What Is Validation Protocol

A validation protocol is a plan written to describe the process to be validated. This includes production equipment and how validation will be performed. Such a plan would address objective test parameters, product and process characteristics. Predetermined specifications, and also factors that will determine acceptable results are also included.

What is Software Validation

Software validation confirms that particular specifications coincide with user needs; the software is meeting intended use and requires objective evidence that the requirements can be consistently fulfilled.

Designing a software validation plan before starting will save you time and money, therefore making the task manageable. It is vital to find a validation team that has the time and decision making authority to follow through each phase.

Standards of Validation Protocol

The process has become more regulated. In addition to this, simple English makes it easier to use. Therefore making sure that the operators and interpreters explicitly follow instructions written by its author. Hence if it is to be a stand-alone document that can be executed and reviewed as included in the operational qualification. Therefore,  the FT should first be written at the FAT stage. This means that your vendor should write it, and so the vendor does in a high percentage of instances. However, it is a crime that has spent hundreds of hours authoring, developing, and finally executing a detailed FAT at the factory. 

Parts of a Validation Protocol Document

Approval of the document

The protocol is reviewed by the head of the department, which is concerned. The quality assurance head approves it.

Protocol Aim

The goal of the validation protocol must be emphasized in the validation protocol’s objectives.

The Scope of the Protocol

This refers to the part of the validation, where the protocol will be used. Also, the particular department and its field with the contract is concerned.

Reason for Validation

The reason for the validation of the process or method must be clear.. Hence, if the product is new, then the latest technique or new product must be noted.

Criteria for Re-validation 

It is important to set a criteria for re-validation.

Duties and Responsibilities

 Defining the duties and responsibilities of every department concerned with the validation is a part of validation protocol.

Reference Documents

These refer to documents used for the completion of the validation activity. For instance, standard operating procedures and specifications. Likewise mentioning materials like analysis methods, BPR, BMR, and other protocols. 

Validation Procedures

This document must include the operating systems of equipment and sampling procedures. Likewise, the time for sampling , quantity, analysis method, and calculations.


All the differences from the written process that happened during the whole validation activity should be written. 

The Conclusion

 The validation activity must come with a conclusion. The conclusion must include the total results of the validation. It should also indicate the failure or success of validation.


Reports may include raw data compiled by one who is qualified. 

Approval of the Report

Then comes the review and approval of the report  by the quality assurance head.  By approving the report, this means that the validation process is complete and successful. Hence, in accordance with the validation protocol.

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