It also ensures that the product being produced is fit for its intended use. It also serves as a key element of assuming the quality of the product. Therefore, having a validation plan in hand is essential for the entire validation project since it outlines what should be done (the goals and the entire scope) and keeps the project from going all over the place. In this article, examples of ready-made validation plans are available for you to download and use as a reference.