The Step By Step Guide to Creating A Validation Guide For An Assay Analytics

Assay Analytics
Assay Analytics

Assay validation is crucial for all bioanalytical assays. It helps establish recorded evidence for the ability of a specific assay and its instruments to produce a high level of consistent results. Method development and validation help document the accurate characteristics of the intended product. In addition, assay development and validation are integral components of all documents submitted for regulatory approval. This bioanalytics supports various aspects of clinical studies and product marketing.

Assay suitability must be tested and verified under actual real-life conditions. In addition, assay validation should consider recommendations from the International Conference on Harmonization (ICH) guidelines. These guidelines address various aspects of method development and validation. Assay development services should also validate methods that are outside the scope of ICH guidelines. Even the US FDA refers to ICH guidance. Hence, assay validation services must stay on top of these technical requirements.

The current article provides a step-by-step process to create a validation guide for assay analytics. There are several ways to validate an assay. Each of these approaches is acceptable when backed by several scientific justifications.

A validation guide for assay analytics

The first step in assay validation is to have a written protocol with steps clearly described in a step-by-step format. Moreover, this protocol must be approved before beginning the assay. The acceptance criteria can be modified based on the required sensitivity, accuracy, and assay of choice. Notably, the acceptance criteria are often derived from characterization studies. Moreover, one may omit some tests and modify the number of replicates on a case-to-case basis. However, each modification must be supported by scientifically sound arguments.

Assay validation is complete when that method fulfills all predetermined acceptance criteria. The following section provides a step-by-step validation guide for assay analytics. This brief guide complies with the quality system in the industry.

Each written and approved protocol must have an approval cover page. A lead controller will form a cross-functional team of personnel from different related and functional departments. The project controller will assign specific tasks and responsibilities to each team member. This cover page will comprise distinct areas where each phase of assay validation approval will be specified and documented. The different sections on the approval cover page will include summary information, project controller details, document approval, and revision history.

A written validation protocol has four main sections: purpose, overview, resources, and appendices. Let us delve into deep each of these sections.


The primary objective of this section is to provide a brief description of the aim of that particular study.


This section gives an overview of the test method, a summary of characterization experiments, identifying an ideal method and validation approach, validation protocol, applications and intended use of the bioanalytical assay, and performance parameters for each test method.


This section mentions the end user laboratory, equipment for method validation, materials and software, handling, and storage instructions.


This section contains a signature, references, and a review worksheet mentioning tasks and documentation training.

In addition, each assay validation protocol will have a list of additional software and equipment needed for validating assays.


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